CRA - Monitor OC RDC 4.5.3 HTML User Guide Page 1 of 46
TABLE OF CONTENTS Accessing OC RDC Steps for Access Logging On Change Password Computer and System Security Study and Site 3 4 5 5 6 Navigating OC RDC Selecting and Opening a Casebook Spreadsheet Icons for ecrfs Selecting and Opening an ecrf Navigation Tools Toolbar Components of the ecrf Right-click Functionality 8 10 10 11 12 12 Discrepancy Management System Generated Discrepancy Manual Discrepancy Discrepancy Colors CRF Navigator - Discrepancy Tab Routing Discrepancies Closing Discrepancies Viewing Discrepancy History 13 14 15 16 17 19 21 CRA Verification Process Verify an ecrf Un-Verify an ecrf Re-Verify an ecrf Group Verify ecrfs 22 23 24 26 OC RDC Features Viewing Investigator Comment in the CRF Navigator Audit History CRF Search Feature Site User Processes Marking an ecrf as Blank Unmarking an ecrf as Blank Inserting Additional Visits Patient Validation Principal Investigator Approval Process 28 29 30 33 34 35 37 38 Logging Out Of OC RDC 41 OC RDC Training Support 42 Page 2 of 46
ACCESSING OC RDC Steps for Access In order to gain access to Oracle Clinical Remote Data Capture 4.5.3 for this clinical trial, you must: 1. Complete SOP CDM-04 for Electronic Data Capture in LMS. 2. Add Oracle Clinical RDC 4.5.3 (CLN3-01964) to your LMS Learning Plan and complete the online training for your role via the link in LMS. 3. Complete the competency test in LMS and verify training completion. 4. Notify your PM/CTM so they can request an account and study access for you via efusion. You will receive your login information, via e-mail within 5 business days. If you do not receive your access information within 5 business days, please contact the EDC Support Center. For detailed instructions refer to the OC RDC 4.5.3 Online Training for Sites, Sponsors and External CRAs/Clinical Monitors document on the EDC Website in the User Reference Materials link. NOTE: PPD OC RDC 4.5.3 Training is only required to be performed once, regardless of the number of PPD OC RDC 4.5.3 studies you participate in. If you will be participating in User Acceptance Testing (UAT) for your study, you must complete training prior to test access being granted. Add your study URL to your Internet Explorer Favorites folder list for rapid access to your study website. A. When working in a PPD office, access your study database from the intranet using URL: http://intranet.ppdi.com/3/it1/3_it1_1_6_1_opa_scroll.htm Page 3 of 46
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ACCESSING OC RDC (cont.) B. Outside of a PPD office when you are not connected to the PPD VPN, access your study database via the external website for your study. Use of the external website will increase system performance because you will not be crossing firewalls multiple times to access your study. Click Login button to access the Logon window Logging On You will receive your user name and study URL, via email. Your password will be the one that you submitted in your Account Access Request Form. If you forget your password call the EDC Support Center. Navigate to the correct URL for your study. Click the Login button on the edc.ppdi.com/ website specific to your study (Server 1, Server 2 or Server 3) Enter the OC RDC Username and Password. o Text is not case sensitive. o Passwords will expire ever 90 days. o Passwords can not be reused. o The user is allowed three log on attempts after which the account will lock - call the EDC Support Center to unlock the account. o DO NOT share your login information with anyone. Click the Login button. Page 5 of 46
ACCESSING OC RDC (cont.) > Change Password Change Password There are instances in which users are required to change their password: Upon initial log in. Every 90 days. As needed a potential breach in security. To change your password: Click the Change Password link at the top any page. Enter your Old Password. Enter your New Password. Re-enter the New Password for confirmation. Click on the Apply button. Computer System and Security Security is an important issue when working with a remote data capture (RDC) system. To limit unauthorized access, security features have been incorporated in the OC RDC system. Users should log off of the OC RDC if they need to step away from the computer. If the computer is inactive (no keyboard or mouse activity) for a specified amount of time, the system automatically times out. Users will lose any unsaved work and they will need to log back into the system to continue working. The following message box displays: Page 6 of 46
