NCATS PROCESS FOR CTSA PROGRAM HUMAN SUBJECTS RESEARCH:
Consistent with NOT-OD-15-129, the NCATS process for Clinical and Translational Science Awards (CTSA) Program human subject research (HSR) applies to:
Relevant Notices:
PROCESS OVERVIEW:
Category 1 Studies
Applies to: Projects involving human subjects deemed by the Institutional Review Board (IRB) to be Greater Then Minimal Risk, meet the criteria for an NIH-defined Clinical Trial.
Requires: Entry of the study into the eRA HSS and official notification from NCATS of NCATs’ Prior Approval before the project can begin.
Category 2 Studies
Applies to: Projects involving human subjects that are deemed by the Institutional Review Board (IRB) to be non-NIH-defined Clinical Trial minimal risk or exempt (45 CFR 46) studies.
Requires: Entries of these studies in the eRA Human Subjects System (HSS) along with NCATS-specified documentation and email notification of NCATS are required before the project can begin. Note: NCATS does not require CTSA institutions to wait for NCATS approval to begin the study.
INSTRUCTIONS:
NCATS-New-Projects-with-Human-Subjects-Research-Addendum-and-Instructions-for-PIs-and-SOs-ver4.2
Comments and questions about this process?
Email: NCATSDOPAinquiry@mail.nih.gov
REQUIREMENT REMINDERS:
NCATS CTSA Program Quality Assurance/Quality Control (QA/QC) Group:
Purpose: The QA/QC Group meets bi-monthly to discuss processes, challenges and best practices related to ensuring the submission of successful CTSA-related information packages to NCATS (with a specific focus on submissions of pilots and K projects conducting research with human subjects). NCATS provided the following administrative supplement to UL1 grants to support a dedicated quality assurance/quality control position: NOT-TR-20-014 (expired September 10, 2022) and continues this type of support in the new CTSA funding opportunity (PAR-21-293). Funding by this supplement is not required to participate in the group. If interested in joining the QA/QC Group please reach out to Lauren Fitzharris (lauren.fitzharris@icf.com) to receive registration information for the meetings, be added to the QA/QC Listserv, and have access to the QA/QC Group Discussion Forum. Click here to get started with the NCATS CTSA Program Quality Assurance/Quality Control (QA/QC) Discussion Forum.
Information related to this group (meetings, FAQs, etc.) can be found on the QA/QC Group Shared Drive (Log in is required). If you have issues with accessing the shared drive, please contact support@ctsa.io
CTSA Quality Assurance/Quality Control Group Frequently Asked Questions (FAQs)