Study Setup Administration

Transcription

1 Content Study Setup Administration...3 ground...3 Related content...4 Requirements...4 Process information...4 Prerequisite...6 How to Manage Study Setup...6 Site/Patient Enrolment...7 Enrollment menu considerations...7 Study Set-up Progress Report...8 Copy Study Metadata and Init....8 Copy Study Module...9 Move Study to PRODuction...9 Move Study to EDUcation...9 Study Initiation (a)...9 Select Study to initiate and type of Initiation Normal Initiation Re-initiation Advanced Initiation Study Initiation Many Sites Site/Patient Enrolment Study Initialization Define Study Visits (b) Define Study Sites (c) Define Site Enrolment check Range (d) With defined site ranges With a study ranges Allowed Site Range Range assignment checking Range accepted message Range accepted but range assignments not completed Allowed Study Range CDM Site Enrolment (Data Entry Site Enrolment task) Study Module Management (e) Add Module to Study Normal-type, non repeat module: Normal-type, repeat module: Manage Module in Study Edit Module Edit Module Update Variables Change Entry order of variables Change storage length of a variable Change Module Included Variables Considerations Attributes Preview DE Screen DE Screen Editor Module Validation Update Study Modules Close Study Module Management Define Data Entry Book (f) Normal Advanced On Line PheedIt of 77

2 Save Confirmation Set User Study Role (g) Set Visibility by Role (f) Authentication Signature (i) Export Study Metadata (j) Define DE Study Password Study Activate/Deactivate Define FDE Prompt Char Generate CRF Annotated CRF Sample Annotated CRF Printable CRF Sample Printable CRF Variable Entry Validation Data Entry Online Manual Related menus Reference Documentation On Line PheedIt of 77

3 Study Setup Administration ground The PheedIt Study Designer Role manages Study Setup in the system, by combining the metadata created by the Librarian with study specific content. Study setup begins with creating the study specific database initiation (a). Then continues with specifying visits (b) and if in use specify named sites (c) and in the latter case specifications of the maximum range of subjects per site or if numbers are picked from a study range (d). Study Module Management (SMM) represent the main study design work is the work to add and manage modules (entry screens) as required (e) and adopt them to study level requirements the work continues with specifying the use of entry screens by visit (f). For studies designed to utilize visibility and freeze utilities you continue and set the role a study user has in the study (g) then you continue and assign visibility of modules to roles (h) finally you need to save study metadata (i) these actions complete the Set-up progress as is reported in the Study setup Study set-up Progress Report menu item. When study setup is completed then the study is opened for data entry. If changes are made to a study setup data entry will be blocked until update process tasks are completed. The system allows for several different routes of study conduct, the selected route was defined by the Librarian when defining the study metadata. This has an impact on study setup. Another important issue is data verification and the use of the different available means to qualify data entries. The Study Designer is one of the roles interacting with CDM and DVM Manager to test the study setup by means of test data entry to verify and stress the applied verification methods. Site Access is granted in PheedIt according to the study design established in the system. This facilitates access where remote data entry is used and patient positions are allocated dynamically by on-site investigators as the study progresses during data entry. In study designs using Site/Patient Enrolment, the Librarian defines the resources required. Resources are primarily retrieved from the database containing investigator site information (Administration Site Definition). Resources can also be retrieved from the investigator database that contains investigator information including their relation to a site or sites. Study designs using Site/Patient Enrolment also require the Study Designer to allocate sites in the system to the study (Study Setup Define Study Sites). The sites allocated this way are included in selection lists used in the system, including listings for Data Entry Site Enrolment, Data Entry Patient Enrolment, Data Entry Next Patient Enrolment the enrolment status is reported using the, Data Entry Enrolment Report and for the entry screen Patient Information when this is used. Note! If study sites are not defined in Study Setup Define Study Sites, then all sites in the study are shown in lists displayed for enrolment or for Patient Information entry screens. Studies which do not use Site/Patient Enrolment must still use Study Setup Define Study Sites to set which sites are displayed for Patient Information entry screens. Note! The access granted, as described below, controls the view displayed to each PheedIt User. The system ensures that Users can only view data associated with the site to which they are granted access. Further, PheedIt Users can only select from sites specified in the access grants set by the PheedIt Administrator in the Administration Site Access menu. On Line PheedIt Study Setup Administration 3 of 77

4 Related content Managing and administering Site access must be considered when planning the study and selecting the study design. This is related to the planned use of the data and therefore data entry during the study. In studies using remote data entry, we recommend that Administrators assign a Librarian role to specific sites; that user access is granted through each site, and that site/patient enrolment is enabled for the CDM/Investigator role Requirements Study Setup requires that all elements of the entry forms to be used are created in the library by the Librarian. The Administrator needs to be informed about the access requirements for the study, especially when remote data entry is at hand. Site Access grants can be used when the study definition uses Sites and Enrolment by site or by patient. Before the Site Access function can be used, sites must be defined in the global library (by the Librarian) and sites must be allocated to the study (by the Study Definer). Administrators grant site access to Users by selecting the appropriate sites. Process information Using the Study Setup menu item is a routine task for Study Designers who adjust library recourses to the individuality of the single study. This is typically a collaborative work shared with the Librarian and CDM. When the study has been designed testing is required to verify the use of variable validation checks and that DVM management will work as intended. The PheedIt development environment is intended to be used while developing the study up to and including testing using suitable test data. All changes to the study design is intended to be performed in this environment. Thus you need to be relaxed and confident in the study design and receive approval that implemented solutions are acceptable prior to moving the study design into the production environment. Performing amendment changes or design changes in production is much more tedious! As care of production data require attention. Basic Study Setup process tasks principal flow as indicated with letters a-i in process flow shown below and in the Study Setup menu: Study Definer Study Setup menu items On Line PheedIt Study Setup Administration 4 of 77

5 PheedIt provide the menu tasks as some tasks typically are used repeatedly and not necessarily always in the indicated preferable flow order. Depending on the study attributes (defined in Library Study Definition) the study setup requires different tasks to be performed. The matrix below describes what tasks are necessary for each study type. Mandatory tasks for all studies Study set-up Procress Report Study Initiation (a) Define Study Visits (b) Study Module Management (e) Define Data Entry Book (f) Tasks available for studies with Site/Patient Enrolment = YES Define Study Sites (c) Define Enrol. Check Range (d) Tasks available for studies with Freeze/Visibility = YES Tasks available for studies with Authentication Signature enabled Export Study Metadata (j) Set User Study Role (g) Visibilty by Role (h) Authentication Signature (i) To follow the progress of the Study Setup tasks a report is available. In the report tasks that need action is displayed in red. Use the study selector to select study where the Study Setup process progress is to be investigated. On Line PheedIt Study Setup Administration 5 of 77

6 The Study Setup process involves tasks performed in a chain of interrelated sub-processes. The principal order of work is always a-j, however c-d and g-h may not be in use and task a is not the natural starting point when edits are made to a study setup. Export Study Metadata must be performed to release the study for data entry. If a study setup is changed when data entry has occurred, data entry will be blocked until the study setup change task has been completed. The Study Set-up Process Report contain active buttons and may be used to go through the study setup tasks as an alternative to the Study Setup menu. Prerequisite To be able to work with a study the study metadata must be defined by the Librarian. Use the User Menu User Study Selection to set the study at hand to your default selection, this saves a lot of work when using menus. And Yes; the Super Administrator must grant you the right to work with the study to enable this feature. How to Manage Study Setup Study Setup is the process where the physical database for a study is created. All studies must be initiated. The application allows for several study designs. Study design is defined in the Study metadata definition performed by the Librarian; already here the set of studies are split into two different groups: Studies designed to use Site/Patient Enrolment or patient inclusion, I.E. named sites. When this design is in use you may apply site access restraints, thus limiting the view for data entry to granted sites. Studies intended for remote data entry should use the Site/Patient Enrolment. On Line PheedIt Study Setup Administration 6 of 77

