Updated DF/HCC Site Management Plan - Now Posted!

January 12, 2023

The DF/HCC Site Management Plan (SMP) is a resource for study teams and sponsors outlining DF/HCC oversight, review, regulatory and reporting structure and requirements, per DF/HCC policies. 

An approved revised version of the DF/HCC SMP was on January 12, 2023.

Updates include:

  • Section 1.0: Oversight Responsibilities of the PI
    • Language updated to clarify that the PI of each participating DF/HCC site is responsible for reportable events at their site. While the regulations require each PI be responsible for ensuring appropriate IRB review of reportable events at their site, the DF/HCC Core Site will coordinate the submission of certain submissions (e.g., amendments, administrative modifications, CRs, etc)
  • Section 2.0: Institutional Review Board
    • Language updated to clarify that communication from OHRS, including but not limited to approval or acknowledgement letter will be sent to each site's PI. Note that iRIS has been updated to facilitate these types of communication be sent to each PI. 
  • Additional edits
    • Additional minor updates throughout to clarify responsibilities of each site PI.