Clinical Trials Reporting Program CTRP Release 3.9 Registration & Accruals Application Enhancements April 3, 2013

Registration Application Enhancements 2

Key Registration Application Enhancements Registration of Non-interventional via the CTRP Registration application user interface Site-level Accrual Access Management Registered users can now be granted accrual access to ALL trials belonging to their affiliated organization by the Site Admins Org Family-level Accrual Access Management A Site Admin can now grant accrual access to ALL trials belonging to all organizations within a family to a registered CTRP user from any of the family member organizations Ability to turn off CTRP system notifications A new (optional) data field added to capture Secondary Purpose for Interventional Trials 3

Key Registration Application Enhancements Improvements to the User Interface -Character counters in text fields keep track of character limits as the users enter text. -Participating Sites are now listed alphabetically by default when viewed from the search results page in Registration. -A cancellation confirmation window pops up now if you cancel a trial registration. A number of improvements to XML & TSR content and formatting -The XML file now includes in the secondary ID section any identifiers that are captured in the Other Trial Identifiers field in CTRP. -Keywords are now formatted in the XML file to be fully consistent with the ClinicalTrials.gov formatting requirements. -Biomarkers are now listed alphabetically in the TSR. 4

Non-interventional Trial Registration 5

List of Valid Values Study Model code –Cohort –Case-control –Case-only –Case-crossover –Ecologic or community studies –Family-based –Other (Free test up to 200 chars) Time Perspective Code –Prospective –Retrospective –Cross-sectional –Other (Free text up to 200 chars) Non-Interventional Trial Type –Observational –Ancillary-Correlative Non-interventional Trial Registration 6

Site-level Accrual Access Management 7

Ability to Turn-off System Notifications 8

Ability to Capture Secondary Purpose (Optional) 9

Registry Search Results – Participating Sites Displayed Alphabetically 10

Trial Registration Cancellation Confirmation 11

3.9 Known Issues for Registry Application Non-interventional Trials -Registration only via the graphical user interface -Support for registration via batch upload or registration service is under consideration for a future release. -The submission of accrual data is not required for non- interventional trials at current time. Secondary Purpose Field -Currently only available only in the Registration User Interface, not via batch upload or the registration Service. -Stored in the database, but will not appear on the TSR or in the ct.gov XML file. Search Results Table and Other User Interface Improvements -The Search My Trials results table in Registry extends beyond the frame, requiring use of the horizontal scroll bar. This display issue will be corrected in a future release when the user interface is updated. 12

Amendment Processing Comments Amendments cannot be submitted for a trial in the CTRP if the Clinical Trials Reporting Office (CTRO) is processing a prior amendment. An enhancement request is under consideration for inclusion in a future CTRP release. 13

Accrual Application Enhancements

Key Accrual Application Enhancements Additional Ways to Manage Accrual Access -Site Administrators can now use the CTRP Registration application to authorize users to submit subject accrual data for trials associated with their affiliated organization or for any organization family members (covered under Registry enhancements in previous slides). Exporting Data -Details from the Prior Submissions page and the Accrual Counts page can now be exported to CSV or Excel files. Changes to Disease Coding -The system now verifies that all patients being accrued to a trial are coded using the same disease terminology. -Search can now be conducted for diseases in the application directly from the main menu. -Initiate a search upon pressing the ENTER key 15

Ability to Export Data for ‘Prior Submissions’ 16

Ability to Export Data for ‘Accrual Counts’ 17

Search Diseases From the Main Menu – No Need to Drill Down to a Study Subject Any Longer 18

Thank You 19