The DF/HCC Policies for Human Subject Research listed below have been revised. In accordance with ADM-100, these changes were drafted by the Clinical Research Operations Committee and have been approved by DF/HCC leadership.
The approved updates are effective as of August 1st, 2019. The Policy and Operation Library has been updated with the current versions.
An updated Policy Training and Signature Record has also been posted - Please ensure that new staff use the updated version when documenting DF/HCC Policy training.
DF/HCC leadership has determined that no formal documentation of training is required for the following policy updates.
Summary of Updates
Updates to Policy Content and Requirements
RCO-100: Investigator-Sponsored Research
- Combined with RCO-101 (to be retired effective 8/1/19)
- Content, language and definitions expanded to include all DF/HCC investigator-sponsored research, including non-IND/IDE research
- Added language regarding requirements for investigators collaborating with external parties on DF/HCC-sponsored research
- Removed language on IND Safety Reports (moved to RCO-204)
- Procedural language about obtaining and maintaining and IND and IDE moved to two new DF/HCC Operations:
- RCO-OP-4: Obtaining and Maintaining an IND
- RCO-OP-5: Obtaining and Maintaining an IDE
RCO-204: Reporting Adverse Events
- Sections 5.13. and 5.14. Language regarding IND Safety Reports added (moved from RCO-100)
- Updated to clarify investigator responsibilities regarding IND Safety Reports for DF/HCC-sponsored research
- Section 5.4. Language revised to state that clinically significant test results must be documented as adverse events, but abnormal results that are not clinically significant are not considered adverse events.
RCL-100: Preparation for Site Close Out
- Revised to encompass all DF/HCC research rather than limited to FDA-regulated (IND/IDE) research
- Language reorganized and edited to clarify requirements for both investigator-sponsored and externally sponsored research
AUD-100: Audits and Inspections
- Section 188.8.131.52. Language added to clarify that DF/HCC is unable to host external sponsor or their representatives during on-site regulatory inspections
RCL-101: Record Retention for Completed Research
- Section 5.1. Language moved from previous section 5.5. to clarify investigator (or designee) responsibilities for teams without dedicated or centralized disease programs
Other New/Revised Documents:
- Requirements for DF/HCC Collaborations with External Parties (NEW)
- Transfer of Obligations Template (NEW)
- Regulatory File: Required Document List (REVISED)
Newly Retired Policies – Effective 8/1/19
- RCO-101 (Combined with RCO-100)
Please contact ODQEducation@dfci.harvard.edu with any questions regarding this announcement.