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

NCI Clinical Trials Reporting Program CTRP User Meeting

November 2, 2011

Gene KrausCTRP Program Director

• 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

CTRO Metrics

• Metrics for period October, 2011- Original submissions 215- Amendments 34

• Metrics January 2009 to date- Original Submissions 5435- Accepted 4595- Abstracted 3917- QC 2887- Trial Summary Report Sent 2518

• Abstraction Verified 637

- Submitted amendments 559

October Review

• User call – October 5th • Minutes:

https://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

Summary of CTRP Amendments CallOct 12. 2011

Full presentation is available on the CTRP Wiki site

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)

When to Submit – Going ForwardTimelines 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)

When to Submit – Dealing with the BacklogTimelines 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.

How to Submit – Dealing with the BacklogMultiple 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 ([email protected]) clearly indicating the trial(s) and attach any intermediate change memos.

NLM PresentationClinicalTrials.gov:

Overview of Recent PRS Updates

Nicholas Ide, MS

Chief Architect, ClinicalTrials.gov (contractor)

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

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)

New Responsible Party Format

New Responsible Party Format

New Responsible Party Format

• 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

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

CTRP Account Migration

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.

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.

CTRP Useful Links

• CTRP Registration Site: 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+Registration+Site+3.6+User%27s+Guide

• CTRP 3.6 Trials Registration Batch Upload Templates: http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources

• Frequently Asked Questions: http://www.cancer.gov/clinicaltrials/conducting/ncictrp/faqs

• CTRP Users Forum: https://cabig-kc.nci.nih.gov/CTMS/forums/ • CTRP User listserv: 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

Questions!