7 Studies designed not to use this feature, may be initialized using either o Normal setup, you state patient position ranges o Advanced setup, you get assistance in generating "pseudo" group patient position ranges. This design is mainly applicable to in-house data entry from paper CRF and for test purposes. Use the Study set-up progress report to follow up on study setup status the report also act as an alternative route to using the menu items when performing study setup tasks, you do not need to select study between tasks. Site/Patient Enrolment Site/Patient Enrolment is used whenever you would like to combine a users access grants with study data entry capabilities. A study configured to use Site/Patient enrolment enable control over which users have access to perform data entry or to view entry screens. This access grants are managed by the PheedIt Super Administrator. When site or patient inclusion is in use, the Librarian and the Super Administrator need to be informed about the relation between named sites (to be created by the Librarian and access grants performed by the Super Administrator) and persons allocated roles as Data Entry and Investigator etc. Further the Study Definer needs to know which named sites to allocate to the study. The Super Administrator need to define all the named sites to be used in a specific study in the Library using the menu: Administration Site Definition, prior to Study Definer use of the named sites in a study. Study designs not using the named sites feature may use patient position numbering schemes to address the issue of distinguishing patients from different sites. Enrollment menu considerations In a patient enrollment study, the subjects are enrolled by the remote sites, i.e. the Investigator. For enrollment of patients there are several menus available: Data Entry Site Enrolment (Allow batch enrollment) Data Entry Patient Enrolment (Single Subject enrollment one at a time, sequential enrollment not required) Data Entry Next Patient Enrolment (Sequential enrollment of subjects either site sequential or study sequential as defined in study setup) As a study administrator you need to decide what menu items to use in the study. To display all menus is often both confusing for the remote site users and could also cause some unwanted id allocations. The Site Enrolment menu will allow the end user to enroll several subject ids at the same time in a defined range. The Patient Enrolment menu will enroll ONE subject id at a time, with an id defined by the user, as long as the id is inside the defined site or study check range. The Next Patient Enrolment menu will enroll ONE subject id at a time, with a predefined id by the system. The system will take the maximum subject id already entered in the system, and suggest the next following id. If you present all menus to end users you might experience inconsistency. For example if you allow both Patient Enrolment and Next Patient Enrolment there might be gaps in the range: First five patients for the site, with given a range from , are enrolled with Next Patient Enrolment allocating subject id 101, 102, 103, 104 and 105. A Patient Enrolment is done for id 189. The following Next Patient Enrolment will allocate subject id 190. On Line PheedIt Study Setup Administration 7 of 77

8 As you can see from the example above there will be a gap in the range from 105 to 189 that will not be filled be Next Patient Enrolment. To ensure a consistent range (without gaps) remove the Patient Enrolment menu for the remote site users. Make sure that you evaluate the needs and requirements for your specific study, and display only the relevant menus for the remote site users based on that. Study Set-up Progress Report To facilitate overview of the Study Setup process progress we have added the Study Set-up Progress Report menu task. This interface generates a study set-up process progress report based on study definition and presents a graphical view over task completion status. A study setup must be completed to enable data entry in the study. When performing adjustments or edits to the Study set-up this report is useful to ensure that all required tasks are completed. The progress report displays the set of requested tasks to be performed depending on study definition: classic or site/patient enrolment as well as use of freeze/visibility functionality. Tasks not green indicate tasks to be performed, illustrated above. The situation above indicates that additional Study Module Management was done to a study metadata that require update of the data entry book definition, Note! All changes to study metadata require additional save of metadata prior to enabling data entry in the study. Copy Study Metadata and Init. This interface enables metadata copy between a existing initialized study to a defined but not yet initialized study. In the copy process you are enabled to deselect modules to be copied, you decide if patient positions are copied or not. The task will initiate the target study! No study data is copied. This task is further described in a separate document. On Line PheedIt Study Setup Administration 8 of 77

9 Copy Study Module This interface enables metadata copy between existing initialized studies to a defined and initialized study. This task allows copying modules from one or more studies to a single study. All study module local settings including layout is copied. No study data is copied. This task is further described in a separate document. If you plan to use this functionality the tasks performed by the Librarian should include defining a Selarate Librarian (possibly per groop) named study where Library defined (and thus with default layout) are defined and the module layout design is prepared. Later Study Definers are instructed to use the Copy Study Module- task instead of Study Module Management Add Module when incorporating a module where the layout have been specially adjusted. Move Study to PRODuction When a study has been tested in the development environment and is ready for use in production this menu task allows for the metadata transfer (synchronization process) from development to the production environment. No study entry screen data will be transferred. Study will be initialized in the production environment. Study move may require update of formats in the target production environment! As format item changes are not automatically propagated. Please use the report available as menu item: Administration - Library Administration - Library Metadata Audit - Format Metadata Audit - Format Compare Dev versus Prod to document if format definition differences occur that affect the study to be transferred. The Synchronization process interpreted as follows, if target already contains metadata with the same name metadata will NOT be copied from source to target (manual resolution required). When named metadata do not exist in target metadata will be copied from source. Note 1! Changes to a Named Format specification like adding, removing or editing a format item will not propagate if Named format exist in target environment. Note 2! Moving a study from Development-environment to Production-environment will Not change modify any existing modules in the target production environment. If Librarian identify that changes need to be performed on a module design based on tests in Development. In cases where module metadata was transferred to Production prior to changes, then changes need to be manually performed in Production! Seriously consider an alternate path, use the Library Module Copy Existing and use a new module name to represent the new design. The task of performing Move Study to PRODuction is further described in a separate document. Move Study to EDUcation Similar to Study Setup Move to Production, provide means to transfer study metadata definitions from development to the PheedIt education environment. Synchronization process rules apply. This task is further described in a separate document. Study Initiation (a) Study initiation, this is when you create the physical study database, may be performed several ways; On Line PheedIt Study Setup Administration 9 of 77

10 Copy study is one method, Study initiation (normal mode) and Study initiation (advanced mode) are another and Finally Study initiation (normal mode) on studies with metadata configured for Site/Patient enrolment is the last. Select Study to initiate and type of Initiation Screen title Select Study Use Advanced Initiation Close Next Task Step Select named study to initiate. Tick the checkbox if you chose the advanced initiation method. The advanced initiation allows for an automated group numbering scheme. Group is a way of generating pseudo site grouping where group=site and site is part of subject ID (predefined positions in ID number). Close/Cancel task Press Next Task Step - button to confirm selections and proceed. Selected study will be used as input to next step. Normal Initiation Normal study initiation requires that you specify the patient number ranges to use. Thus patient may be grouped by this number ranges. On Line PheedIt Study Setup Administration 10 of 77

11 Screen header I - icon Study name Study Number of patients Number of visits Active users Study Active Patient No. Specification Information icon for links to this document. Documents the selected study to be initiated. Presents the study title The planned number of patients stated in study metadata. The planned number of visits as stated in study metadata. List of users with active status set. Presents study status (A=active, N= Non Active) Press to reset any changes made in the screen. You can then repeat the steps above to grant site access. Field is mandatory Initiate Study for Data Entry, however you may perform changes later end update the patient position numbers later. Note! By design the possibilities to define many pseudo site ranges is limited to the number of characters allowed by the specification string (80- characters. If your study need several sites consider use of the advanced initiation alternative described below or switch design and use the Site/Patient study design) Press to close the screen and return to the Initiate Study Select Study screen. Press to perform selected action with attributes set. The study database will be physically created. The initiation of the new study, and thus the creation of folders and default study recourses are confirmed by the following screen. On Line PheedIt Study Setup Administration 11 of 77

12 Close Progress Followed by task progress information. Invokes the study select interface for Study Initiation Press to close the screen and end the task, the clear bulletin board is displayed. Press Progress-Button to be transferred to the Study Setup Process Progress Chart for the currently selected study. Re-initiation It is allowed to re-initiate a study. This is only relevant for On the other hand for non Site/Patient Enrolment studies PheedIt allows the users to add new patients to an already initiated study. Be aware that when re-initiating a non Site/Patient Enrolment study you may change the allocated patient positions. Screen header I icon Study name Study Number of patients Number of visits Information icon for links to this document. Documents the selected study to be initiated. Presents the study title The planned number of patients stated in study metadata. The planned number of visits as stated in study metadata. On Line PheedIt Study Setup Administration 12 of 77

