1. NCI Clinical Trials Reporting Program CTRP User Meeting November 2, 2011 Gene Kraus CTRP Program Director

2. Status update -CTRO Metrics -October Review NLM Presentation “ClinicalTrials.gov – Overview and Implications of Recent PRS Updates” Summary - Amendment call from 10/12/2011 CTRP Account Migration Update Reminders Informed Consent Documents Templates Agenda

3. CTRO Metrics Metrics for period October, 2011 -Original submissions215 -Amendments34 Metrics January 2009 to date -Original Submissions5435 -Accepted4595 -Abstracted3917 -QC2887 -Trial Summary Report Sent2518 Abstraction Verified637 -Submitted amendments559

4. October Review User call – October 5 th Minutes: https://wiki.nci.nih.gov/display/CTRP/10- 05-2011+CTRP+Meeting+Minuteshttps://wiki.nci.nih.gov/display/CTRP/10- 05-2011+CTRP+Meeting+Minutes CTRP Website Updates Dorian Account Migration Informed Consent documents with new submissions CTRP 3.6 New Features Demo

5. Summary of CTRP Amendments Call Oct 12. 2011 Full presentation is available on the CTRP Wiki site

6. What to Submit Going Forward – Required Documentation Revised protocol document showing the changes since the last submission; or Revised protocol document and the document that was sent to the IRB, clearly indicating these changes and/or a document that lists all changes since the last submission (i.e., change memo )

7. When to Submit – Going Forward Timelines for Reporting Amendments All amendments are to be submitted within 20 days of the approval of the change in the protocol by the institution’s IRB. -An amendment submission is to include all changes to the clinical trial since the registration or last amendment submission. NCI ‐ designated Cancer Centers should develop processes and begin regularly submitting amendments by March 2012. -But, it is to everyone’s advantage to begin submitting amendments as soon as possible to avoid developing a backlog of amendments. (This section is grayed out)

8. When to Submit – Dealing with the Backlog Timelines for Reporting Amendments All amendments are to be submitted within 20 days of the approval of the change in the protocol by the institution’s IRB. -An amendment submission is to include all changes to the clinical trial since the last submission. (This section is grayed out) NCI ‐ designated Cancer Centers should develop processes and begin regularly submitting amendments by March 2012. -But, it is to everyone’s advantage to begin submitting amendments as soon as possible to avoid developing a backlog of amendments.

9. How to Submit – Dealing with the Backlog Multiple Amendments for One Trial CTRP recognizes that many centers that have been working very long and hard with trial registrations (Pilot Sites, Early Adopters, etc) and will potentially have a greater backlog of amendments on trials registered in CTRP If there is more than one amendment pending on a trial since original registration, we propose one of the following: -Individually submit each amendment for each trial via the usual Registration interface, Batch Upload, Web Services or -Submit using the Batch Upload and combine all the documents into a single doc or pdf and attach as type “other” -Submit the most current protocol, a change memo (a memo sent to the IRB listing these changes will suffice), via usual route and then send an email to CTRO (NCICTRO@nih.gov) clearly indicating the trial(s) and attach any intermediate change memos.NCICTRO@nih.gov

10. NLM Presentation ClinicalTrials.gov: Overview of Recent PRS Updates Nicholas Ide, MS Chief Architect, ClinicalTrials.gov (contractor)

11. New Responsible Party Format - Background Responsible Party (RP) -Sponsor [only one per trial] IND/IDE holder; if none, then Person or entity who “initiated” the trial −Funding recipient if grant or sponsored research agreement −Funder if procurement funding agreement (contract) -Sponsor may designate the Principal Investigator (PI) as RP [only one per trial] If PI meets certain requirements (e.g., has access to and control over data, right to publish) * http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf

12. New Responsible Party Format – Background Old Format -Allowed a Sponsor to “designate” a Principal Investigator as the Responsible Party, without any acknowledgment by the PI -A Principal Investigator designated by the Sponsor did not have “control” over the record -Sponsor-Investigators required Individual Accounts to be identified as Sponsor Otherwise, Sponsor displayed as Investigator institution (not the Sponsor-Investigator)

13. New Responsible Party Format

15. Responsible Party must approve and release record If RP = Sponsor; no change in process −Administrator “releases” record; fewer data elements If RP ≠ Sponsor; new process −Investigator must be specified as a User in the PRS and name must be properly formatted (for public display) −Investigator “releases” record Administrator receives notification after release See: “Responsible Party FAQ” on PRS Main Menu under Help

16. PRS Updates Coming Soon PRS Updates coming November 8 -See now in PRSTEST, See “What’s New” for details Screens for Results Outcome Measures have been revised -- based on the Beta Add Outcome Measure. -More dynamic, hopefully easier. Printable forms for Results -Participant Flow, Baseline Characteristics, Outcome Measures, and Adverse Event modules Intended as communication tools to help sponsors and investigators understand the information needed to enter results – not for data entry. Problem Report Download -For administrators, there is now a "Download" link on the organization Problem Report screen – produces a CSV file

17. CTRP Account Migration

18. New NCI User Accounts for CTRP New user Accounts will be created in CTRP (NCI Accounts) The “caBIG Login” on the CTRP screen will go away and everyone will login through NCI NCI requires that accounts be access (and passwords changed) every 60 days. Accounts that are not accessed within the time period will be locked and “may” be delete after 30 days post inactivation. User will receive email notices prior to their 60 period reminding them to change their password.

19. Reminders Please remember to submit your Informed Consent Documents along with your registrations Templates -The templates need to be used “as is” for submitting trial information. -Some centers are trying to “modify” the templates (i.e. adding columns or different data elements) and are finding the batch-uploads aren’t working.

20. CTRP Useful Links CTRP Registration Site: https://trials.nci.nih.gov https://trials.nci.nih.gov CTRP 3.6 Registration Site User’s Guide: https://wiki.nci.nih.gov/display/CTRP/NCI+Clinical+Trials+Reporting+Program+Re gistration+Site+3.6+User%27s+Guide https://wiki.nci.nih.gov/display/CTRP/NCI+Clinical+Trials+Reporting+Program+Re gistration+Site+3.6+User%27s+Guide CTRP 3.6 Trials Registration Batch Upload Templates: http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources Frequently Asked Questions: http://www.cancer.gov/clinicaltrials/conducting/ncictrp/faqs http://www.cancer.gov/clinicaltrials/conducting/ncictrp/faqs CTRP Users Forum: https://cabig-kc.nci.nih.gov/CTMS/forums/ https://cabig-kc.nci.nih.gov/CTMS/forums/ CTRP User listserv: https://list.nih.gov/cgi-bin/wa.exe?A0=CTRP-USERS-L https://list.nih.gov/cgi-bin/wa.exe?A0=CTRP-USERS-L CTRP Services Documentation and Integration Instructions: https://wiki.nci.nih.gov/display/CTRP/trial+Registration+Service+Documentation https://wiki.nci.nih.gov/display/CTRP/trial+Registration+Service+Documentation

21. Questions!