Notice of Clarification Regarding Clinical Trial Documentation Requirements for New Therapeutic Uses Investigators

Notice Number:


Key Dates

Release Date: December 17, 2014

Related Announcements




Issued by

National Center for Advancing Translational Sciences (NCATS)s


The purpose of this Notice is to alert New Therapeutic Uses applicants that in order to assure that the NCATS is supporting high quality clinical trials, the NCATS will establish a monitoring plan that is tailored to the risk and complexity of the study. To facilitate this goal, the NCATS Program Official will request that the awardee provide the following documents for Program information and assessment prior to any subject accrual or enrollment:

  • IRB-approved clinical trial protocol conforming to Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance (ICH GCP E6), identified by protocol title, version number and date, and including details of study design, proposed interventions, subject eligibility criteria and plans for assessing, managing and reporting adverse events and unanticipated problems
  • Documentation of IRB approval
  • IRB approved consent form, identified by version number, date or both
  • Plans for data and safety monitoring
  • Appropriate clinical trial participant risk information (the most current version of the Investigator’s Brochure).
  • Communication plan, including schedule of calls and reports to keep NIH appraised of study progress.

NCATS staff comments will be forwarded to the awardee within three weeks of receipt of the above package of information. The awardee must address all study design, operational and logistical issues, and safety, regulatory, ethical, and conflict of interest concerns raised by NCATS staff. The Notice of Award (NoA) will contain restrictive Clinical Terms of Award specifically addressing these issues. That is, no funds may be drawn down from the payment management system and no obligations may be made against federal funds for any research involving human subjects until the Program Official notifies the awardee that the identified issues have been resolved and a revised NoA is received.

This Notice applies to applicants to PAR-14-210, PAR-14-211, and PAR-14-212 and pertains solely to the clinical trials that are funded under the awards. Preclinical activities are not affected by this Notice.


Please direct all inquiries to:

Christine Colvis, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-451-3903