DF/HCC IND Safety Reporting Policy Updates - Effective September 1, 2025

September 01, 2025

Dear DF/HCC Community,

The DF/HCC Policies for Human Subject Research listed below have been revised and will go into effect on September 1, 2025. Research teams may start implementing the updated version 14 of RCO-204 as early as July 21, 2025.

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

Please review this message in its entirety for a summary of key revisions and important operational resources to support the implementation of these updates.

Summary of Key Policy Updates

RCO-204: Safety and Event Reporting (Version 14)

  • Section 5.2. IND Safety Reports
    • Reformatting of IND Safety Reporting (INDSR) policy section to clearly delineate the responsibilities of the sponsor vs. investigator related to INDSRs, also emphasizing that when a DF/HCC investigator holds the IND and serves as Sponsor-Investigator, they hold both sponsor and investigator responsibilities.
    • Sub-sections now clearly outline review and reporting responsibilities as tied to each specific role as they apply to DF/HCC investigators.
  • Section 5.2.2. Sponsor Responsibilities Related to INDSRs
    • Apply to DF/HCC investigators that hold the IND and are serving as the Sponsor-Investigator.
    • 5.2.2.3.1. Clarifies the reporting timeline for Sponsor-Investigators to notify the FDA within 15 calendar days of determining the UAP constitutes a significant risk.
    • 5.2.6.1.2. New language clarifying that the Sponsor-Investigator does not need to duplicate reporting to the FDA for INDSRs received from external entities (e.g., drug manufacturers) that have already been submitted to the FDA.
  • Section 5.2.3. Investigator Responsibilities Related to INDSRs
    • Apply to DF/HCC investigators serving as the PI on an externally sponsored trial, or as the Sponsor-Investigator of an investigator-sponsored trial.
    • 5.2.3.3.1. Updated to allow for the delegation to qualified study team members, as defined in the updated DF/HCC Key: Delegation of Tasks, the review of INDSRs sent from external sponsors to identify those that are clearly indicated by the sponsor as UAPs.
      • Note that for DF/HCC investigator-sponsored trials, the Sponsor-Investigator may not delegate Sponsor responsibilities related to the review and assessment of INDSRs, as outlined in section 5.2.2.
  • Definition: Unanticipated Problems Involving Risk to Subjects or Others (UPRSO)
    • Updated to include common shorthand “Unanticipated Problem (UAP)” as is used throughout the policy.
  • Section 5.3. IDE Safety Reporting (UADEs)
    • New section added to clarify DF/HCC Investigator and Sponsor-Investigator safety reporting responsibilities for device studies under an IDE.

Additional Updated Documents

Early Implementation of RCO-204 Version 14

  • Researchers may begin implementing version 14 of RCO-204: Safety and Event Reporting, along with the updated version of the DF/HCC Key: Delegation of Tasks as of July 21, 2025. Teams who choose to implement prior to September 1, 2025 should retain this Note to File with their regulatory documents.

Implementing New Version of the Key: Delegation of Tasks

  • Principal Investigators that choose to apply the updated Key: Delegation of Tasks; Version: July 21, 2025 (including the additional delegated responsibilities to the Coordinator role) to their active DF/HCC Delegation of Authority Logs, may utilize this Note-to-File Template by signing and retaining it with their regulatory documents in lieu of individually updating each existing DOA log with the new version of the Key.

Office Hours Educational Webinar – Review of Updated INDSR Policy and Workflows

DF/HCC leadership has determined that no formal documentation of training is required. However, an educational Office Hours was held to provide additional guidance and support for research teams on July 29th, 2025. View the webinar recording and slides from this session: