HCC Policy Updates Summary - Effective March 2026
March 26, 2026
Summary of Updates
REGIST-101: Subject Registration
- Sections 1 & 5.6. Language updated to clarify that ODQ must perform centralized randomization for all investigator-sponsored treatment protocols, and any exceptions allowing randomization to be performed outside of ODQ for these trials must receive approval from ODQ and HCC leadership. For other protocol types requiring randomization, ODQ may perform centralized randomization, provided that the request is approved by ODQ Director.
- Section 4.2. Definition of centralized randomization added.
- “DF/HCC” updated to “HCC” throughout.
RCO-203: Regulatory Documentation
- Section 5.2.2.4. added under 5.2 (Delegation of Authority Requirements) to clarify that research staff providing temporary coverage should be listed on the DOA only when required by local institutional policy.
- “DF/HCC” updated to “HCC” throughout.
The full summary is also available on the HCC Policy Updates page. The updated policies are now posted to the HCC Document Library.
Please contact ODQEducation@dfci.harvard.edu with any questions regarding this announcement.