PLATA Data Management User Manual. Version: 1.0

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2 1. Table of Contents 1. Access to the PLATA Data Management environment Web address and login procedure Features of the ALEA Data Management module Patient Grid Layouts Add new patients, navigation, and form completion Saving and submitting forms Data validation and Audit Trails Queries SDV Annotations Activities Form locking, Set verified, and Sign off Set form verified and/or form locking Form locks and Sign off Monitoring tab User (profile) tab 47 Page 2 of 49

3 1. Access to the PLATA Data Management environment 1.1 Web address and login procedure. This section explains how a user can get access to the ALEA Data Management environment for the PLATA study. The ALEA 4 Data Management environment operates as a Software as Service (SaaS). As a result, users can access the Data Management environment using commonly available web browsers (i.e. Internet Explorer 7.0 and higher, Mozilla FireFox, Google Chrome, Safari (Apple), and Android 4.0 and higher. To access the study, select the web address (URL): Press the Enter key. Also consider bookmarking the selected page to quickly return to the web a next time. After selecting the URL/web address of the ALEA Data Management environment, a login screen is displayed (Picture 1.1.1). Picture Login window of ALEA Data Management module. Set your password If accessing the site for the first time, click the link: I forgot my password/ I never logged in before (see Picture above). The screen, shown in Picture is displayed. Page 3 of 49

4 Picture Password request window. Note that ALEA accounts are created on the basis of personal accounts. Personal in this context refers to the fact that passwords are kept private and are not known to the ALEA service provider. The addresses used to access the Data Management environment are those recorded in the Persons & Institutes spreadsheet. Enter the address which was used to create the ALEA account and press the button Send request. The message shown in Picture is displayed. Picture Password request screen with a text message notifying an has been sent to the specified address. An is sent to the submitted address. This contains the following text: Click the link in the Password change request e- mail. This will redirected to a page on which a password can be created (see Picture 1.1.4). Page 4 of 49

5 Important: make sure you click the link within 30 minutes after receiving the Password change request . For security reasons, a time frame of 30 minutes after submitting a password change request has been set for allowing users to change their password. Picture Change password for ALEA page. Enter a password with a minimum length of 8 characters and which contains at least one digit (e.g. 1,2,3 ). Enter the password again in the Confirm new password field and press the button Change password. The next window signifies the password was changed successfully (see Picture 1.1.5). Picture Confirmation window stating that the password has been changed (or created). Close the window and go back to the correct web address (see page 4). As Username, use your address. Next, enter the previously established password and press the Login button. Page 5 of 49

6 2. Features of the ALEA Data Management module 2.1 Patient Grid After logging in, the Study menu Tab is displayed by default (Picture 2.1.1). Picture Study information menu (Tab). The Study menu Tab displays general information about the (PLATA) study and includes a graph of the study accrual. The second menu Tab contains the Patient Grid (Picture ). The Patient Grid lists all patients included in the study. Picture Patient grid displaying all patients included in the study. Filtering and sorting can be performed directly on the grid by easy to use drag-and-drop options (explained below). In the top left corner of the display one can select the study (short) name for which one wants to perform data management (see Picture and Picture 2.1.3). If a user has access to more than one study, these are all listed in the drop down list. Page 6 of 49

7 Picture In the top left corner of the Data Management environment a Drop Down list displays the study name. If a user has access to more than one study, these studies are available in the Drop Down list and can be selected from this list. To the right of the Drop Down list with study names there are Menu Tabs of which the Patients overview is selected by default. Picture is a section containing Layout settings, a page refresh button, and a button to open the Export Overview. With the icons: and one can collapse or expand table groups. More information on these functions is given in section of this manual. The settings of a session are stored so when re-entering the Data Management environment, the pre-selected study, as well as the filtering settings, will be as they were during the previous session. Other Tabs available in the Data Management environment include: Queries menu; see section 5 of this manual. SDV menu; see section 6 of this manual. Coding (optional; not described in this manual). Annotations; see section 7 of this manual. Activities menu; see section 7 of this manual. Reports (not described in this manual). Monitor menu; see section 10 of this manual. User Profile menu; see section 11 of this manual The Patients menu Tab, or Patient Grid, allows filtering, grouping-by, and sorting on the list of patients enrolled in the study, which allows for easier search for and access to patients. Page 7 of 49