13 Active users Study Active Patient No. Specification List of users with active status set. Presents study status (A=active, N= Non Active) Make changes to patient positions, by adding. Field is mandatory Update Patient Numbers, however you may perform changes later end update the patient position numbers later. Press to close the screen and return to the Initiate Study Select Study screen. Press to perform selected action with updated patient position numbers. The study patient positions will be updated. Clear Progress Followed by task progress information. Invokes the study select interface for Study Initiation Clear/Cancel to close the screen and end the task, the clear bulletin board is displayed. Press Progress-Button to be transferred to the Study Setup Process Progress Chart for the currently selected study. Advanced Initiation Advanced Study Initiation differs from Normal, you may specify number of patient groups you need, then by specifying number of patients per group and patient number positions. The patient position numbers are generated by the application based on stated information. Note! It is possible to change from Normal to Advanced but not the other direction. The maximum number of groups/sites that could be allocated in advanced initiation is 999 groups/sites. If the study requires additional sites (to the 999 sites) of this type, use Study Setup - Study Initiation many sites which allows a maximum of sites. Note the difference between site/patient enrolment and this grouping of patients. On Line PheedIt Study Setup Administration 13 of 77

14 Screen header I icon Study name Study Number of patients Number of visits Active users Study Active No. of Patient groups (i.e.sites) Patient No. per group Patient No. positions Update Patient Numbers Information icon for links to this document. Documents the selected study to be initiated. Presents the study title The planned number of patients stated in study metadata. The planned number of visits as stated in study metadata. List of users with active status set. Presents study status (A=active, N= Non Active) Enter number of groups (i.e. sites). Sample: 3. Enter number of patients max per group. Sample: 12. Enter number of positions. Sample: 4. Press to close the screen and return to the Initiate Study Select Study screen. Press to perform selected action with updated patient position numbers. The study patient positions will be updated. Using the sample values in the table above, the patient positions will be numbered , , and A confirmation page informs that study settings have been updated. On Line PheedIt Study Setup Administration 14 of 77

15 Close Followed by task progress information. Invokes the study select interface for Study Initiation Press to close the screen and end the task, the clear bulletin board is displayed. Study Initiation Many Sites Note! This menu-item is by default removed in a standard 3.03 release! (Contact SAS Institute if you need it) An initialization possibility allowing sites has been made available advanced initiation allow for groups/sites, on the other hand the patient number range is more limited 2-digits less per site. The maximum patient number may contain 12 digits. Site/Patient Enrolment Study Initialization If you initialize a Site/Patient enrolment study, the following confirmation screen will appear: Study Information Followed by task progress information. Table of Study Definition Information, this study is not active. Study do not require specification of patient positions, this will be done using either Data Entry Site Enrolment or Data Entry Patient Enrolment. Note! If Site Enrolment is used it is possible to add individual patients using Data Entry Patient Enrolment if needed. On Line PheedIt Study Setup Administration 15 of 77

16 Initiate Study for Data Entry Press this button to generate/initiate study database. Invokes the study select interface for Study Initiation Define Study Visits (b) At least one study visit needs to be defined. Visits are named events in time which involves querying the patient for data to be captured in data entry screens. Visits are a study specific special case selection list, visits are sequentially ordered using the visit order, start out using integer numbers, if required you may enter real number if you need to add visits in between existing visits. You may add visits to running studies, however concern need to be taken especially in production environment if you intend to change the visit description. Visit description is an observation key value; the value saved with data is the Visit text. Warning! If in a study open for data entry is adjusted such that visit description is changed, entered data is not lost but made inaccessible in the interface due to the change of the identity value Visit. Best approach is to maintain a standardized set of visit descriptions to be reused between studies. Selected study Close Next Task Step Select study name. (Type of study enrolment design: [N] normal [A] advanced [SP] Site/Patient enrolment) Close/Cancel task Press Next Task Step -button to proceed to the visit definition screen with the selected study. On Line PheedIt Study Setup Administration 16 of 77

17 Yes you are required to select a study. I - icon Selected study Add Observations Create/Update Study Visits Visit Order Number (Column) Information icon for links to this document. Currently Selected study name. Press this button to return to the study selection screen. When you reach 50 visits and are requesting more visits, save the first 50, then use this button to generate an interface allowing definition of visit 51 to 100, etc Press to save the visit specifications/edits made. Enter digits stating the orderable number of the visit at each row. Normally use integer numbering this will allow adding additional visits in between by use of decimals, 5,6 then define 5.1 to be placed in between. On Line PheedIt Study Setup Administration 17 of 77

18 Visit Text Create/Update Study Visits Enter a text describing the visit. Note! If you require special characters you need to use HTML coding, see Library Web characters for symbol code We use the html character code to enable use of visual characters. Visit descriptions containing such symbols will be exported as defined, i.e. containing the html-code. Typically less than < and greater than > is considered special characters. Press to return to the study selection screen. Press to save the visit specifications made. Clear Progress Followed by task progress information. Invokes the study select interface for Define Study Visits Use when you have committed the first 50 visit definitions and need to add additional visits Press to clear the screen and end the task, the clear bulletin board is displayed. Press Progress button to display the study set-up progress chart of the current study. Note! Study visits may be edited and visits added as needs arise and the study progress. If new visits are added you need to use the Define Data Entry Book menu to update the information about which modules to use in combination with the new visit. Define Study Sites (c) Studies defined to use Site/Patient Enrolment, require information on which named sites to associate with the study. Named sites are created by the Librarian. The Study Definer allocates the studies to a study. On Line PheedIt Study Setup Administration 18 of 77

19 Select study Close Next Task Step Select study where you need to assign site. (List restricted to Site/Patient[SP] defined studies) Note! The interface filters on user study AND site access grants. Close/Cancel step Press Next task Step -button to continue to the include site selection screen. Yes you are required to select a study. On Line PheedIt Study Setup Administration 19 of 77

20 I - icon Selected Study Information Batch group of sites list Print Next Information icon for links to this document. Selected study name to perform site management definition for. If the number of Library defined sites is larger than 100 the interface will require that you select batch group of sites to work with. A list of batch groups is shown, to create the list sites was sorted on Name/ID and range end names are presented as a hint if you look for a specific site. Return back to study selection list. Press to bring up the client print capabilities. Press to display batch group selected On Line PheedIt Study Setup Administration 20 of 77

21 I - icon Selected Study Column Site ID/Name Entry mode is shown one of; New or Edit Information icon for links to this document. Selected study name to perform site management definition for. Note! The interface filter on user site access grants. Name of sites as declared in Administration Library Administration Define Site. Column to the right of Site ID/Name Save Note! As study definer You will see all Sites defined. A user of the study will only see the sites granted to the user. Checkbox, tick the sites to include in the study. Return back to study selection list. Press to save checkbox selections made. On Line PheedIt Study Setup Administration 21 of 77

22 Clear Progress Followed by task progress information. Invokes the study select interface for Define Study Sites Press to clear the screen and end the task, the clear bulletin board is displayed. Press Progress button to display the study set-up progress chart of the current study. Define Site Enrolment check Range (d) Studies defined to use Site/Patient Enrolment, require information on ranges. During Study definition you can select between: Site Patient Enrolment With defined site ranges Site Patient Enrolment With a study range With defined site ranges For the studies with this setting you set ranges for the selected sites included in the study. These ranges are basically allowed ranges for a specific site in the selected study. The purpose of this step is to create different allowed ranges for different studies to minimize the range conflicts when performing site enrolment and patient enrolment. With a study ranges For the studies with this setting you set one common range that is used by all the sites included in the study. The range is basically an allowed range for creating subject ids in the study. The sites can enroll patients in a non-site order with this setting. Example: Site A enrolls 101 Site B enrolls 102 Site A enrolls 103 Site C enrolls 104 Site C enrolls 105 Site A enrolls 106 Note: we recommend to use ranges with enough gap so additional patients in the study can be added, i.e. if you re planning to enroll 1-20 for a specific site/study, let the allowed range for that specific site/study have a range of 1-40 in case of additional patients in the study (for the site). On Line PheedIt Study Setup Administration 22 of 77

23 Allowed Site Range Select study Close Next Task Step Select study where you need to assign site ranges. Only studies defined to use Site/Patient[SP] enrollment are displayed. Note! The interface filters on user study AND site access grants. Close/Cancel task Press Next Task Step -button to continue to assign ranges for the sites included in the selected study. Yes you are required to select a study. For studies with enrolment setting: With defined site ranges: On Line PheedIt Study Setup Administration 23 of 77