The window will have to be closed to log in again. NAVIGATING OC RDC Study and Site The RDC Home tab displays after users have logged into OC RDC HTML, and will be the starting point for all activities. The RDC Home Tab is used to select the patient(s) and data that you wish to view on the RDC main spreadsheet. The Home tab can be accessed at any time during the OC RDC HTML session. The RDC Home Tab will display with a default Study and Site Patient Selection List. Other studies and/or sites can be accessed from the drop-down list(s). Summary information can be viewed by clicking on the Study and Site Summary link on the upper right-side of the Home Tab. Page 7 of 46
NAVIGATING OC RDC (cont.) > Study and Site Patient summary information can be viewed by clicking on any given patient icon. Also note that the icons have color coding, which indicate the presence or absence of discrepancies (data errors): Red indicates a discrepancy actionable to the person or user group logged into the system. Yellow indicates a discrepancy actionable to someone within a different user group (i.e. CRA, DM or PVG). White indicates there are no discrepancies on the patient data. A grey question mark indicates a patient number without data. Page 8 of 46
NAVIGATING OC RDC (cont.) > Casebook Spreadsheet Selecting and Opening a Casebook Spreadsheet Navigate to the Patient Search area. Use the + sign to expand the Patient Search section. Enter your assigned subject number in the first Range field, or use the Magnifying glass icon to select a patient number from the List of Values available. Click the Go button. Place a checkmark in the box to the left of the desired patient number. Click the Go button. Page 9 of 46
NAVIGATING OC RDC (cont.) > Casebook Spreadsheet NOTE: Patients can also be selected directly from the Patient list area for the study site, as illustrated bellow. Using the Next 50 drop-down list or hyperlink is another way to display a different set of patient numbers: Place a checkmark in the box to the left of the desired patient number. Click the Go button. The Casebook Spreadsheet for the selected patient will display, once the Go button is clicked. The Casebook Spreadsheet is the only page where you can initiate data entry for an electronic ecrf. The ecrf icons appear on the Casebook Spreadsheet. The ecrf is opened by clicking on its associated icon. Page 10 of 46
NAVIGATING OC RDC (cont.) > Casebook Spreadsheet Icons for ecrfs Description Icon The ecrf has been marked as blank. Blank CRF Other Discrepancy No data has been entered yet. Entry expected Entry complete Batch Loaded Active Discrepancy Verified Header information present but no response data has been entered. Created Description Icon All required CRF header and Section header information is complete and at least one question area response field is completed. The data has been entered electronically via batch data load into the database by data management. (i.e. Central Lab, ECG) In some instances, batch loaded data may not be visible. The ecrf has at least one open discrepancy that requires the current users attention. Requires Re-verification Approved Requires Re-Approval Locked The ecrf has at least one open discrepancy that requires another users attention. The ecrf has been source verified by the CRA. The data on the page has been changed since CRA verification. The ecrf has been approved by the Investigator. Data on the page has been changed since Investigator approval. All ecrf data has been collected and verified. A locked ecrf may be viewed in a read-only mode and its data cannot be updated. The locking task is typically performed by a data manager. Selecting and Opening an ecrf Click the Visit drop-down list. Select the desired visit from the list. Page 11 of 46
NAVIGATING OC RDC (cont.) > ecrf Click on the desired ecrf icon to open the page. Maximize the ecrf window. OC RDC Tools Once the ecrf window is open a number of icons, links, and navigation buttons are available. Navigation Tools: To navigate through an ecrf that contains multiple pages, Navigation tools appear at the top of the ecrf. The navigation tool that appears at the top right corner of the ecrf window is a toggle button for moving to the Previous CRF or the Next CRF. The TAB key moves the cursor from field to field on the ecrf page. Clicking in a data field using the mouse moves the cursor to the selected data field. Use the scroll bars to navigate through and view the ecrf fields. Page 12 of 46