8 Group-by For example, by dragging-and-dropping the header Institute to the Group-by header, the list of patients will be grouped- by institute (see Picture 2.1.4) Picture By dragging a column header to the header row above, the Patient grid is grouped by that column. Filtering Filtering can be done by using the - icons (see Picture 2.1.5). Page 8 of 49

9 Picture Filtering can be arranged on any column. Sorting Sorting is arranged by clicking the - and icons (which will sort form low to high, or high to low values respectively). Click a header to make these icons available (see Picture 2.1.6). Picture Sorting icon will be displayed after clicking on a column header Layouts Group-by, filtering and sorting selections, which were created to support specific goals and tasks for data managers, study monitors, and Central Data Managers can be stored in so called layouts. To store these, select Layouts just below the study name, at the top left of the page (see Picture 2.1.7). Page 9 of 49

10 Picture Layout menu, where one can select previously defined Patient Menu Layouts and store new ones. Select Save current layout and choose one of the pre-set Layouts. The option at the bottom of the Layout-menu list: Select display columns will open a box containing more column headers (See Picture 2.1.8). Page 10 of 49

11 Picture A field chooser box is displayed after selecting the option Select display columns form the Layout menu. The headers within this Field Chooser box can be inserted into the Patient grid to make more refined selections of the available data. For example, one can insert the header Number of open queries on Forms to the grid to display the forms containing any open queries (see Picture 2.1.9). Picture The column Number of open queries on Forms has been added to the Patient grid. Page 11 of 49

12 A list of all of the available Field Chooser box options is provided in Appendix A (section 12). When the Layout of the Patient Grid is organized with a Group-by action, the selection can be expanded using the icon or collapsed with the icon. To export the information available in the Patient Grid, select the Exports overview button, to the right of the Layout settings menu (Picture ). Picture Position of the Exports overview button of the Data Management environment. An Exports overview is available for all of the default overview menus (tabs), e.g. Patient Grid, Queries, SDV, Activities and Monitor menu. The Exports overview opens in a new browser tab or window and displays the unsorted information which is also displayed in the Overview it was opened from. For instance, opening the Exports overview from the Patient Grid gives the overview shown in Picture Picture Example of an Export Patient overview. The Exports overview offers the data to be exported in the formats shown in Picture This allows the data to be arranged and filtered even further using the available options in, for instance, Microsoft Excel. Picture environment. Exports formats available in the Exports overview(s) of the ALEA Data Management Page 12 of 49

13 Before exporting an overview into one of the available formats, one can filter and arrange the data presented in the overview. This works in a similar fashion as explained in paragraph 2.1 about the Patient Grid. Columns can be arranged, added to or removed from the overviews similarly as it was explained in paragraph Add new patients, navigation, and form completion To register a new patient, click Add new patient at the far right of the page (see Picture ). Picture Just above the Patient Grid, at the far right side, the option Add new patients will present the first form to register (or randomise) a patient for a study. Pressing Add new patient will result in one of two possibilities: If a user (e.g. Research Nurse/Research Nurse) has permissions to enter patient data on behalf of only one investigator/pi, the first ecrf (i.e. Patient enrolment) is automatically displayed. If a user has permissions to enter patient data on behalf of more than one investigator/pi, a pop-up window is displayed first. The pop up window contains the list of clinicians (i.e. PI s), from which the user can select the name on behalf of whom to register a new patient (see Picture 2.2.2). Page 13 of 49

