HCC Operations Updates June 2026 - REGIST-OP-1 & Dose Open/Closures

The HCC Operation for Human Subjects Research listed below has been approved by HCC leadership in accordance with ADM-100. The approved changes to REGIST-OP-1 will go into effect today, June 29, 2026. No formal documentation of retraining is required. Additionally, a new process change has been implemented regarding Dose Open/Close form routing. 

View a full description of the updates, tracked changes, and additional guidance here: HCC Operations Updates June 2026. 

SUMMARY OF UPDATES

REGIST-OP-1: Subject Registration Procedures

• 3.3. Centralized Registration

  • 3.3.1. Clarifies that ODQ does not review Sponsor confirmation of registration and only requires a completed eligibility checklist and signed informed consent document.

  • 3.3.7. Updated to reflect current process for receiving electronic confirmation of subject registration.

• 3.4 External Site Subject Registration

  • 3.4.2. Clarifies that external site subjects are registered by research staff at the HCC Coordinating Center.

• 3.8 Re-registration of a Subject to a Protocol

  • 3.8.3. Guidance added to note that to re-register a subject to the same protocol, the protocol must either provide appropriate language that a subject may be re-enrolled, or prospective IRB approval must be obtained.

• 3.9 Transfer of a Subject Between Institutions/Sites *KEY UPDATE* 

  • 3.9.5. Study teams are no longer expected to complete fields in OnCore related to subject transfer documentation (e.g., current study site, transferred from date). ODQ will now complete all transfer fields in OnCore (with the exception of 3.9.5.1. outlined below). The designated research team at any involved HCC institution(s) is now only responsible for contacting ODQ at ODQ@dfci.harvard.edu and providing: 1) the completed Subject Transfer Form and 2) the signed HCC Consent (as applicable).

    • 3.9.5.1. Teams who have extensive experience in regularly documenting subject transfers in OnCore may continue to do so if they choose to, and ODQ can provide assistance as needed.

    • 3.9.5.2. Explains that if an external site subject is transferred to an HCC site, ODQ may temporarily reopen the protocol and then immediately close it when the transfer is completed.

• 3.10 Subject Replacement

  • 3.10.4. Guidance added to note that if a protocol does not allow for subject replacement, study teams may consider submitting an amendment to update the protocol language if they believe there could be multiple subject replacement occurrences. 

Process Change: Dose Open/Closures

An email to ODQ Activation is now automatically triggered when a Dose Open/Close form is submitted involving either an open and closure, or closure alone. ODQ then implements the closure(s) in OnCore prior to the operational reviews required for any subsequent dose opening. This change ensures that closures are processed promptly to avoid safety and quality errors.

The updated operations document is now posted to the HCC Document Library. A full summary is also available on the HCC Policy Updates page.

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