DF/HCC Research Community,
The DF/HCC Policies for Human Subject Research listed below have been revised and will go into effect on September 30, 2022.
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. However, we encourage all investigators and research teams to thoroughly review the summary below and the posted tracked changes.
Office Hours Webinar: View a recording of the informational Office Hours session and Q&A held on Wednesday, September 21 regarding these policy changes and other recent updates to DF/HCC resources: DFHCC Office Hours (9.21.22).
Summary of Policy Updates
RCO-204: Safety and Event Reporting
- Updated the requirement for documentation of expectedness to better align with recent changes to DFCI IRB policy.
- Clarified the expectations for timely review and documentation of adverse events.
- Added statement regarding review and use of central lab results when local lab results are used for patient care determinations.
MON-101: Research Conduct Oversight by External Sponsors
- Site qualification language updated to reflect changes to onsite tours and use of virtual tours.
- Updated expectations for monitors and monitoring visits, including receipt of monitoring reports and scheduling remote monitoring activities.
INV-103: Protocol Mandated Drug Taken at Home
- Updated to clarify that standard of care/ancillary medications provided by the sponsor typically do not require documentation of dispensation and return
- Language added to include pertinent information to be included in the drug diary, and clarify that both paper and electronic drug diaries are acceptable tools of documentation
COM-100: Research Oversight and Operations Committees
- Administrative updates to roles and responsibilities, and language added to clarify who appoints SRC chairs.
DATA-100: Data Management of Investigator-Sponsored Therapeutic Protocols
- Updated to clarify that ODQ and RIO are only able to provide central data management support when DF/HCC data capture systems are used.
DATA-101: Case Report Form Development
- Minor updates to bring policy language in line with current CRF development processes.
DOC-100: Research Subject Documentation
- Minor clarifications for how to correct a documentation error, and documenting sponsor/IRB approval of deviations, exemptions, and waivers.
EDU-100: Training Requirements for Research Personnel
- Minor edits to references, and to remove “interventional” from definitions as not used in policy.
MULTI-100: DF/HCC Investigator-Sponsored Multi-Center Research
- Minor grammatical and reference updates throughout.
RCL-100: Preparation for Site Close Out
- Minor clarifications throughout, including removing Research Nurse as responsible personnel and updating the definition of completed protocol.
RCO-100: Investigator-Sponsored Research
- Added a statement that the sponsor-investigator of research under an IND/IDE must submit new projects or changes to FDA prior to submitting them in iRIS for SRC/IRB review.
RCO-103: Confidentiality and Secondary Use of Research Information
- Added a statement that all research staff are responsible for ensuring that staff have appropriate access and that access be removed when an individual leaves or changes roles.
- Added that breaches of confidentiality should be reported to the appropriate Privacy Officer and the DFCI IRB, even if the study is under an external IRB.
- Clarified that data sharing restrictions do not apply to an established DSMB or similar committee specified in the protocol.
RCO-203: Regulatory Documentation
- Added definition for the delegation of authority, and updated examples of staff typically not listed to include phlebotomists, dermatologists and ophthalmologists.
REGIST-101: Subject Registration
- Updates to the required timing of subject registrations.
- Minor updates to clarify when summary accrual reporting is allowed
REGIST-200: Registration of Clinical Trials on ClinicalTrials.gov
- Minor updates to outdated references/links
Please contact ODQEducation@dfci.harvard.edu with any questions regarding this announcement.