14 Picture Pop-up window from which the clinician should be selected from a Drop Down list, After selecting the responsible PI, the first form (i.e. Patient enrolment) is displayed. The screen is divided in three parts (see Picture on page 13); 1. Left part; initially showing the current date, the name of the PI (clinician), and the (toobe-assigned) patient ID. After Eligibility screening, this side is reserved for navigation through Study Events (Preoperative data, Peri-operative Data, Postoperative, etc.). 2. Mid-section; the ecrf containing the data items to be completed is displayed in the centre of the screen. 3. Right part; this section contains the data management menus, amongst which are Audit Trails and Discrepancies, Queries, and Annotations. Depending on the role and permissions of the user, more menus can be available. More explanations about the available menus in the right part of the ecrf is given in sections 4 (page 22), 5 (page 25), and 6 (page 31) of this manual. Page 14 of 49

15 Picture Example of an open ecrf, which is displayed in the centre of the screen with to the left of it the navigation menu and to the right all available Data Management menus. After pressing the submit button, a Note to File is presented which should be completed first (Picture 2.2.4). Picture Note to File window, which is required to be completed after each submit. One can either enter free text or check the box near no comments. Press OK to confirm. Page 15 of 49

16 The Randomisation service is automatically started after submitting the Eligibility screen. The result of the randomisation (i.e. the allocated treatment arm) can be displayed on the screen as shown in Picture Note: depending on one s role in a study and whether it concerns a blinded study design, the randomisation result can be hidden from view. Picture After submit message containing the randomisation result and patient ID. Close the Eligibility screen form by clicking the Close Registrationform button at the top right of the ecrf (Picture ). Picture Close Registration form positioned at the top right part of the ecrf. This closes the first form of a study, generating the Patient/Subject ID. After closing the Eligibility screen, the Patient Grid is displayed again, showing the last registered patient at the top of the list. To proceed with completing forms for this patient, one should press the Open button in the last column of the Patient Grid (see Picture 2.2.7). Page 16 of 49

17 Picture The last column of the Patient Grid contains the link to the patient dossiers. Pressing the Open button will open this dossier. The - icon next to a given patient displays information about forms, queries and annotations and their status (picture 2.2.8). Picture Patient information window With the open button in the last column of the Patient Grid one can access the Patient dossier. This patient dossier provides access to all completed and to-be-completed ecrf s (Picture ). Page 17 of 49

18 Picture Open patient dossier with a the left the navigation tree, showing all relevant forms for these visits. On the right, the legend for form status icons is shown. The -icon in front of each open form button provides information about a form status. The various form status icons are explained in the Legend (which for the purpose of this manual was positioned next to the navigation pane). This legend is available at the bottom of the page (see Picture above). The forms/ecrf s within each visit are displayed by first expanding the visit. Expand a visit by clicking the plus-sign in front of the visit name in the navigation tree: Some visits are repeating visits (e.g. Unscheduled visits). To add another Unscheduled visit, expand the section (using the -icon) and click Add new (see Picture ). Page 18 of 49

19 Picture Example of a repeating visit Expanding a visit folder, gives access to the related forms/ecrf s (see Picture ). Picture Example of a repeating Study Event with one event added Another feature, which is also visible in Picture , is the pin button (at the top right of the navigation pane). With the pin is pointing downward, clicking the Open form button will open the form in the centre of the screen, with the navigation pane at the left and the section for Audit Trail entries, Queries, Annotations etc. to the right (see Picture ). Picture Downwards facing pin button, to open the forms including the navigation pane to access the entire patient dossier Page 19 of 49

20 With the pin pointing to the left, the navigation pane will be hidden from view when opening the form. This allows for more space to display the right part of the screen with the Audit Trail entries, Queries, Annotations etc. (Picture ). Picture navigation pane. Opening a form with the pin button facing to the left, will display the form without the The screen can be adjusted to conserve space for the task performed at a given moment. By clicking the separator arrow buttons of the panel separators (see Picture ) one can hide a panel, giving room to the remaining panel(s) on the screen. Picture Separator arrow buttons can be used to hide and/or display the screens. Page 20 of 49