24 In the sample above less than 20 sites are allocated to the study. If the number is larger the interface whitches to a selection list for batches of 20 assigned sites. And you are requested to select a batch group. In this case continue with sample using the second range display: On Line PheedIt Study Setup Administration 24 of 77

25 I - icon Selected Study Column Site ID/Name Column to the right of Site ID/Name Save Information icon for links to this document. Selected study name to perform site range enrolment for. Name of sites as declared in Administration Define Site. Note! Only sites that are included for the selected study are displayed. Minimum to maximum patient s number for the sites. Return back to study selection list. Press to save ranges for the sites. Range assignment checking Due to the many combinations possible the assigned sites are checked when you press Save-button. In the case the site range definitions are consistent you will be displayed the following message: Range accepted message Selected Study Selected study name to perform site range enrolment for. On Line PheedIt Study Setup Administration 25 of 77

26 Enrollment check range message Print Report Clear Progress Allocation of the check ranges was accepted Return back to study batch selection. Use client print capabilities Press to be transferred to the Site Enrollment Report. Press to end task. Press to be transferred to the Study Setup Progress Report Range accepted but range assignments not completed Assignments of site control ranges are mandatory to enable release of study for data entry. If the assignment of site ranges is not completed the following message appear: Selected Study Enrollment check range message Print Report Clear Progress Selected study name to perform site range enrolment for. Allocation of the check ranges was accepted, indicated by green message text and Done. Red note indicate that not all sites have received their site check range definitions, use back to proceed with the definition in all allocated batches of sites in the study Return back to study batch selection. Use client print capabilities Press to be transferred to the Site Enrollment Report. Press to end task. Note: Button removed as task is not completed! If the specified site range collide with other site range specifications this will be reported: On Line PheedIt Study Setup Administration 26 of 77

27 Print report to assist when resolving issue. Validation Report Save conclusion Print Report Clear A validation report is presented if conflicting site range specifications are found. Print report and use it to revise your range specifications. Errors in range specifications provided found: NO data saved Return back to site batch list. Current will be default. Use web client to print validation report Press to go directly to the Site Enrolment Report for the current study. End Task. Note! If definition errors are found, no ranges will be saved of the provided batch values, yes this by design may result in you need to redo up to twenty range assignments. Allowed Study Range For studies with enrolment setting: With a study range: On Line PheedIt Study Setup Administration 27 of 77

28 I - icon Selected Study Column Study Column to the right of Study Save Information icon for links to this document. Selected study name to perform site range enrolment for. Name of study as declared in Library Study Definition. Minimum to maximum patient s number for the study. Return back to study selection list. Press to save ranges for the sites. Close Progress Followed by task progress information. Invokes the study select interface for Study Site Range. Press to close the screen and end the task, the clear bulletin board is displayed. Press Progress button to display the study set-up progress chart of the current study. CDM Site Enrolment (Data Entry Site Enrolment task) Enrolment may be performed centrally by the CDM or locally delegated to the Investigator. Enrolment is performed in the Data Entry menu. Beside Data Entry Site Enrolment used by CDM described below Data Entry Patient Enrolment and Data Entry Next Patient Enrolment is used to enroll patients in a study. The Data Entry Enrolment Report may be used to state the enrolment status. If the organization applies site enrolment studies but controlled by CDM, rather than by the different site investigators, will use Data Entry Site Enrolment to perform site enrolment. This is practical when testing a Site/Patient Enrolment study in the development environment. Note! The Data Entry menus perform user study and site filtering. On Line PheedIt Study Setup Administration 28 of 77

29 I - icon Selected Study Enrollment Table Print Report Save Information icon for links to this document. Selected study name to perform site range (batch) enrolment for. Note! User site access filtered view! Column Use Site Display Site to allocate enrolment to ID/Name Min Lowest subject ID to enroll, must match allowed min value. I.e. be equal or higher. Max Highest subject ID to enroll, must match allowed max value. I.e. be equal or lower. If less than max allowed are batch enrolled the remaining slack up to and including max may be used for planned for but not anticipated over recruiting of subjects. For situations where recruiting varies between sites. Invokes the study select interface for Study Site Enrolment- task. Use web browser to print current view. Direct link to the Data Entry Enrolment Report for the current study. Press to save defined enrolment. Note! Only continuous site ranges allowed when using site-enrolment task, site enroll positions must be part of the control range but you are not required to utilize the full width of the control range. Any existing slack may be used to add enrolment at a later stage in the study process. Study Module Management (e) As the Study Definer the Study Module Management tasks is where you spends most of your time. In study module management you perform tasks like: On Line PheedIt Study Setup Administration 29 of 77

30 Add Study Module from Library into the study at hand, you will also select module variables to use. Define use of module (active or not) as well as define default module order of use Edit study level module use of defined Library variables Edit study level module variable attributes o Set variable parameters o Set variable range validation parameters o Set variable format use o Edit pre-filled list texts o Set lookup clinical dictionary version for coding purposes Preview data entry screen, with functionality but no save Edit entry screen layout Define use of module variable validation (MVV) checks Delete a study module in development and education environment. Studies that have data inserted into them cannot be deleted to minimize loss of data entered. You perform the tasks above to configure the Library recourse copies to the needs of the individual study at hand. The Study Module Management Interface changes as you use the buttons available. Clicking on the table header sorts the table order based on the variable that has been clicked on. When you start with a new study and have initiated the study (a-task), entered at least one named study visit (b-task) and visit Study Module Management the interface will display as follows: Select study Close Select study where you need to assign site. (List restricted to Site/Patient[SP] defined studies) Note! The interface filters on user study AND site access grants. Close/Cancel step On Line PheedIt Study Setup Administration 30 of 77

31 Next Task Step Press Next task Step -button to continue to the include site selection screen. Yes you are required to select a study. I - icon Modules available for Study Delete Module Column Active Column Information icon for links to this document. Selected study name. Modules can be removed from a study in development and education environment if no data has been entered into them and module is not active in study. Patient information and patient verification not subject to this feature. List available named Modules in the DE Order specified and saved. By default two modules are provided (Patient Information and Patient Verification) Ticked tick boxes indicate that the module is active in the study at hand. A module can be activated/deactivated. An active module will appear in the module selection list during data entry. A deactivated module will NOT appear in the module selection list. A deactivated module is NOT deleted in any way and if data exist, data will not be lost, but will be hidden from data On Line PheedIt Study Setup Administration 31 of 77

32 entry! Adjust module Column Adjust attributes Column Preview DE Screen Column Adjust layout Column Adjust Validation Column Add Study Module Update Study Modules Progress Close Note: A deactivated module will not be exported using the export procedure in PheedIt! This column provides space for an Edit Module task button. When available you use this button to adjust the use of variables for the module row at hand. This column provides space for an Attributes task button. When available you use this button to adjust the use of variables for the module row at hand. Here you find the DE Screen task button, press this button for a module and the data entry preview screen will display the module. The entry screen is shown in a table cell grid. Entry fields, selection lists and dictionary coding will work, data entered cannot be saved. Here you find the DE Screen task button, press this button for a module and the data entry preview screen will display the module. Here you find the Module Validation task button for modules which have module variable validation checks defined. Press this button for a module and the Study Module Validation Check Management screen will display. The interface will allow settings of when checks are active. Press to return to the study selection screen. Press to open the module selection screen. Use this button to add modules to be used in the study. Saves/updates study module order assignments. Press Progress button to display the study set-up progress chart of the current study. Press to close the screen and end the study module management task, the clear bulletin board is displayed. On Line PheedIt Study Setup Administration 32 of 77

33 Add Module to Study I - icon Current Selected Study Select Module Next Information icon for links to this document. Name of currently selected study Select module to be added in list of modules defined in Library. When a module is included in the study, it will disappear from this list. Press to include selected module into study. The variable selection screen will appear. If you select and proceed the task by pressing the Next-button The Edit Module interface opens in -mode. The interface contains different editable fields depending of if module was defined as repeating or Non-repeating, lets start with: On Line PheedIt Study Setup Administration 33 of 77

34 Normal-type, non repeat module: I - icon Subtitles No. of repeats Study Module Specification. You are performing a Add Module task. If the task is completed you will add the selected module to study at hand. Below are discussed what actions you may perform by changing default Library settings for the module at hand. Note! Current module is of type Normal Non-repeating, repeating type module is discussed in next section. Information icon for links to this document. Study at hand Type of study Selected module at hand (SAS dataset name) Module Descriptive name Repeated Module No When module is of repeating type this is an entry field (Se next section) Else presents an non-editable 0 (zero) On Line PheedIt Study Setup Administration 34 of 77

35 Enable Multiple Entry Screens Current Entry Screen description table Selection list-box. By default modules are defined not to enabled to be copied during data entry default is No. If you enable copy in data entry, it will be possible to create a sequence of entry screen copies differentiated by their entry page number. Usable in situations where you need to provide possibility to enter a varying number of entry pages per subject. Using the following table: All Active Library-defined variables are presented. The order the variables are presented reflect the Library Variable management defined order. Study definer now need to define the following prior to adding module to study design. Study Module Study Module Create Study Module Which queries (variables) are to be Included in study data entry interface? Is the default displayed variable data entry order acceptable? The Variable DE-Order, decide now the order as it will not be possible to change without consequences! See amendment changes below. Make your choice carefully, and in this interface. This optional use field may be used to provide data entry with information at top of entry screen This optional use field may be used to provide data entry with information at bottom of entry screen Press button to close and end the include module task and return to module selection screen. No module will be added and entries/choices made will be lost. Press Create Study Module button to add module as specified to the study. On Line PheedIt Study Setup Administration 35 of 77

36 Normal-type, repeat module: I - icon Subtitles No. of repeats Enable Multiple Entry Screens Study Module Specification. You are performing a Add Module task. If the task is completed you will add the selected module to study at hand. Below are discussed what actions you may perform by changing default Library settings for the module at hand. Note! Current module is of type Normal Non-repeating, repeating type module is discussed in next section. Information icon for links to this document. Study at hand Type of study Selected module at hand (SAS dataset name) Module Descriptive name Repeated Module Yes When module is of repeating type this is an entry field You may adjust at study level the number of repeating entry fields to display per entry screen. The default value is the value proposed by the Librarian design. Minimum number of repeats is 2. Selection list-box. By default modules are defined not to enabled to be copied during data entry default is No. If you enable copy in data entry, it will be possible to create a sequence of entry screen copies differentiated by their entry page number. Usable in situations where you need to provide possibility to enter a varying number of entry pages per subject. Enabling multiple entry screens is appropriate for AE and CM module categories. Current Using the following table: Entry Screen description On Line PheedIt Study Setup Administration 36 of 77

37 table All Active Library-defined variables are presented. The order the variables are presented reflect the Library Variable management defined order. Study definer now need to define the following prior to adding module to study design. Which queries (variables) are to be Included in study data entry interface? Is the default displayed variable data entry order acceptable? Clinical Dictionary Coded variables: DE Order Number 9 is a example representing variable that will carry clinical dictionary look-up values. Note gray background and variable name in the Type-column. Also note the Variable name stated is present as DE Order Number 3, and the Variable named has gray background, these variables are related and have a relation. Do not break the relation! Either both appear in entry screen or only the (Red) variable. De-including a LDic type variable will naturally prohibit coding, similarly including the LDic variable and de-including the referenced (Ref) variable will prohibit coding. Coding is normally performed by another staff category, usually not site data entry staff. Study Module Study Module Create Study Module Make your choice carefully, and in this interface. This optional use field may be used to provide data entry with information at top of entry screen This optional use field may be used to provide data entry with information at bottom of entry screen Press button to close and end the include module task and return to module selection screen. No module will be added and entries/choices made will be lost. Press Create Study Module button to add module as specified to the study. Clinical dictionary look-up variables may also be used in non-repeating module definitions. On Line PheedIt Study Setup Administration 37 of 77

38 I - icon Study name Double data entry Module Module name Module repeated No. of repeats Information icon for links to this document. Selected study name. Status of double data entry use for the study at hand Module at hand. Module descriptive name States if module at hand is repeated. The number of repeats may be adjusted at study level. 0 indicates module is not repeated. Default number of repeats inherited from Library. On Line PheedIt Study Setup Administration 38 of 77

39 Current Entry Screen description table Using the following table: All Active Library-defined variables are presented. The order the variables are presented reflect the Library Variable management defined order. Study definer now need to define the following prior to adding module to study design. Which queries (variables) are to be Included in study data entry interface? Is the default displayed variable data entry order acceptable? Clinical Dictionary Coded variables: DE Order Number 9 is a example representing variable that will carry clinical dictionary look-up values. Note gray background and variable name in the Type-column. Also note the Variable name stated is present as DE Order Number 3, and the Variable named has gray background, these variables are related and have a relation. Do not break the relation! Either both appear in entry screen or only the (Red) variable. De-including a LDic type variable will naturally prohibit coding, similarly including the LDic variable and de-including the referenced (Ref) variable will prohibit coding. Coding is normally performed by another staff category, usually not site data entry staff. Variable Column Type Column Label Column Include Column Make your choice carefully, and in this interface. Name of variable. Note! Variable Verbatim is referenced indicated by [Ref.] by the LDic-type variable Clin_dictionary, their relationship is also indicated by the gray background color. As these variables have a relation they must both be included to enable coding. Type of variable as defined. Note! Variable type LDic must contain the name of the reference variable (Verbatim in this sample). If this is not present the Librarian has to reassign the relationship. Variable label as defined in Library. Perform the task to include/exclude variable from use in study by ticking the checkbox. A variable can be included/de-included. An included variable will appear during data entry and will be present in the SAS dataset created to hold collected data. De-included variable will NOT appear in the data entry screen generated and variable will not be present in SAS dataset defined by the design chosen. On Line PheedIt Study Setup Administration 39 of 77

40 Edit mode actions like de-including a variable will result in recreating the data interface layout (may require subsequent layout modifications). A previously included variable where data has been entered that are de-included will have the following result: data entry screen is redefined and the variable is not present. The associated SAS-dataset is also redesigned, at first a SAS dataset generation dataset is created, preserving all entered data, then a new SAS dataset is created, de-included variables no longer exist thus you may not view-browse-edit such entries, they are visible in audit trail reports. Thus hidden from data entry screens! Note 1: If you Include the de-included variable, a new generation dataset will be generated, the variable will appear in entry screens (may require subsequent layout modifications), But this variable will not re-establish contact to any previously entered data via the interface. DE Order Column Study module header text Study module footer text Create Study Module Note 1: A de-included variable will not be exported using the export procedure in PheedIt! Here you define the default data entry order for the variables in the module. The default data entry screen will be based on this order. Order is inherited from Library variable management. Enter text to be displayed as data entry screen header. I.E. Important entry information for this entry screen. Enter text to be displayed as data entry screen footer. I.E. Important entry information for this entry screen. Press to return to the study selection screen. Saves/updates study module assignments in the current study. On Line PheedIt Study Setup Administration 40 of 77

41 Progress statements Edit Added module Forward to Study Module management (SMM) The study module build process is reported. Press Edit Added Module -button to return to Study Module Specification for the module at hand just added to study. Press Next to proceed to Study Module Management for the study at hand. Another module was added from Library, and now the Study Module management looks like below. This time all columns have all button types present. The module Test_Normal has module variable validation rules defined. On Line PheedIt Study Setup Administration 41 of 77

42 I - icon Progress statements Note! Adjust Validation column Add Study Module Update Study Modules Progress Close Information icon for links to this document. The study module build process is reported. If an entry screen (module) has been defined with MVV checks a button will pop up in this column. Further the background of the cell may have one of three background colors: red indicates that you have not used the button (action required), yellow indicate that the MVV rule have been updated by the Librarian and you need to update the validation setting (as needed). If the background is normal gray then no immediate action is requested buy the system. Press to return to Study Module Management for the study at hand. Press to open the module selection screen. Use this button to add modules to be used in the study. Saves/updates study module order assignments. Press Progress button to display the study set-up progress chart of the current study. Press to close the screen and end the study module management task, the clear bulletin board is displayed. Manage Module in Study To manage module behavior in the study you have up to five buttons to use. The use is discussed below. On Line PheedIt Study Setup Administration 42 of 77