NAVIGATING OC RDC (cont.) > ecrf Toolbar Icons: Toolbar icons are used as described bellow: Toolbar Icons Name Add Discrepancy Investigator Comment Delete Row Description Allows users to create new discrepancies or edit existing ones. Allows site users to add comments to data fields. Allows site users to delete rows of data. Blank Flag Tool Allows site users to mark the entire ecrf or one or more individual sections blank. Verification (History) Allows CRAs to mark a ecrfs as verified and users to view verification history. Approval (History) Allows investigators or designee to electronically approve ecrfs and users to view approval history. Delete CRF Allows site users to delete ecrfs. Print Allows users to print ecrf. Save (Alt+S) Allows users to save their work. Right-click Functionality Page 13 of 46
Right-click functionality is available when working in an ecrf. The popup menu that displays provides some of the same options as the Toolbar icons. On an open ecrf: Right-click on a data field to display the list. Select the desired option from the list and proceed with the action selected. DISCREPANCY MANAGEMENT A discrepancy within OC RDC is defined as Data that falls outside of an expected range of values or is otherwise 'flagged' during the edit check process. OC RDC automatically raises a discrepancy to alert users to a possible problem with a response value, or a group of response values. Edit checks are built into the study database that are executed at various points in the data entry process. A discrepancy can be created automatically by the system or manually by a user with appropriate privileges. Also, discrepancies may be created on a single data field or on a section within an ecrf. System Generated Discrepancy A system generated discrepancy alerts the user that there may be a problem with data that has been captured or is missing from a data field. OC RDC executes some edit checks upon data entry for site users to address immediately or route to thecra. These are known as univariate or simple discrepancies. Other edit checks are executed when a ecrf is saved or after validation of the data occurs. These are know as multivariate or complex discrepancies. Examples why system generated discrepancies may appear: If data captured in a data field is not in the correct format or is not part of the acceptable list of values (LOV) for that data field. Examples include incorrect date format, missing data, lab values out of range, etc. These discrepancies will appear as soon as the user tabs off of the field containing incorrect data Where data comparisons are made against multiple data fields, such as selecting Other, but not providing a Specify. Discrepancies will appear as soon as the page has been saved. If there is inconsistent or inaccurate data across multiple data pages, such as cross checking information on the adverse event page against the medication page. Discrepancies will not appear until after a validation process is run either during the nightly automatic validation or by a manual validation by the user. Page 14 of 46
DISCREPANCY MANAGEMENT (cont.) > Manual Discrepancy Manual Discrepancy A manual discrepancy is created by someone who has the appropriate privilege to do so. Typically, monitors (CRAs), Data Managers, and PVG raise manual discrepancies (or queries) and route them to site users, to respond, based Source Document Verification (SDV) or remote review of the data. Discrepancies can be created on a single data field or on an entire section within the ecrf. CRAs, Data Management and PVG are also able to close manual discrepancies in the system after the site has appropriately addressed the discrepancy. Page 15 of 46
Depending on access privileges, you initiate section discrepancies in association with CRF sections. You can use a section discrepancy to communicate CRF section related issues among site personnel, data managers and monitors. Unlike a field discrepancy, you can associate multiple section discrepancies with a CRF section. DISCREPANCY MANAGEMENT (cont.) > Colors Discrepancy Colors There is a color scheme associated with the ecrf icons on the OC RDC Casebook Spreadsheet and with the data fields on an open ecrf when a discrepancy is present. The color scheme indicates the status of the discrepancy and who the discrepancy is actionable to. If a discrepancy has been created on a section within an ecrf, the discrepancy color displays as a colored bar to the left of the data fields associated with the discrepancy. A red icon on the OC RDC Casebook Spreadsheet and a red field or bar on the ecrf indicates the discrepancy requires action by the person logged in or someone else who shares the same role. A yellow icon on the OC RDC Casebook Spreadsheet and a yellow ecrf field or bar indicates that the discrepancy is actionable to someone outside of your role. A white icon on the OC RDC Casebook Spreadsheet and green field or bar indicates the discrepancy is closed. Page 16 of 46