21 3. Saving and submitting forms This section describes some for the actions Research Nurses can perform. Its aim is to provide a better understanding of these actions and differences between them. Saving Research Nurses can save data entered on a form at any moment during the form completion process by clicking the Save button at the bottom of the page. Saving form data can be done even if the data contains discrepancies: no Audit Trail entries need to be resolved before saving. Submitting Before submitting a form, all Audit Trail entries need to be resolved first. A submitted form therefore conveys the message it has been completed with all available information at that point in time of the patient s study progress. If needed, forms can be modified at any point in time until the forms get locked and/or verified. After pressing the Submit button, a pop up window is displayed in which a note-to-file is requested (Picture 3.1). Picture 3.1. Note to File window. If no Note-to-files apply, one can check the No comments box. Only after either a message in the Note-to-file text box has been written, or the No comments check box has been ticked, the OK button becomes available. A message, like the one shown in Picture 3.2, indicates the form has been submitted successfully. Page 21 of 49

22 Picture 3.2. Confirmation window after submitting a form Press Ok to continue Note-to-File messages can be found under the last Tab of the Audit Trail and Discrepancies menu (See Picture 3.3). Picture 3.3. Example of a Note to File message, which can be found under the Audit trail and discrepancies menu. 4. Data validation and Audit Trails Each data entry field can contain one or more data validations (i.e. Edit checks). These validations verify whether entered data complies with pre-specified rules and conditions. Data validations are indicated by red dotted lines around the data entry fields. Each discrepancy is also displayed in The Audit Trail and discrepancies section, which is one of the available menus located at the right segment of a form opened within the Data Management environment (see Picture 4.1). Page 22 of 49

23 Picture 4.1. The Audit tail and discrepancies menu of an ecrf is available on the right segment of the screen. The Audit Trail and discrepancies menu consists of 4 tabs: Current Data item, All data items, Audit trail log, and Notes to file (see also Picture 3.3 on page 21). The Current data item menu contains the data validation message(s) for one of the data items on the form; the data item having the focus, in other words the data item in which the cursor is present. The All data items menu displays all Audit Trail entries present on the form. Each data validation message, displayed in a red field, provides an explanation as to why entered data is regarded not valid. After resolving an Audit Trail entry the message is displayed in a yellow field. After submitting a form with the resolved Audit Trail entries, the messages are stored under the Audittrail log. The Notes-to-File, which are provided during each submit, are stored under the Notes to file tab. Picture 4.2 shows part of an open form with to the right, the All data items Tab of the Audit Trail menu. The menu shows 3 Audit Trail entries, which needs to be resolved (as indicated by the yellow background), 2 reflect changed values (top and bottom one) as compared with the previous submit, and a new discrepancy (middle one). Changed value Audit Trail entries always display both the previous and the newly entered value. Picture 4.2. Example of an open form; the right segment of the screen is reserved for Audi Trail entries, Query management, and annotations. Page 23 of 49

24 To detect to which field an Audit Trail entry is referring, click the in the related field on the ecrf. - icon; the cursor will be set If after entering or selecting a value into a data field a Data Validation message is still displayed in the Audit Trail, an explanation can be added to the Audit Trail entry by selecting the Resolve button. Selecting the Resolve button will display a pop up window. Picture 4.3 is an example of such Audit Trail entry window. Picture 4.3. Resolve options window of an Audit Trail entry. The title of an Audit Trail entry indicates the name of the field to which it relates. The Control name is the label the field has within the data base and is not of importance for data management. The message indicates what action is about to be performed on the data validation error. The data validation message describes what condition has been violated by the value entered in the data field. A reason for overriding the data validation error can be provided by making a selection from a drop down list box: Other If none of the pre-described options for resolving an Audit Trail entry apply, it is possible to select the option Other which will activate the Description field in which any text can be entered. When the option Other is selected, an explanation for overriding the data validation error needs to be entered in this description field in order to activate the submit button. Page 24 of 49

