Clinical Trials Reporting Program

CTRP Release 3.9

Registration & AccrualsApplication

Enhancements

April 3, 2013

Registration ApplicationEnhancements

2

Key Registration Application Enhancements

• Registration of Non-interventional via the CTRP Registration application user interface

• Site-level Accrual Access ManagementRegistered users can now be granted accrual access to ALL trials belonging to their affiliated organization by the Site Admins

• Org Family-level Accrual Access ManagementA 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 ApplicationEnhancements

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