Closed discrepancy Actionable discrepancy Section discrepancy routed to CRA DISCREPANCY MANAGEMENT (cont.) > CRF Navigator CRF Navigator - Discrepancy Tab The CRF Navigator is a window pane on the right side of an ecrf that contains two tabs, one of which is the Discrepancy Tab. The discrepancy tab lists any discrepancies on the open page allowing the site user the option of resolving/closing or routing the discrepancy. Page 17 of 46
DISCREPANCY MANAGEMENT (cont.) > Routing Routing Discrepancies When managing discrepancies, the discrepancy may need to be routed to the Investigator for verification and/or clarification. From the OC RDC Casebook Spreadsheet, click the ecrf cell containing a red icon Page 18 of 46
From the OC RDC Casebook Spreadsheet, click a red ecrf icon. The ecrf displays. Click the Open CRF Navigator button to the right of the ecrf to open the CRF Navigator Pane. CLICK on the desired Discrepancy in the List to display the Details below. Select Send to Investigator from the Action drop down list. Click the Go button. The Discrepancy Action Send to Investigator dialog window displays. Enter a Comment explaining why the discrepancy is being routed. Click the OK button. (Field(s) will highlight in Yellow) DISCREPANCY MANAGEMENT (cont.) > Routing Page 19 of 46
Click the Save icon. Click the OK button. Click the red X to close the window or navigate to the Previous CRF or Next CRF in this visit using the buttons in the upper right of the window. Click the Refresh button, to update the Casebook Spreadsheet. Page 20 of 46
DISCREPANCY MANAGEMENT (cont.) > Closing Closing Discrepancies It is appropriate to close discrepancies that have been manually created and resolved by the site user(s). From the OC RDC Casebook Spreadsheet, click a red ecrf icon. The ecrf displays. From the OC RDC Casebook Spreadsheet, click the ecrf cell containing a red icon From the OC RDC Casebook Spreadsheet, click a red ecrf icon. The ecrf displays. Click the Open CRF Navigator button to the right of the ecrf to open the CRF Navigator Pane. CLICK on the desired Discrepancy in the List to display the Details below. Select Close-resolved from the Action drop down list. Click the Go button. The Discrepancy Action Close-resolved dialog window displays. Page 21 of 46
DISCREPANCY MANAGEMENT (cont.) > Closing Enter a Comment if needed Select an appropriate resolution reason. Click the OK button. (Field(s) will highlight in Green) Click the Save icon. Click the OK button. Click the red X to close the window or navigate to the Previous CRF or Next CRF in this visit using the buttons in the upper right of the window. Click the Refresh button, to update the Casebook Spreadsheet. Page 22 of 46
DISCREPANCY MANAGEMENT (cont.) > History Viewing Discrepancy History Once a discrepancy is saved to an ecrf, users are able to view the history of the discrepancy in the CRF Navigator. To view the discrepancy history: From the OC RDC Casebook Spreadsheet, click the ecrf icon containing a discrepancy of any status. The ecrf displays. Click the CRF Navigator button to the right of the ecrf to expand the CRF Navigator Pane. CLICK on the desired Discrepancy in the List, to display the details below. Click the History button to display the Discrepancy History window. When finished viewing the history, click the Close button. Page 23 of 46
CRA Verification Process Once the site has finished data capture, saved the ecrfs, and resolved any system generated discrepancies, the ecrfs can be reviewed and source document verified according to the monitoring plan. Verify an ecrf From the OC RDC Casebook Spreadsheet, click the ecrf icon ready for and needing CRA verification. The ecrf displays. Verify the responses entered in each data field; be sure to review all fields. Click the Verify button. Enter a Verification Comment if needed; e.g., SDV to indicate the ecrf has been source verified. If desired, place a checkmark in the Remember comment for subsequent CRF Verification operations. Checking this box will allow the verification comment to be included with all other ecrfs verified during the current session if a checkmark is placed in the box, the comment will be attached to any ecrfs that have been verified. Click the Verify button. Click the red X to close the window or navigate to the Previous CRF or Next CRF in this visit using the buttons in the upper right of the window. The Verify CRF dialogue window displays. Page 24 of 46