25 Important: the Ok-button will only become available after one of the available reasons for resolving a query has been selected. 5. Queries The Queries menu is one of the available menus for each form opened within the Data Management environment. The queries menu is indicated by a question-mark-icon: In contrast to Audit Trail entries 1, queries are person generated questions regarding entered data, usually from CRA s, Study Monitors or Central Data Managers towards the person responsible for entering the data (e.g. Study Nurse, Research Nurse). Queries can address specific data items on a form as well as general questions for the Research Nurses. The header of a query tells whether the query is one of three query types. 1. Data item related query Query relates to a specific data item on a form 2. Form query Query relates to a specific form 3. Patient query Query to ask a general question to the Research Nurse, responsible for entering the data for one or more patients, on behalf of one or more clinicians/investigators To create a query, one selects the field on the form to which to add the query. Next, open the Query menu and select the desired query type (e.g. data item related, form related, or patient related). Picture 5.1 shows the query menu with the three icons representing the three available query types. 1 Audit trail entries appear in real time after an inbuilt edit check detects a discrepancy between the entered data and (a) pre-specified condition(s). Page 25 of 49

26 Picture 5.1. Query menu with the three icons representing the three available query types. After selecting the Query menu and selecting the Raise query on data item icon, a query popup window is displayed (Picture 5.2.). A subject header as well as the actual query text can be specified below the pre-printed name/label of the data item. Picture 5.2. Example of a Query message specification (pop-up) window for a specific data item. After specifying the query text the OK button becomes active. After confirming the query, it is added to the query menu with the name of the person creating the query, as well as the data and time the query was raised. The red background indicates the query is pending and needs to be resolved and answered by the Research Nurse. Page 26 of 49

27 Picture 5.3. Example of a query message next to the form. All Queries related to forms are listed in the Queries overview of the Data Management environment. This menu is accessed by selecting the Queries Tab, which is right next to the Patients tab (see Picture 5.4). Picture 5.4. Queries overview is visible under the Queries tab. The Query overview displays all Audit Trail queries, SDV queries, and manually entered Queries (entered by CRA s or Monitor). The queries can be filtered by status, type and Source for query. Query status (first column of Query overview, visible in Picture 5.4.). 1. Open queries 2. Replied queries 3. Re-raised queries 4. Closed queries Type of query (second column of Query overview, visible in Picture 5.4.). 1. Data item query Page 27 of 49

28 2. Form query 3. Patient query Source of query (third column of Query overview, visible in Picture 5.4.). 1. Entered queries; the queries created by CRA s and Monitors 2. SDV queries; Query to indicate data item is marked for Source Data Verification 3. Form discrepancies; audit trail entries indicating the value of a data item failed to pass the pre-defined (and pre-programmed) data validation. 4. Form missing data; audit trail entry indicating a data item was submitted without any value where one was required according to the a pre-defined (and pre-programmed) data validation. The query can be by clicking anywhere in the row of that query. The query opens at the right side of the screen. From there it is possible to reply to the query, as well as to access the patient dossier or form to which the query relates. To reply to a query in the Queries overview, click the reply button above the query text (see Picture 5.5) Picture 5.5. Replying to a query directly from within the query overview. It is also possible to reply directly from an open form using the Queries menu to the right of the form when the form has been opened (Picture 5.6). Page 28 of 49

29 Picture 5.6. Example of a pending data item query as it appears next to the form, in the Queries menu A pop up window is displayed in which the reply can be written (see Picture 5.7). Picture 5.7. Example of a reply to a query. There are two options for opening the form which has been queried; either by opening the form within the patient dossier or by merely opening the form directly (see Picture 5.8). Page 29 of 49

30 Picture 5.8. Open query in query overview. Shown are the two options for opening a form (containing the data item) being queried. One can access the form as well as the patient dossier, or one can open a form directly without opening the patient dossier. The latter option is to be preferred for quickly reviewing the form (or data item) to which a query refers. This is because opening an entire patient dossier generally demands more resources from the service and therefore is more time consuming. After replying to a query, the answer is stored under the same subject heading. Date and time, as well as the account name of the Research Nurse are mentioned below the answer (see Pictures 5.9 and 5.10). Picture 5.9. Example of data item query with a reply by a Research Nurse underneath it, as it appears next to the form, in the Queries menu Page 30 of 49

31 Picture Example of a data item query with a reply by a Research Nurse, as it appears within the Queries overview The CRA can then either reply to the answer of the Research Nurse again to make a further inquiry, or close the query if the answer provided was deemed sufficient (see Picture 5.10 above). Another means to add queries is explained in the next section, SDV. 6. SDV The process of Source Data Verification (SDV) is supported within the Data Management environment by providing SDV markings to each data item. The first step to utilize SDV within the Data Management environment is to create a SDV setup. Picture 6.1 shows the SDV definition menu which can be found under the SDV Tab. With this option one could define a SDV plan. Picture 6.1. SDV Tab with SDV set up menu. Page 31 of 49

32 Click Add new setup to define an SDV setup. Picture 6.2. shows a create new (SDV) definition window Picture 6.2. SDV setup definition window. One can opt to include or exclude saved data, verified, signed and/or locked forms. Once created, the SDV setup can be modified. More SDV set ups can be defined per study. Picture 6.3. Example of a SDV set up. Click modify; on overview of all forms and visits will be displayed in the left part of the set up screen. Click on a form name. A representation of the form is displayed in the centre of the screen. Page 32 of 49

33 Picture 6.4. SDV set-up representation of a form (i.e. in- en exclusie criteria). Select a data item and mark it for SDV by using the options provided in the right pane. The option None is selected by default, which indicates no SDV is required for this data item. The option Optional and Required can be used to distinguish between data items for which it should be possible to use SDV, and data items for which it absolutely mandatory to have them source data verified. After selecting either Optional or Required, one can indicate whether SDV is asked for the data item within the current form only, within the same Study event (for instance when the item repeats across repeating forms), or within all Study Events. Once a SDV setup has been defined, an overview can be generated under Study SDV set up (see Picture 6.5.) Important: always click the button Rebuild overview in order to generate the SDV set up using the last study data. Picture 6.5. Rebuild overview creates the SDV overview. Page 33 of 49

34 Selecting a form generates an overview of the data items wit to the left the form as it is displayed for data entry, and to the right an overview of Queries, SDV markings, Coding en Annotations on both the form level as well as the data item (see Picture 6.6.) Picture 6.6. Selected Data items will be indicated by a blue border around the data entry field. Selecting a data item will mark the field with a blue border around the data entry field. In the right schematic representation of the form, one can select a task to perform by clicking in one of the columns: Queries, SDV, Coding, and Annotations. Note: depending on one s role more or less task (columns) can be available in this menu. The data items which have been marked for SDV during the SDV set-up are visible as icons in the column SDV: = required = optional. To perform SDV on a specific data item, select the cell representing the data item for which one wants to do Source Data Verification, and the column SDV. An SDV window is displayed below the schematic representation of the ecrf (Picture 6.7.). Page 34 of 49

35 Picture 6.7. The option SDV is selected for data item Visit Date. In the bottom right part of the screen one can add the queries and see all queries which have been added to the data item. Clicking the button Add SDV will bring up a pop-up window in which one can mark the selected data item as either: Disapproved, To-do, or Approved. Picture 6.8. below shows the available SDV-marking options and the related icons. Picture 6.8. SDV pop window with optiosn to mark data item as disapproved, to-do, or approved. Note: Negative SDV queries, are also displayed under the Queries menu (see section 5 and Picture 5.4 on page 25). The icons within the SDV column of the overview will be updated accordingly. Page 35 of 49

36 Picture 6.9. Approved SDV marking with at the bottom the account name performing the SDV, as well as date and time. The approved icon is also visible in the overview behind the data item in the SDV column. 7. Annotations Annotations are designed for temporarily attaching notes to ecrf s, similarly to what Post-its do for paper documents. It can serve as an (internal) message service by allowing other users to read the notes. Annotations can be attached to specific data items, as well as to entire forms or patient dossiers (see Picture 7.1). Picture 7.1. Annotations menu. Page 36 of 49