43 Edit Module To edit a module definition on study level, this must be based on amendment to the primarily made design performed during Add-module task. Changes may have little or large consequences and may impact on access to stored data. Use education environment to familiarize yourself with the consequences of changing Module using the Edit Module-button. Primarily the Edit Module button is used only when the study designer need to redefine entry screens (modules) included in the study. When you need to change the module study use specification; change use of variables and to change variable order in the entry screen. The Librarian may have edited the Library definition of the module, using the edit module button you may chose to incorporate changes made. Adding or increasing has little impact and consequences while removing has implications on data entry interface layout and more important implication on access to entered data. This is described below. Edit Module Update Variables Modifications (amendments) might be required of the library variable specifications. These modifications need to be applied by the Librarian role. When those changes are made after the module, (which contains the relevant variables) has already been added to the study then it will be necessary for the Study Definer to implement the update process of those specific variables to transfer the library update. Small changes to variable attributes such as the variable length and label that have been made in Library are easily transferred to the variables in Study Module Management by clicking the Update Study Module button in Edit Module for the correct module. Note: In case of changing variable length, PheedIt only allows for the stored length to be increased and not decreased. If there is a need to limit the variable length for layout purposes, then please read the Attribute section of Study Module Management. However, if a critical variable setting is changed such as the type of the variable then the updating process will be different. In order to transfer such a big library update (The SAS dataset representation need to be redefined) to the relevant variable in Study Module Management the variable update process must be performed like this: exclude the relevant variables in Edit Module (in Study Setup Study Module Management) for the relevant study and click the button Update Study Module then go back and include them before clicking on the button Update Study Module again. The modified specifications of the variable will now have been updated. A new SAS dataset defined, and a generation dataset created that hold all entered data if any. Performing this type of action will result in breaking the access to stored data, however stored data is preserved but by definition the access is broken by design. It is possible to recover and reload data using the Import data task process described separately. On Line PheedIt Study Setup Administration 43 of 77

44 I - icon Sub s Table Indicates you are about to change an existing possible used (data entry performed) module. Performing changes will have implications, these are discussed below. Information icon for links to this document. Study and Module information. Module variable content table: Variables defined and variable type and label Checkbox to decide if variable should be used (included) on study level and the data entry order (editable only when adding variable first time, to change order variable need to be deselected) The Variable DE-Order, as indicated by gray background may not be changed using the Edit Module - interface! Need change use the SMM DE Screen On Line PheedIt Study Setup Administration 44 of 77

45 Update Study Modules Editor task to modify entry order! Press to return to Study Module Management for the study at hand. Saves/updates study module order assignments. And generates a default layout based on included variables. The Edit Module button display all variables included in the study from the selected module. In the sample above note the LDic type reference between the variable Clin_Dictionary and Verbatim, identified also with the gray background and the text VERBATIM in the type column. LDic variable type collects information from a clinical dictionary, imported and made available for look-up within PheedIt. The VERBATIM variable is intended to hold the text containing the word to be looked for in the dictionary. Note! If you have included a module and variables and proceeded and released the study for data entry and have performed data entry, and then at this late stage decide to change the variable layout regarding order of the entry fields the following rules exist: If you have the right variables in module and it is the edit entry order you need to change, use the layout screen editor to change to the desired order. Inform the librarian to discuss which default order should be valid in the future. If you need to remove a variable as an amendment request, uncheck the variable use in the Study Module Specification and update. This will create a new generation SAS dataset with suffix #00n that contain entries made using the unchanged layout while the module will contain only the active variables. Thus the data entry screen looses contact with content of dropped variables. If you have an amendment that requires insertion of an additional variable not present in the module library template, your Librarian needs to update the module variable definition with the desired variable specification. After that visit Study Setup Study Module Management Edit Module and add (include) the new variable to the study entry screen. This will create a new generation SAS dataset with suffix #00n that contain the previous layout while the module will contain the active variables. The newly added variable will by default be added to the bottom of the entry screen layout. Thus you might require using the screen layout editor to generate the desired entry layout. Note! If you first remove a module variable for which data entry has been performed and then later add the variable specification back. The data entry interface will NOT be able to reach the data entered prior to variable entry screen removal. The audit trail will be able to do this trick. Thus be aware, or you might need to reenter data! Change Entry order of variables To enable changing data entry order to modify entry order use the Layout Screen Editor!. Sample changing entry order of the added module above to a new desired order: On Line PheedIt Study Setup Administration 45 of 77

46 This is a change not to be performed using SMM Edit Module if data has been entered. If the order of variable querying is needed/requested and the variable order was saved as presented above in the Study Module Specification [Mode: Edit Module] as displayed above use the SMM DE Screen Editor - task to start the Layout Screen Editor to change where variables are positioned on entry screen and thus the order of data entry! Change storage length of a variable If the storage field length need to be changed to accommodate data entered. You need to increase the length allocated to store the variable query answer. (Only increase of storage length is available!) o 1) Contact the Librarian role to change the variable definition of storage length o 2) Do not remove current variable definition from module! o 3) Request that the Librarian confirms variable attribute redefine and increase the variable storage length in the Library - Variable definition - task o 4) Visit Study Setup Study Module Management Edit Module and just save using ( -button), study level module definitions are updated, the SAS dataset updated and data maintained, In this case NO #00n generation dataset is defined as no change is made to the dataset layout. All data is preserved and accessible in the data entry interface. o 5) Check module Attributes for the updated variable, you may also request changing the visible part of the entry field used to edit the variable where storage length was increased. o 6) Confirm interface changes using -button Change Module Included Variables Considerations Edit mode actions like de-including a variable will result in recreating the data interface layout (may require subsequent layout modifications). A previously included variable where data has been entered that are de-included will have the following result: data entry screen is redefined and the variable is not present. The associated SAS-dataset is also redesigned, at first a SAS dataset generation dataset is created, preserving all entered data, then a new SAS dataset is created, de-included variables no longer exist thus you may not view-browse-edit such entries, they are visible in audit trail reports. Thus hidden from data entry screens! On Line PheedIt Study Setup Administration 46 of 77

47 Note 1: If you Include the de-included variable, a new generation dataset will be generated, the variable will appear in entry screens (may require subsequent layout modifications), But this variable will not reestablish contact to any previously entered data via the interface. Note 2: A de-included variable will not be exported using the export procedure in PheedIt! Attributes The Attributes button is used when you need to change the variable attributes; Parameters like prompt, entry field length, fields that have long storage lengths and short entry field will scroll and thus display only a portion of its content, Validation rules like required and variable range validation values, Adjust the use of format items linked to the variable, Populate/edit pre-filled lists, Manage study level change of coding dictionary release. I - icon Information icon for links to this document. Study Name Selected study name. Module Name Selected module name. Variable Variables available and active are listed in this column. Column Type Variable type is stated. Column Label Variable label is stated. Column Attributes All variables have parameters and validation attributes associated. On Line PheedIt Study Setup Administration 47 of 77

48 Parameters Validation Format Pre-Fill (Not shown above. Applicable for repeated modules) LDic (Format, Pre-Fill, LDic etc) Via this button you reach an interface to set variable label and prompt to a study local value. You may also adjust the length of the entry field. Via this button you reach an interface to set variable required flag and range values. Via this button you reach an interface to set variable format values active in the study at hand. If additional values are required the Librarian is needed to extend the format definition. Via this button you reach an interface to set pre-filled variable values. Look-up dictionaries mostly come in distribution versions with release dates as the dictionary content evolves over time. Using this interface you may assign the use of a distinct version in your study. The interface will also manage change of version. Press to return to Study Module Management. Preview DE Screen The DE Screen button is used when you need to preview the data entry screen. Use the preview screen to determine data entry layout. Use the preview to test data entry; save of entered data is not available. The preview screen differs from the data entry screen in that the table cell borders are visible as an aid during layout work. The DE Preview screen looks and acts like the DE entry screen in Data Entry. The screen below is divided into three parts: The top part mimicking the entry screen with header rows stating a nonexistent sample patient. Middle part, with data entry screen as it will look like at data entry, except that the table borders are visible in Preview mode. The gray table borders will not be visible at data entry. At bottom is buttons displayed that are proper for the Preview environment. In data entry other buttons are displayed proper for that environment. On Line PheedIt Study Setup Administration 48 of 77

