Clinical Research Support
Clinical Research Unit (CRU)
Policies and Procedures
Policies and Procedures
Introduction
Abbreviations
Glossary
Table of Contents
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 serves to address the common questions 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. OPRS letter for sponsors (IRB Assurance Letter): This letter is provided to sponsors as part of the regulatory package. The DFCI IRB does not release membership rosters. This letter addresses that request.
3. 21 CFR Part 11: Many sponsors are asking us to complete questionnaries regarding 21 CFR compliance of our electronic systems. The following letters should 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 Nancy M. Antonino [ 617-632-5188 or mailto:nantonino@partners.org].
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
General Administration
- SOP Submission Form (Word Doc)
Training and Education
- ET-201 New Clinical Research Staff Training
- ET-202 Responsibilities of the Research Team
- ET-203 Documenting Study-Specific Training
- ET-204 Human Subject Protection Training Requirements
Study Start-up
- SS-301 National Registration of Clinical Trials
- SS-302 Site Qualification Visit
- SS-303 Preparation for a Site Initiation Visit (SIV)
- SS-304 Protocol Start-Up (pending)
- SS-306 Enrolling Clinical Research Subjects onto Secondary Studies
Project Management
- Source documents and research records
- Study medications/devices/treatments
- Regulatory
- PM-402 Conducting PI-Initiated Multi-center Trials at DF/HCC -revised 5/21/08
- PM-405 Procedure for Change of Clinical Trial Principal Investigator -
- PM-407 Reporting Unexpected Events Deviations/Exceptions/Violations) to the IRB for Approved Protocols
- PM-408 Responsibilities of the Sponsor-Investigator
- PM-409 Regulatory Binder Management
- Lead Site Regulatory Binder Checklist (Word Doc)
- Non-Lead Site Regulatory Binder Checklist (Word Doc)
- PM-410 Policy for Updating CV & Medical Licenses
- PM-411 Protocol Specific FDA 1572 Form
- FDA 1572 Form Template (Word Doc)
- PM-412 Confidentiality of Industry Sponsored Research Protocols
- PM-413 Case Report Form Compliance
- PM-415 Note-to-File
- Note-to-file template (Word Doc)
- PM-416 Preparation for Study Closeout - NEW 6/13/08
- Study Closeout Checklist (Word Doc)
Subject Management
- SM-501 Obtaining Informed Consent in Human Research Studies -revised 5/21/08
- SM-502 Protocol Related Care for Study Subjects at a Non-DF/HCC Facility
- SM-503 Removing a Subject from a Protocol
- SM-504 Transfer of Study Subjects Between Institutions
- Subject Transfer Form (word doc)
- SM-505 Procedure for Non-patient Volunteers Participating in Clinical Trials
- SM-506 Documentation of Informed Consent
Serious Adverse Event Reporting
1. AE-601 DF/HCC Procedures for Identifying, Documenting, and Reporting Adverse Events
Quality Assurance
- Registration
- QA-711Eligibility checklist development and implementation
- QA-712 Subject Protocol Registration - revised 5/21/08
- QA-713 Centralized NCI Annual Registration
- Auditing / Monitoring
- QA-705 Responsibilities of Audit Subcommittee
- QA-706 Notifying DF/HCC of External Audits
- QA-708 Monitoring Phase I Dose Escalation for PI-Initiated Protocols - Revised 5/14/08
- QA-709 Monitoring Phase II Early Stopping Rule for PI-Initiated Protocols - Revised 5/14/08
- QA-710 Responsibilities of the Accrual Monitoring Subcommittee
- QA-718 QACT Data Monitoring
- QA-719 Audit Preparation and Response
- QA-720 Internal Auditing of Clinical Trials
- QA-721 Routine Monitoring by External Sponsors - NEW 5/14/08
- Data Management
Accreditation and Oversight
- QA-701 Responsibilies of the Clinical Investigations Policy and Oversight Committee (CLINPOC)
- QA-702 Process for CLINPOC Sharing Information with the IRB
- QA-703 CLINPOC Communication with DF/HCC Institutions
- QA-704 Responsibilities of the Clinical Research Operations Subcommittee
- QA-714 AAHRPP Accreditation Maintenance
HIPAA / Privacy Practices
- Safeguarding Personal Health Information (pending)
- Information Access Control (pending)
State and Federal Oversight
