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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 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    

General Administration

Training and Education

  1. ET-201 New Clinical Research Staff Training
  2. ET-202 Responsibilities of the Research Team
  3. ET-203 Documenting Study-Specific Training 

Study Start-up

  1. SS-301 National Registration of Clinical Trials
  2. SS-302 Site Qualification Visit 
  3. SS-303 Preparation for a Site Initiation Visit (SIV)
  4. SS-304 Protocol Start-Up (pending)
  5. SS-306 Enrolling Clinical Research Subjects onto Secondary Studies

Project Management

  1. Source documents and research records
  2. Study medications/devices/treatments
  3. Regulatory

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Subject Management

Serious Adverse Event Reporting

1. AE-601    DF/HCC Procedures for Identifying, Documenting, and Reporting Adverse Events

Quality Assurance

  1. Registration
  2. Auditing / Monitoring
  3. Data Management

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Accreditation and Oversight

  1. QA-701 Responsibilities of Clinical Investigations Leadership Committee
  2. QA-702 Responsibilties of the Audit Committe
  3. QA-704 Responsibilities of the Clinical Research Operations Subcommittee
  4. QA-714 AAHRPP Accreditation Maintenance

HIPAA / Privacy Practices

  1. Safeguarding Personal Health Information (pending)
  2. Information Access Control (pending)

State and Federal Oversight

  1. OV-1001 Preparation for an FDA Inspection

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