Introduction
Abbreviations
Glossary
Regulatory Documents for Sponsors
General Administration
Training and Education
Study Start-up
Project Management
Subject Management
Serious Adverse Event Reporting
Quality Assurance
Accreditation and Oversight
HIPAA / Privacy Practices
State and Federal Oversight
Regulatory Documents for Sponsors
1. DF/HCC Site Management Plan: The site management plan addresses the common questions that sponsors raise regarding the DF/HCC structure such as the 1572 form, drug distribution and study oversight. This document should be provided to the sponsor early in the new protocol process as the regulatory package is being prepared.
2. OHRS letter for sponsors detailing DF/HCC IRB Procedures: This letter is located on the OHRS website. Click here
3. 21 CFR Part 11: Many sponsors are asking us to complete questionnaires regarding 21 CFR compliance of our electronic systems. The following letters should be provided to sponsors upon their request for documentation:
Partners 21 CFR Part 11 letter BIDMC 21 CFR Part 11 letter
For further information please contact Jomol Mathew (617-582-8506 or jomol_mathew@dfci.harvard.edu).
4. DEA Letters: We do not release copies of DEA licenses. Please refer to the attached letters to be provided to sponsors:
BIDMC DEA DFCI DEA MGH DEA
1. AE-601 DF/HCC Procedures for Identifying, Documenting, and Reporting Adverse Events