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Clinical Research Times

October 31, 2022

Dear Colleague:

NIH has implemented a new electronic Research Administration (eRA) Research Performance Progress Report (RPPR) submission system to validate clinical trial registration and results reporting. This submission system cross-checks with the ClinicalTrials.gov (CTgov) database, in order to evaluate consistency between RPPR submissions and their associated CTgov study registration. This month’s CR TIMES Feature Article describes the policies and requirements involved in this process, and provides information on existing strategies for harmonizing these databases to avoid RPPR and final reports issues and potential NIH funding interruptions or study delays due to discrepant or incomplete information.

Also check out:

  • “Things to Know”
    • On the using Boston University (BU) REDCap for electronic signatures and electronic documentation in drug or device research
    • On new and revised Human Research Protection Program (HRPP) Policies, including using BU REDCap for drug or device research, and reporting changes made to eliminate an immediate apparent hazard to subjects
    • On recent updates to the non-exempt consent form templates (Adult Consent Form, Parent Permission Form, and Parent Consent and Permission Form)
  • “Getting to Know ClinicalTrials.gov” on completing the “Study Description” section of a CTgov record
  • “The CRRO Corner” on upcoming trainings (Fundamentals in the Conduct of Clinical Research and Principal Investigator Role training) for AY22-23, as well as the Clinical Research Seminar and RPN calendars
  • “Dear IRB” for guidance on when IRB review is needed for modifications to survey questions in exempt research

Learn more at www.bu.edu/crtimes.

Matthew T. Ogrodnik, MS, CIP, Editor, CR TIMES
Director, Office of Human Research Affairs