Click the Refresh button, to update the Casebook Spreadsheet and display the Verified ecrf icon. CRA Verification Process (cont.) > Un-Verifying Un-Verify an ecrf If an ecrf was verified in error, CRAs have the ability to un-verify an ecrf: From the OC RDC Casebook Spreadsheet, click the ecrf icon requiring un-verification. The ecrf displays. Click the Verify button. Enter a Verification Comment if needed. If desired, place a checkmark in the Remember comment for subsequent CRF Verification operations. Checking this box will allow the verification comment to be included with all other ecrfs un-verified during the current session if a checkmark is placed in the box, the comment will be attached to any ecrfs that have been un-verified. Click the Undo Verification button. Click the red X to close the window or navigate to the Previous CRF or Next CRF in this visit using the buttons in the upper right of the window. Click the Refresh button, to update the Casebook Spreadsheet, to display in unverified The Verify CRF dialogue window displays. Page 25 of 46
ecrf icon. Page 26 of 46
CRA Verification Process (cont.) > Re-Verifying Re-Verify an ecrf If there is a change on an ecrf due to investigator comments or discrepancies being added/modified (changed, added, deleted), or due to a database modification; after an ecrf has been verified, then a re-verification icon displays on the Casebook Spreadsheet, and the ecrf will need to be re-verifed. From the OC RDC Casebook Spreadsheet, click the ecrf icon requiring un-verification. The ecrf displays. Select the Changed since last verified Highlight, from the Highlight drop-down list. Fields that have been modified will be highlighted in blue. Click the Verify button. The Verify CRF dialogue window displays. Page 27 of 46
CRA Verification Process (cont.) > Re-Verifying Enter a Verification Comment if needed. If desired, place a checkmark in the Remember comment for subsequent CRF Verification operations. Checking this box will allow the verification comment to be included with all other ecrfs verified during the current session if a checkmark is placed in the box, the comment will be attached to any ecrfs that have been verified. Click the Undo Verification button. Click the red X to close the window or navigate to the Previous CRF or Next CRF in this visit using the buttons in the upper right of the window. Click the Refresh button, to update the Casebook Spreadsheet, to display in unverified ecrf icon. NOTE: Users can select the Audit History Highlight to view the history of a data field that was modified. Changes to investigator comments or discrepancies without data changes will not display in the Audit History tool. To view the history of changes to investigator comments or discrepancies, utilize the CRF Navigator in the right window pane. Reference the OC RDC Features section for details regarding Audit History (page 29). Page 28 of 46
CRA Verification Process (cont.) > Group Verifying Group Verify ecrfs Since the monitoring plan specifies which data needs to be source document verified, it is useful to have a verified status which represents the amount of patient information that was processed or group verified at a particular monitoring visit, rather than represent only the individual ecrfs that were verified against the source. Group verifying ecrfs per monitoring visit allows CRAs to track the work that they did at a particular site visit. In order to group verify, use the Search window to filter the data that displays on the OC RDC Casebook Spreadsheet. Place a check mark in the box to the left of the desired patient icon in the Casebook Spreadsheet. Select Verify from the Select Patients and drop-down list, and click the Go button. Page 29 of 46
CRA Verification Process (cont.) > Group Verifying Enter a Comment if needed, and keep the default check mark for Skip CRFs with discrepancies. Click the Continue button. Click the Yes button in the Verify CRFs Warning window. Click the Close button in the Verify CRFs Confirmation window The Casebook Spreadsheet displays with the appropriate ecrf Verified icons. Page 30 of 46
OC RDC FEATURES Viewing Investigator Comment in the CRF Navigator When the CRF Navigator - Investigator Comment tab is selected, all data fields which contain an Investigator comment are listed. To view a comment: On an open ecrf, select the Investigator Comment Highlight, from the drop-down list in the top left corner of the ecrf. Any field containing a comment appears in magenta (purple-pink). Select the investigator comment item from the List or the ecrf. Details of the Investigator comment will display in the CRF Navigator pane. Additional information can be reviewed by clicking the History button. Page 31 of 46
OC RDC FEATURES (cont.) > Audit History Audit History OC RDC automatically keeps a history of any data changes that have occurred for each field after the ecrf has been saved the first time. The system prompts users to supply a change reason when data is modified on an ecrf that has been saved. The history contains information on who changed the data, the previous value, the date and time the modification occurred and a reason for the change. Any field that has an audit history displays in blue when the Audit History highlight is selected. To view the history of a data field On an open ecrf, select the Audit History Highlight, from the drop-down list in the top left corner of the ecrf. Any field containing a history displays in blue. Click the Audit History button at the bottom of the ecrf to expand the Audit History pane. In the Audit History pane, information regarding fields with audit history will display. Page 32 of 46
OC RDC FEATURES (cont.) > Audit History A separate Audit History Details window can be viewed, by clicking on the Details button. CRF Search Criteria Once data capture has begun for the study, users are able to use search criteria to sub-set or filter data for display. The Search feature in helps you locate specific information from different ecrf pages. On the Casebook and Review tabs, CRF search criteria fall into two sub-categories: 1. CRF Status Criteria Under this category, you select search parameters based on the status of the CRF. The various CRF status parameters are: Entry: Select the entry status of the CRF to locate. Your options are- All, Blank, Entry Complete, and Batch Loaded. Discrepancy: Select the discrepancy status of the CRF to locate. Your options are - All, Active, Other, Open (Active & Other), Clean (None or Closed). The Clean option is replaced by Closed on the Review tab. Approval: Select the approval status of the CRF to locate. Your options are- All, Not Approved, Approved, Awaiting re-approval, and Approval Undone. Verification: Select the verification status of the CRF to locate. Your options are- All, Not Verified, Verified, Awaiting re-verification, and Verification Undone. Page 33 of 46
OC RDC FEATURES (cont.) > Search Criteria 2. CRF Source Criteria You can select search parameters based on the source of the CRF. There are three sources from which to locate a CRF. Casebook: Select the casebook used at the time of initial data entry into the CRF. Your options are All or individual casebooks in the study, sorted alphabetically in the dropdown selection list. This parameter is useful if patients, whose data was entered using an earlier version of the casebook, are reassigned to a new version of the casebook. Visit: Select the number of the visit during which the CRF data was collected. If a casebook is specified, OC RDC displays only the visits defined for the selected casebook in the drop-down selection list. If the casebook selection is All, OC RDC displays all visits defined for the study. CRF Name: Select the name of the CRF to review from the drop-down list. This parameter is useful in reviewing all CRFs of a certain type, for example, all Adverse Events forms, or all Concomitant Medications forms. The Search features allow users to specify the data display in greater detail. This is a useful tool which has the potential of assisting users with their work flow for data capture and discrepancy management. Page 34 of 46
Click the Go button to perform the search and retrieve the desired patient data. OC RDC FEATURES (cont.) > Search Criteria The Casebook or Review tab will update with the desired CRF Search Criteria. Page 35 of 46