37 Clicking one of the icons (annotation on data item, annotation to form, and annotation to patient) brings up a window in which the message/note can be specified (see Picture 7.2). Picture 7.2. Annotations specification window. If the annotation is attached to a specific data item, the label of the data item is mentioned at the top (behind bind to) of the Annotations specification window. One can specify whether the annotation is visible for all users having access to the form, users with the same role only, or private. Once attached, the annotation is displayed as a yellow field. Depending on whether the annotation was created for a specific data item, form or patient, it can be found under the related menu tabs (Picture 7.3.) Picture 7.4. Example of an annotation, linked to a specific data item. Page 37 of 49

38 8. Activities The Activities overview provides a means to display Data Management activities by time and type of activity. As can be seen in Picture 8.1, time ranges can be specified and types of activities can be set by selecting one or more of the available settings to the left of the overview. Picture 8.1. Activities overview. The overview updates the displayed information instantly after changing a setting. As for all other overviews within the Data Management environment, the Activities overview can be arranged, filtered and sorted, as well as exported. If, for instance, reviewing only the activities of last week, a CRA or Monitor could verify these activities one-by-one and set each activity to verified by using the Set verified button at the top right of the overview (see Picture 7.2). Working in this way, one can easily see which data has been reviewed and which has not. Picture 8.2. Set and clear Reviewed buttons of the Activities overview. Page 38 of 49

39 The first column in the overview named R, allows selecting the reviewed activities. An activity can be set reviewed by selecting the Set Reviewed button in the top right part of the Activities overview (Picture 8.3). Picture 8.3. Activities can be set as reviewed and filtering can be performed on these as well. 9. Form locking, Set verified, and Sign off 9.1 Set form verified and/or form locking There are generally two ways in which CRA s, Monitors, Central Data Managers, or persons with similar roles can set one or more forms as verified or locked. 1. One option is through the SDV overview under the menu Tab. Accessing a form from within the SDV overview not only gives the opportunity to perform various tasks (e.g. SDV, Queries, Coding) but also allows to set a form as verified (or mark as Signed off or locked) depending on one s role. There is an option Set Status available above the schematic representation of the ecrf (see Picture ). Page 39 of 49

40 Picture Set form status options at SDV overview. The option Set Status is always performed on a form level. To perform this type of action for multiple forms, option 2 described below is available. Choosing the option of setting the form as verified, brings up a window in which one needs to specify a password to confirm the action (See Picture 9.1.2). The password is the same as the one used to access the Data Management environment. Page 40 of 49

41 Picture A password is required before setting the form status. Going back to the SDV overview, one can immediately notice the updated form status (Picture 9.1.3). Picture SDV overview also provides information about form status. Page 41 of 49

42 2. Set multiple forms verified (or perform other actions) at once Another means to set forms verified or locked is via the Patient dossier. Access a patient dossier through the Patient overview and click the button Form Options at the bottom of the navigation pane (Picture ). Picture Form options available per patient dossier. The next menu shows a representation of the navigation pane where all visits containing forms for which data has been entered are expanded (Picture ). Page 42 of 49

43 Picture 9.5. Form option menu allowing to quickly perform several action sto one or more forms. Each form can be selected by checking the box in front of it. Quick select options are available as well (e.g. select all Submitted or all locked forms). Set Verified can then be performed on the selected form by choosing this option under Actions. More actions can be available depending on one s role in the study. 9.2 Form locks and Sign off Form locks and Sign off can also be performed directly from within an open form. The Form locks and Sign off menu is another menu, available for each form. The Form locks and Sign off menu is indicated by the following icon:. The menu offers the two functions Lock form and Sign off (see Picture ). Picture The Form locks and Sign off menu Page 43 of 49

