Policy Updates Effective January 3, 2023 - NEW Training Requirement for IND Holders

December 02, 2022

DF/HCC Research Community,

The DF/HCC Policies for Human Subject Research listed below have been revised and approved by DF/HCC leadership in accordance with ADM-100.

The approved Policy updates will go into effect on January 3, 2023.

Tracked changes have been posted to the DF/HCC website to facilitate notification and review: DF/HCC Policy Updates Page

DF/HCC leadership has determined that no formal documentation of training is required for the following policy updates.

Policy Updates

EDU-100: Training Requirements for Research Personnel

  • Section 5.5. Added a new training requirement for all investigators holding an IND for research submitted under DF/HCC.
  • Appropriate training on IND responsibilities and requirements will be provided by the investigator’s home institution, and documentation of completion must be provided to the Office of Data Quality (ODQ) for centralized tracking.

How to fulfill this new training requirement:

  • If an investigator has questions regarding prior completion of training and/or adherence to this policy requirement, they should reach out to their designated institutional contact.

Rollout and timing:

  • As of January 3, 2023: The policy update and training requirement will go into effect, and investigators/teams may begin to receive conditions noting this requirement for any pending or newly submitted studies.
  • As of March 1, 2023: Investigators must be in compliance with this requirement prior to activation of any newly submitted studies and/or amendments changing the IND holder for an existing study.

RCO-203: Regulatory Documentation

  • Section Language added to clarify that data stored in central DF/HCC systems (e.g., OnCore, iRIS, OncPro) are not considered part of the Trial Master File or Investigator Regulatory File. Regulatory documents must be separately filed in a distinct Trial Master File/Investigator Regulatory File.

Please contact ODQEducation@dfci.harvard.edu with any questions regarding this announcement.