SITE USER PROCESSES Marking an ecrf as Blank If an entire ecrf or section within the ecrf will not be completed for a particular patient, or if a patient misses a protocol defined visit, the ecrf or section should be marked as blank. Marking an ecrf as blank alerts the study team that the ecrf (or section) has been left blank intentionally. If an entire ecrf or section is marked as blank, users are not able to Tab to or use the mouse cursor to click in any data entry fields, as they will be grayed out. Refer to the Study Specific ecrf Completion Guidelines for instructions on when it may be appropriate to mark an entire ecrf or section as blank. Users are also able to mark an ecrf that contains data as blank. All previously entered data on that ecrf page will be deleted. Open the ecrf which will be marked as blank; the ecrf displays. Click the Blank Flag Processing tool displays. Click the applicable check boxes to Mark an entire ecrf or Mark an ecrf section as blank. Click the OK button - the Reason for Change window displays if an ecrf that had been saved as Complete is being marked as blank. If applicable, click the drop down arrow and select a Reason for Change. If applicable, click the OK button to close the Reason for Change Window. Click the Save icon. Click the OK button.. The CRF Blank Section(s) Processing Window Page 36 of 46
Click the red X to close the window or navigate to the Previous CRF or Next CRF in this visit using the buttons in the upper right of the window. Click the Refresh button, to update the Casebook Spreadsheet. NOTE: The OC RDC system will automatically mark any section as blank, for entire sections that are saved without data, within an ecrf. An entire page can also be saved as blank by using the Check if Entire Page Blank box, on the ecrf page itself. SITE USER PROCESSES (cont.) > Blank ecrf Unmarking an ecrf as Blank The ecrf or sections marked as blank can be unmarked as blank to allow data to be entered on the ecrf. This is helpful if an ecrf or an ecrf section was marked blank in error, or if a patient did show up for the scheduled visit. To unmark an ecrf as blank Open the ecrf that has been marked as blank. Click the Blank Flag Processing icon displays. Un-check the boxes to Mark an entire ecrf or Mark an ecrf section as blank. Click the OK button - the Reason for Change window displays. Click the drop down arrow and select a Reason for Change. Click the OK button to close the Reason for Change Window. Click the Save icon. Click the OK button. Click the red X to close the window or navigate to the Previous CRF or Next CRF in this visit using the buttons in the upper right of the window. Click the Refresh button, to update the Casebook Spreadsheet.. The CRF Blank Section(s) Processing Window Page 37 of 46
SITE USER PROCESSES (cont.) > Additional Visits Inserting Additional Visits Site users may need to manually add a visit page if they have completed data entry on an ecrf page, but still have more data to enter (i.e. Adverse Events, Medical History, ConMeds, etc.). The Study Team should advise when to insert additional visit pages based on the study protocol. You can add a new visit page to a visit from the Casebook Spreadsheet using the Add Visit Page button. Ensure that the new visit page is being added to the correct visit. Not all pages will be available for adding to the visit. Contact your study team regarding visits that are available for adding a visit page. To add a visit page: Select a visit from the Visit dropdown list. Place a check mark in the box to the left of the desired patient icon in the Casebook Spreadsheet. Click the Add Visit Page button. The Add Visit Page dialog box opens, listing all the available CRFs for the current visit Select the appropriate ecrf by clicking on the radio button. Page 38 of 46
SITE USER PROCESSES (cont.) > Additional Visits Click Continue to proceed to the next dialog. Leave the default sub-visit number. Click Apply to add the new page to the current visit. The Casebook Spreadsheet will display an empty CRF icon in the designated patient row and CRF column. Notice that a new CRF column may have been inserted labeled with both the CRF name and the sub-visit number. Click the new CRF icon to open the ecrf, for data entry. Page 39 of 46
SITE USER PROCESSES (cont.) > Validation Patient Validation Each database has an automatic validation process to run edit checks on a nightly basis. These edit checks are part of the protocol specific database design and ensure that fields within an ecrf and across multiple ecrfs contain data that corresponds appropriately. If data fields contain data outside of the edit check parameters, a discrepancy will be generated by the system. While these nightly edit checks are helpful, there may be instances when a site user would like to confirm that all data fields are correct as entered without waiting for the nightly validation. The site user is capable of running a manual patient