1. CTRP User Call November 13, 2013 Gene Kraus CTRP Program Director

2. Agenda Welcome Updates from CTRO Review of ClinicalTrials.gov Upload from NCI CTRP Brief comments on Results Reporting

3. Updates From CTRO

4. Turn Around Time The 10-day abstraction is from the date of a Externally Peer Reviewed / Institutional submission? For example: -Submission date: November 11, 2013 -On hold notice received November 12, 2013 for missing IRB -IRB received at CTRO on November 18, 2013 – the 10 days starts then.

5. Review of ClinicalTrials.gov Upload from NCI CTRP

6. First…A little background

7. NCI Related CTRP Trial Categories NCI-Supported -All trials sponsored or otherwise financially supported by NCI, including Cancer-Center sponsored trials NCI-Sponsored -NCI holds the IND and/or N01/N02 funded NCI-Managed -Trials that are reviewed and monitored by NCI. This includes all CTEP/DCP PIO trials submitted via the Clinical Data Update System (CDUS), all Cooperative Group trials, and all early phase trials submitted to the Clinical Trials Monitoring Service (CTMS) operated by Theradex.

8. NCI Trial Management All CTEP and DCP PIO trials are registered in CTRP -PDQ no longer registers or updates trials in the NCI ClinicalTrials.gov account. Note - PDQ/Cancer.gov will remain the public repository of cancer clinical trial information. -Trial sponsors are able to use CTRP information to register and update a trial in ClinicalTrials.gov The NCI ClinicalTrials.gov account contains only trials sponsored by the NCI -NCI is the Sponsor and Responsible Party per FDAAA -Non-sponsored trials have been transferred to the Sponsor -Applicable Clinical Trials are identified (Section 801) -Results reporting is performed by site designees

9. Roles and Responsibilities NCI CTRO/ClinicalTrials.gov Administrator -Register and maintain NCI Sponsored records in CTRP and ClinicalTrials.gov throughout the life of the study -Register and maintain NCI Managed records in CTRP assigns ownership to trial Sponsor in CTRP to facilitate ClinicalTrials.gov reporting with CTRP data -Monitor Primary Completion Date for all NCI Supported studies -Inform Results Reporting Designee of responsibility and grant access to NCI Sponsored trial record in NCI’s ClinicalTrials.gov account -Facilitate review of results, releases record once approval provided by CTEP/DCP

10. Roles and Responsibilities NCI CTEP/DCP PIO -Capture FDAAA information and provide this to NCI CTRO, for existing and new trials -Provide contact for CTRP Trial Owner for NCI-managed trials to receive TSR/XML -Work with NCI ClinicalTrials.gov Administrator to monitor Primary Completion Date (PCD) for Applicable Clinical Trials (ACTs) -Identify results reporting designee by the Primary Completion Date for NCI Sponsored ACTs -Review and approve results on NCI Sponsored ACTs prior to release in ClinicalTrials.gov

11. Roles and Responsibilities Cancer Centers & Groups -Report to NCI CTEP/DCP on applicable trials as established -Cancer Centers register and maintain Institutional trials in CTRP -Register and maintain Center/Group-sponsored trials (including NCI managed trials) * in ClinicalTrials.gov * (noted red for importance) CTRP data may be used if desired NCI requests the site report the NCT ID back to NCI CTRO -Report results on applicable trials NCI will delegate results reporting on NCI-sponsored trials to the site, results will be entered by the designee in the NCI ClinicalTrials.gov account

12. Using CTRP Data in ClinicalTrials.gov Manual XML upload or…. Upload Directly from NCI CTRP -Users can begin using this feature as soon as they receive the TSR from CTRP

13. Benefits of Using the CTRP Upload Feature Makes registering, updating, and amending trials quick and easy No need to review XML No need to log into system at both ends, handle XML file, etc. -- just log into PRS and enter a few fields More secure than manual upload method and is preferred by NLM -Additional data validation checks are included with this upload method Consistency checking of identifiers: NCI ID, Unique Protocol ID (Lead Organization ID), which helps prevent duplicate registration e.g. from a prior individual within the org

