NCI Clinical Trials Reporting Program CTRP User Meeting November 2, 2011 Gene Kraus CTRP Program...
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![Page 1: NCI Clinical Trials Reporting Program CTRP User Meeting November 2, 2011 Gene Kraus CTRP Program Director.](https://reader035.fdocuments.us/reader035/viewer/2022062421/56649ce35503460f949af361/html5/thumbnails/1.jpg)
NCI Clinical Trials Reporting Program CTRP User Meeting
November 2, 2011
Gene KrausCTRP Program Director
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• 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
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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
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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
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Summary of CTRP Amendments CallOct 12. 2011
Full presentation is available on the CTRP Wiki site
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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)
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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)
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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.
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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.
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NLM PresentationClinicalTrials.gov:
Overview of Recent PRS Updates
Nicholas Ide, MS
Chief Architect, ClinicalTrials.gov (contractor)
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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
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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)
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New Responsible Party Format
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New Responsible Party Format
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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
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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
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CTRP Account Migration
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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.
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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.
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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
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Questions!