validation. Patient Validation is a validation on all saved ecrfs in a site. This may include ecrfs that are not part of the current workset. Validating a site allows you to view and manage your discrepancies in real time. If a discrepancy was created by a validation procedure, you must revalidate the data to close/clear the discrepancy. To validate the ecrfs associated with a site In the Casebook tab, click the check box next to the appropriate patient icon. Select Validate from the Select Patients and drop down list. Click the Go button. Click Continue when the Validate Patients window appears. Read the Confirmation dialog window to confirm successful validation. Click the Close button. Page 40 of 46
SITE USER PROCESSES > Approval Investigator Approval After all discrepancies have been closed, and all ecrfs have been verified by the CRA, the investigator approval process can proceed. The study team will determine when a casebook is complete and ready for approval. The Principle Investigator and/or their designee are the only site staff who will have this access. The following steps outline the process for approving ecrfs. Click the check box next to the patient icon on the Home tab. Leave the default selection of Open Patient Casebooks in the Select Patients and drop down list and Click the Go button. Click the check box next to the patient icon on the Casebooks tab. Select Approve from the Select Patients and drop down list. Click the Go button. The Approve CRFs dialog window displays, where you are required to ENTER your username and password and a comment if applicable. LEAVE default check marks selected. (in most instances) Page 41 of 46
CLICK the Continue button. SITE USER PROCESSES > Approval Click Yes when the Approve CRFs warning dialog window appears. Click the Close button on the Confirmation window. Approved CRFs will display on the Casebook Spreadsheet with the Approved CRF icon. Re-Approve or Undo Approval at the ecrf Page Level If a data change occurs on a page due to data being added/modified, or a database modification, after Investigator Approval, the re-approval icon re-approved. will appear, and the ecrf will need to be If an ecrf was approved in error, the Principal Investigator is able to un-approve the ecrf. The Investigator would conduct the following steps re-approve or undo approval of a single ecrf. Open the ecrf in need of re-approval or un-approval. Click the Approve icon. Page 42 of 46
SITE USER PROCESSES > Approval CLICK the Re-Approve or Undo Approval button in the Approve CRF window, add a comment if needed. Enter username and password in the CRF Approval Signoff dialog window. Click the OK button. Click the Close button when the CRF Approval Signoff window appears. Page 43 of 46
LOGGING OUT OF OC RDC It is important that any work in an ecrf is saved before attempting to log out. Failure to save work results in the data or changes being lost. Properly logging out ensures that your account session is completely terminated. To Log out: Click the Logout link at the top of the screen. Close all open windows. Page 44 of 46
OC RDC TRAINING SUPPORT Training Options & Access Requests OC RDC application training is available for all OC RDC users. Application training covers functionality of OC RDC. OC RDC is an ecrf and not a direct data entry system; source documentation is required. All equipment provided to the site should ONLY be used for OC RDC or other PPD approved applications. The PPD EDC Support Center is available 24 hours a day, 5 days a week, with weekend and holiday pager support. Multilingual translators are available. The PPD EDC Support Center is for technical questions only. Please contact the CRA for study protocol or ecrf related questions. At the end of the study, a CD of all subject data will be provided to the sites - Investigator confirmation and sign-off is required after receipt of the entire site s study data on the CD. Until the CD is received, sites must continue to have access to PPD and their OC RDC data. All training sessions must be documented before access to a study protocol in the OC RDC application is granted. Training Materials The following OC RDC training materials are available for all site users: On-line training Quick Reference Guide Investigator Site User Guide Page 45 of 46
Need Technical Help? CALL THE PPD EDC SUPPORT CENTER EDC Support Center Phone Numbers Global + 44 (0) 1223 374580 North America + 866-765-0279 World Phone toll free numbers outside the US and Canada can be found at http://edc.ppdi.com/html Page 46 of 46