44 Locking a form changes the status of a form into read only, which means no data can be entered or changed. Form locking is performed by Central Data Management. If data needs to be altered after a form has been locked, a request can be made to the Central Data Management. Signing off a form is typically the task of Principal Investigators. Once a form status is changed into Signed off, this is indicated by a form name. -icon in front of the The Form locks and sign off menu has two tabs: Lock status, and a History. The History tab shows an overview of all Lock and Unlock actions, including date and time, as well as the name of the user performing these actions (see Picture ). Picture The History Tab of the Form locks and Sign off menu As explained in section 9.1. there it is also possible to perform Locking and Sign off actions on more than one form at the same time, via the Form Options under a Patient dossier. 10. Monitoring tab The Monitoring Tab provides overviews for 1. Present versus expected data, entered on the Data Management environment 2. Missing data, arranged by clinician, patient, Study Event (i.e. Visit), Visit sequence number, form, and finally data item. Page 44 of 49

45 Missing Data overviews are generated based on the missing data definition. By default, this missing data definition is created on the basis of the built in/pre-programmed edit checks indicating a data item is a required field. Picture Missing Data definition menu, which is available under the Monitor Tab. The default missing data definition can be copied to be altered for a more specific Missing Data report. Choose the - icon next to the view button of the Standard missing data values. A window will be displayed to specify which type of forms (e.g. saved, submitted, verified, etc.) will be taken into account. Picture New Missing Data definition. After a new Missing Data Definition is copied, it can be modified by clicking the Modify button. The left pane of the Missing Data Definition page, lists all visits and forms. Click on a form in the left pane to open a schematic representation of the data items on that form. Next, click on a Page 45 of 49

46 data item in the middle pane. The right pane will indicate whether the data item is currently set as mandatory ( ) or not ( ). One can then change this into (Non-) Mandatory. Picture Edit view of the Missing Data definition page. After changing a data item from mandatory into non-mandatory or vice versa, a pop up window is displayed. Here, one can indicate whether the changes should apply to the current form only, the current event (when it concerns a repeating form or repeating visit) or to all visits. Picture Indications for making the change apply to only the current form, the current event or all events. After finishing setting up the new Missing Data Definition, rebuild the overview (see Picture 10.5.). Page 46 of 49

47 Picture Missing data definitions. To generate the overview, always press the button rebuild overview to include the most recent data. Next, one can open the Missing Data overview (see Picture 10.6.). Picture Missing data overviews. To generate the overview, always press the button rebuild overview to include the most recent data. 11. User (profile) tab The User Tab contains several user specific options. The user profile menu offers information about ones accounts status, what role one has in the study, and the date and time of one s previous access to the Data management environment. There s also an option to change ones password (see Picture 11.1.).. Page 47 of 49

48 Picture The User Tab, containing user profile information. The user Tab also contains the personal drop-box in which files (e.g. ODM Exports) are placed for up- and/or download. Users with the right permissions (e.g. Privileged Users/Administrators), can queue an ODM data export (which is arranged from within the Options Tab), which will be placed in their personal Drop box. They can then upload the Data Export file locally and then upload the file to place it in the Drop Box of another user, or even copy the Data Export directly to the Drop Box of another user. Picture shows the available options. Picture Options and Download button for ODM data exports Page 48 of 49

49 1. Appendix A Field Choose box options Table 1. Field Available fields within the Field Chooser box to be inserted as columns in the Patients overview Description i #A Total number of data item annotations #A-F Total number of form level annotations #A-P Total number of patient level annotations #FQ-C Number of closed queries on Forms #FQ-O Number of open queries on Forms; Open initial, form level, queries #FQ-R Number of non-closed queries on Forms: Open form level queries with replies #L Total number of locked forms #PQ-C Number of closed queries on Patient #PQ-O Number of open queries on Patient #PQ-R Number of non-closed queries on Patient #S Number of submitted forms #Sa #Sd #Sm #TF #TQ-C #TQ-O #TQ-R Number of saved forms Number of submitted forms with discrepancies Number of submitted forms with missing values Total number of forms Combination of all closed patient- and form level queries Number of open queries on Patients and Forms; Combination of all open patient- and form level queries Number of non-closed queries on Patients and Forms; Combination of all non-closed patient- and form level queries Number of verified Forms Clinician and Institute code; Combination of institutes and all investigators per institute Study name: Could be useful when making an export of the patient overview. i All numbers are displayed per patient Page 49 of 49