49 Selected Study Patient no.: Visit: Entry page no. Entry screen layout LDic Screen name for Module, descriptive name, stating data entry mode, in this case CRF-Preview. Selected study name Note! During study definition the Patient no: prompt text may be assigned to another text like Subject no. etc. Visit 999. Normally name of visit as defined in Define Study Visits. 99. Every data entry page may be duplicated in data entry if needed, the first is numbered 1 the next 2 etc. The entry screen layout visible as prompt texts and entry fields in a layout grid of cells. In this sample screen a delimiter in red has been added using the layout editor as well as texts. Note that the dictionary coding variables have not been appropriately adjusted. The time value entry field has been defined required thus it is preceded with the character chosen to visualize the requirement. The - icon will appear in data entry if the data entry role has this coding possibility granted. Pressing the icon will open a dictionary lookup window. Sample coding will work in preview. The two fields to the right of the icon are not editable by data entry, these fields only take values from the coding dictionary. Look-up dictionaries mostly come in distribution versions with release dates On Line PheedIt Study Setup Administration 49 of 77

50 I - icon DE Screen Editor as the dictionary content evolves over time. Using this interface you may assign the use of a distinct version in your study. The interface will also manage change of version. Press to return to Study Module Management. Information icon for links to this document. Press this button to open the Screen Layout Editor, where you may manipulate the layout presented in the preview. Note! The use of the layout screen editor is described in a separate document. DE Screen Editor The DE Screen Editor button is used when you need to adjust the entry screen layout. The screen layout editor allows changes to the default data entry screen. The possibilities of change are described in a separate document, available in the DE Screen Editor. The DE Screen Editor is a JAVA Applet program and this functionality is intended for internal use only, by the Study Definer. Use thus requires the ability to run JAVA runtime on the client computer for the role performing these layout tasks. The JAVA-runtime engine is updated periodically. If You update the runtime environment it is not guaranteed that the new runtime environment allow executing the applet. If this happens You need to block use of the new runtime environment (workaround), this is accomplished in the JAVA runtime console. Also inform SAS institute providing a screenshot of the console log output. On Line PheedIt Study Setup Administration 50 of 77

51 Web-page JAVA Applet grid window (yellow background) A web-page header is displaying the Layout Screen Editor title and state module and study at hand. Yellow area above represent the applet JAVA window. Following the JAVA window is a link to html-characters and the standard PheedIt interface footer. Screen presented by the layout editor, containing the prompts and entry field objects of the module at hand. The grid represents the rows and columns. The leftmost column is here used to push all items to the right. The layout editor provides tools available as a right click tools window. Using these tools you may add and change layout properties. Objects presented in the cells may be objects owned by PheedIt module design or objects defined in the layout editor. Details on the use of the screen layout editor is presented in a separate document. Also available behind the - button Version no: 2.0 is the appropriate version for PheedIt Press this button to save layout changes made. Press this button to undo layout changes made and return to saved state. Press this button to view the layout screen editor manual in a separate window. Press this button to return to Study Module Management. Note! A separate document describes the use of the Screen Layout Editor. On Line PheedIt Study Setup Administration 51 of 77

52 Module Validation The Module Validation button is used when you adjust the use of Library Module Variable Validation (MVV) checks defined for the module. I - icon Current Study Current module Validation check name Column Information icon for links to this document. Name of selected study Name of current module All named Module Variable Validation checks for the module at hand is listed. Error description The stored error description of the check Column Cross modules Statement stating if more than one module is in use by the check. Active in batch Tick the checkbox if you decide that the check should evaluate entered data when executing AVC/batch. Active online Tick the checkbox if you decide that the check should evaluate entered data online during data entry. If this checkbox is active, data entry may not enter data that collide with check logic. Erroneous entries are not saved, i.e. you may not receive statistics on errors made. Cross Visits Statement stating if more than one visit is in use by the check. Invokes the interface for Study Module Management Save Press to save the study module variable validation settings for the vurrent module. By saving the validation rule is created on study level. You can verify this by generating a report after saves. See menu Data Val. Mgmt. Report on MVV Check. Note! The definition of the MVV check is performed by the Librarian, if the check logic needs change contact the librarian. When the check has been updated or replaced, visit the Module Validation in Study Module On Line PheedIt Study Setup Administration 52 of 77

53 Management again to perform save of the updated/changed check specification on study level. Invokes the study module variable management screen Update Study Modules The Update Study Modules button is used when you save changes made to the default module order or module active status. The button also removes study modules that are checked for deletion. Use the Study Module Management DE Order field to assign the default entry order for the modules in use in the study. Use the Update Study Modules to save order entries and active settings made. The interface changes if modules where checked for deletion and lists all the modules that were deleted if they did not hold any data. If modules where checked for deletion then they will be listed. Invokes the Study Module Management screen On Line PheedIt Study Setup Administration 53 of 77

54 Close Study Module Management The Close button is used to close and leave the Study Module Management tasks. Define Data Entry Book (f) Defining the data entry book is the last of the required actions in the Study Setup task list required to be performed prior to performing data entry tasks (except metadata export). Whenever Define Study Visits (b) or Study Module Management (d) changes occur you need to ensure the Define Data Entry Book attribute settings for the study. The Study Setup Process Progress Chart is handy to follow up on what is required tasks to perform on a study. The task of defining the Data Entry Book is where you visit by visit define use of data entry screens. Define Data Entry Book may be performed using two interfaces, normal and advanced. We strongly recommend the use of the normal interface until the very end of the study setup and testing process cycle. The advanced interface is there to solve one problem only, namely when the order of data entry screens vary between visits. The normal interface will use the module order assigned in the Study Module Management. You pass a point of no return if you use the advanced mode, this mode increase the work load if used to early. Selected study Tick box Use Advanced DEB Definition Close Next Task Step Selected study in list to define entry book for. When at the end of the study define and test cycle, tick this box to enter the advanced interface. In this interface you will be able to adjust for visit level entry screen (module) order requirements. Close/Cancel task Press Next Task Step -button to proceed to the data entry book definition page. On Line PheedIt Study Setup Administration 54 of 77

55 Yes you are required to select a study. Normal I - icon Study name Column Study Module Column to the right of Study Module Cross table of checkboxes Entry mode is shown one of; New or Edit Information icon for links to this document. Selected study name to perform entry book definition on. Name of modules included and active in Study Module Management Name of the visits as defined in Define Study Visits. Check the appropriate checkboxes per visit where you would like the named module to be in use. Create/Update Data Entry Book Note! When in Edit-mode module order of use per visit is presented beside the checkbox. Default order of module use is defined in SMM. Return back to study selection list. Note! If advanced mode was ticked, using this back button will not undo the selection. Press to save checkbox selections made. On Line PheedIt Study Setup Administration 55 of 77

56 Advanced The advanced data entry book administrative task is only recommended to be used if you have the modules in different order at different visits. As this interface requires more detail manipulations we recommend its use to be the last thing to perform when working with defining data entry book. Thus in all studies you should start by using the default non advanced interface. When you switch you will be presented the following interface. It is your responsibility to add numbers using the proper number sequence per column. Zero (0) indicates that the module is not to be used at column visit, any integer will indicate that module will be present in visit and that the visit presentation sequence of the modules may be set individually per visit. Due to that the default data entry book uses the Study Module Management stated module order as the default module order for all visits, this interface is only applicable when different order of module use is required in a per visit fashion. You will not be able to reverse to normal data entry book interface once you checked the advanced mode tick box! I - icon Entry mode is shown one of; New or Edit Information icon for links to this document. On Line PheedIt Study Setup Administration 56 of 77