14. Benefits of Using the CTRP Upload Feature (Con’t) Handling of XML file increases chances of file version confusion/mistakes. Using direct transfer eliminates this risk Automatic PRS Record Log entry records transfer of information from CTRP Option to update location (site) data only from CTRP. Detailed help page

15. Make sure you are the “Trial Owner” for the trial you are uploading Be sure to include the PRS Organization Name (the one you use for ClinicalTrials.gov) CTRP Registration Account Requirements

16. ClinicalTrials.gov Protocol Registration System (PRS) https://register.clinicaltrials.gov/

17. PRS Main Menu

18. PRS Upload Information From CTRP Screen NCI Record ID: Enter the NCI assigned identifier for the trial, in the form NCI-yyyy-nnnnn, where yyyy is the year and nnnnn is a 5-digit number. Unique Protocol ID: This ID must match the "Lead Organization Trial Identifier" specified in CTRP. When creating a new PRS record, the ID must not match the Unique Protocol ID of any existing PRS records. When overwriting protocol or location information, the ID must match the Unique Protocol ID of the PRS record to be updated. * For trials previously owned by PDQ, you will need to modify the PRS record before upload* Upload Option: Select the upload option to: create a new PRS record, completely replace the protocol information in an existing PRS record or completely replace the location information in an existing PRS record. CTRP Username/Password: Enter the same username and password that you use to log into the CTRP system, to access the record to be uploaded. This username/password must be from NCI/CTRP -- not from PRS.

19. CT.gov Upload Information from CTRP – CTRP Upload Analysis Page

20. PRS Common Alerts for Upload The common errors/warnings/alerts: Anticipated primary completion date in the past. Sometimes the MANUAL upload automatically puts the IND/INDE Protocol indicator to “No.” This creates an Oversight Authority Alert indicating the authority should include the US Federal Government. To fix that, you would put the indicator to “ Yes ” and enter in the IND/IDE information in another box that appears when you check yes.

21. Upload Summary CTRP Upload feature is more secure, reduces errors and duplicate registrations, and is more time efficient. Be sure to include your PRS Organization Name in your account on the NCI CTRP Registration Site to ensure successful upload in ClinicalTrials.gov. When using the ClinicalTrials.gov Protocol Registration System (PRS) -Review trial IDs -Enter user name and password -Review and Release

22. Brief Comments on Results Reporting

23. ClinicalTrials.gov Results Entry Make sure to review the “Results Review Criteria”, available in the PRS Interface Proactively addressing the review criteria may expedite review and limit revisions

24. CTRP Top Ten List Top 10 Considerations When Entering Results

25. Top 10 Considerations When Entering Results 1.The Enrollment number in the protocol section conflicts with the number of participants Started in the Participant Flow module 2.The Arm/Group Description be used to provide additional details about the interventions administered (e.g., dosage, dosage form, frequency of administration) or groups evaluated. 3.Expand all acronyms and abbreviations (and include acronym in parentheses) 4.Provide a brief but explicit summary of the criteria used for Outcome Measure/assessment of progression/progressive disease 5.Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow Module. 6.The Outcome Measure should be specific and measurable by the Units of Measure provided. 7.Measure Title/Description (Number of Adverse Events) and Unit of Measure (# of Participants with adverse events) are inconsistent. 8.The Time Frame provided is not specific. The Time Frame should specify the specific time point(s) at which the outcome measure was assessed and for which data are presented. 9.Previous comments, have not been addressed. The record cannot be posted on ClinicalTrials.gov until the noted issues have been sufficiently addressed. 10.Provide brief, but informative Arm/Group Titles.

26. Send questions / topics for future calls

27. Thank You