57 Study name Column Study Module Column to the right of Study Module Cross table of number entries Create/Update Data Entry Book Selected study name to perform entry book definition on. Name of modules included and active in Study Module Management Name of the visits as defined in Define Study Visits. Enter 0 (zero) in all entry boxes where you do not need the module to be in use. Enter per visit the order by which you would like the module, repeat visit by visit. Note! Check that module order is unique per visit. Return back to study selection list. Note! If advanced mode was ticked, using this back button will not undo the selection. Press to save checkbox selections made. Save Confirmation Clear Progress Invokes the study select interface for Define Data Entry Book Press to clear the screen and end the task, the clear bulletin board is displayed. Press Progress button to display the study set-up progress chart of the current study. Set User Study Role (g) For studies with the freeze and visibility feature enabled the users who have access to the study must belong to a Role in the study. The role that users are member of will affect the visibility and freezing of data entry depending on the role settings. By default there are 8 different roles that a user can be a member of. The default role for all users that have access to a study is No Role ( none ). The role for the users can be changed to: No Role (default) Principal Investigator Investigator Specialist Data Entry On Line PheedIt Study Setup Administration 57 of 77

58 Monitor CDM Data Entry CDM These roles have different type of access and rights to data entry and freeze of entered data which is illustrated by the table below. Study Role Data Entry Edit Freeze Principal Investigator Yes Yes Investigator Yes Yes Data Entry Yes No Monitor No Yes Specialist Yes No CDM No Yes CDM Data Entry Yes No No Role No (+ No Browse) No By default members of the role Monitor and CDM are not able to enter or edit entered study data in PheedIt. The Freeze functionality is only accessible for the roles Principal investigator, Investigator, Monitor and CDM. Users with the default none role has neither data entry edit nor freeze functionality rights. CDM Data Entry role is a special case intended to be used as follows. A dedicated entry screen (module) is created to capture information per subject intended NOT to be public to other users (blinded), further it is designed that it is the CDM that will enter data into this entry screen. Thus the CDM must toggle his/her study role between CDM and CDM Data Entry to be able to perform the data entry. Finally the visibility function must be activated for this module enabling the possibility to hide the entry screen for other user roles as appropriate. The role Specialist is intended for a similar purpose where the data entry is intended to be carried out by a medical specialist, but information is intended to be blinded to Investigator etc. Specialist role thus also intended to be used together with visibility settings. Select the study for granting study roles. Note: Only studies with the freeze and visibility feature enabled are listed in the study list. On Line PheedIt Study Setup Administration 58 of 77

59 Select study Close Next Task Step Select study where you need to grant study roles Close/Cancel task. Press Next Task Step -button to continue to Grant study roles for users with access to the selected study. Yes you are required to select a study to work with. The users that have access to the selected study are listed in the users column. The roles that can be assigned the users are all displayed and can be granted the listed users. In the screen shot below the selected study has 3 users who have access rights to the selected study. Select the roles that you like to assign to the listed users and click on the save button. Select study User Roles Next Select study where you need to grant study roles All users that have access to the selected study. Roles that can be granted a specific user. Press the save button to save the selected roles for the selected users. Press the back button to get back to the study selection screen On Line PheedIt Study Setup Administration 59 of 77

60 Clear Progress Invokes the study select interface for Set user study roles. Press to close the screen and end the task, the clear bulletin board is displayed. Press Progress button to display the study set-up progress chart of the current study. The use of Study Role settings is also discussed in a separate document: Study_Role,_Visibility,_Freeze_Administration_Online.pdf Set Visibility by Role (f) For studies with the freeze and visibility feature enabled the users who have access to the study must belong to a Role in the study to be able to be granted visibility to data entry screens/modules. The visibilities for all users are set by using the Study Setup Set Visibility By Role. By default none of the modules are visible for any of the roles. This step is preformed after that the Role definition has been done for the selected study. As there are 8 different roles (including the none role) that a user can be a member of, the visibility for these roles can be adjusted by this feature. Note: Only studies with the freeze and visibility feature enabled are listed in the study list. Select study Close Next Task Step Select study that you need to grant visibility for roles Close/Cancel step. Press Next Task Step -button to continue to Grant visibility to study modules for users with access to the selected study. Yes you are required to select study to work with. On Line PheedIt Study Setup Administration 60 of 77

61 Visits and modules that are included in the Study Setup - Define Data Entry Book are listed in the Manage/Define Role Access interface. Via this interface the visibility of the different modules in different visits can be set for the different roles. In the interface below the Investigator Role is defined to have access only to modules in visit 1. Click on the save button to save the selected visibility settings made for the different roles. Clear Progress Invokes the Manage/Define- PheedIt Role Access. Press to close the screen and end the task, the clear bulletin board is displayed. Press Progress button to display the study set-up progress chart of the current study. A user with the Investigator Role will after this action have the following visibility in the DEB-Tree. The visibility will also affect all other data entry paths as well. On Line PheedIt Study Setup Administration 61 of 77

62 The use of Visibility settings is also discussed in a separate document: Study_Role,_Visibility,_Freeze_Administration_Online.pdf Authentication Signature (i) With the authentication signature enabled on the study level the users that is performing data entry and data freeze must authenticate themselves in the entry interface in order to be able to proceed to the next step. Identifying the user by authenticating them will improve the security and reliability of entered and frozen data in studies. Select study Close Next Task Step Select study that you need to administrate authentication settings for roles Close/Cancel step. Press Next Task Step -button to continue to Grant authentication settings to study modules for users with access to the selected study. On Line PheedIt Study Setup Administration 62 of 77

63 Yes you are required to select study to work with. A complete description of the functionality is available in the Authentication Signature online documentation. Export Study Metadata (j) Exporting Study Metadata will capture current Study Library Metadata and save them in a study database subfolder. This action is also used to determine if the study setup process cycle is completed and the study may be released for data entry. Captured Study Metadata is stored in the study database folder, a separate time stamped version of study metadata will be created every time you save study metadata. Select study Close Next Task Step Select study that where Metadata need to be saved Close/Cancel step. Press Next Task Step -button to continue to save study metadata. Yes you are required to select study to work with. On Line PheedIt Study Setup Administration 63 of 77

64 Sub title Print Table Clear Selected study name. You may print the interface using this button. Reports Study Library metadata saved and where. Invokes the Study Selection interface. Press to close the screen and end the task, the clear bulletin board is displayed. Saving study metadata as the last step in the Study Process Progress will release study and enable Data Entry actions. Some Site/Patient enrolment studies will require subject enrolment prior to releasing entry screens for data entry actions. Define DE Study Password Use this interface to change the confirmation password required in data entry when the Administration System Configuration Password Confirmation Mode is set to on. This is typically a CDM role action if in use. On Line PheedIt Study Setup Administration 64 of 77

65 Selected study Next Select study in list. Press to accept selected study and move to the next interface. Selected Study NEW Password Confirm NEW Password Save Selected study name. Enter NEW password, use 7 to 20 characters Re-Enter NEW password Press Save to execute your selection. Interface will complain if password is less than 7 characters of length. On Line PheedIt Study Setup Administration 65 of 77

66 Selected Study Close Selected study name and the Password save confirmation. Invokes the study select screen for Define Module DE Confirmation Password Press to close the screen and end the task, the clear bulletin board is displayed. This task is further described in a separate document. Study Activate/Deactivate It is possible to inactivate a study that has been initiated. Inactivated studies are removed (hidden) from all the environment interfaces including Library Define Study Metadata the study is hidden not removed, thus you will not be able to create a new study using a name in use by an inactivated study. Using this menu you may toggle the Study status back to Active, and the study will be accessible in environment interfaces. Sub title Selected study name. On Line PheedIt Study Setup Administration 66 of 77

67 Print Table Close Next Task Step You may print the interface using this button. Reports Study Library metadata saved and where. Close/Cancel task. Press Next Task Step -button to continue to the activate/deactivate interface. Yes you are required to select study to work with. This task is further described in a separate document. Define FDE Prompt Char Use this menu to assign the character symbol to indicate required field, the selected character will be displayed for all variables with the force data entry attribute set. Select study Close Next Task Step Select study name where the required (force data entry) character is to be set. Close/Cancel task. Press Next Task Step -button to continue to the next interface. On Line PheedIt Study Setup Administration 67 of 77

68 Yes you are required to select study to work with. Change to Select one of the characters: in the selection list. Select one of the character colors in the selection list: Save Select one of the display character sizes in the list: Press Save to execute your selection. On Line PheedIt Study Setup Administration 68 of 77