Clinical Research Support

Clinical Trials Education Office (CTEO)

Guide to Human Research Activities

The Guide to Human Research Activities outlines the current practices, policies and procedures involved in research trials at Dana-Farber/Harvard Cancer Center (DF/HCC). The guide is directed to those staff who are, or will be, directly involved with conducting research trials, including both medical and managerial/administrative staff. New research staff will find the material particularly useful as they become acquainted with their roles.

Guide to Human Research Activities (printable version pdf)

Guide to Human Research Activities

Preface and Acknowledgments

Preface and Acknowledgments

Description of Institutional Relationships

Description of Institutional Relationships

Introduction

Clinical Trials and Sponsorship

1.0 Clinical Trials and Sponsorship

Offices and Staffing Central to the Clinical Trials Process

2.1 Office for Human Research Studies (OHRS)
2.2 Quality Assurance Office for Clinical Trials (QACT)
2.3 Clinical Trials Education Office (CTEO)
2.4 Dana-Farber Cancer Institute (DFCI) Clinical Trials Office (CTO)
2.5 Massachusetts General Hospital (MGH) Cancer Center Protocol Office (CCPO)
2.6 Beth Israel Deaconess Medical Center (BIDMC) Cancer Clinical Trials Office (CCTO)
2.7 Clinical Investigations Leadership Committee (CLC)
2.8 Clinical Trials Operations Committee (CLINOPS)
2.9 Institutional Review Board (IRB)
2.10 Scientific Review Committee (SRC)
2.11 Scientific Progress Review Committee (SPRC)

The Study Team

3.1 Overall Principal Investigator (Overall PI)
3.2 Site Principal Investigator (Site PI)
3.3 Collaborating Investigators (Co-investigators)
3.4 Biostatistician
3.5 Research Nurse
3.6 Study Coordinators
3.7 QACT Data Analyst

Investigator and Study Staff Complaints and Suggestions

4.0 Investigator and Study Staff Complaints

DF/HCC Standard Operating Procedures (SOPs)

5.0 DF/HCC Standard Operating Procedures

Research Listserv

6.1 Subscribe to Research Listserv
6.2 Unsubscribe to the Research Listserv

Required Human Subjects Training

7.1 The CITI Program
7.2 Software Requirements
7.3 Courses
7.4 Certification
7.5 DF/HCC Training List
7.6 Continuing Education

Federal Guidelines for Research Involving Human Subjects

8.0 Federal Guidelines for Research Involving Human Subjects

Degree of Risk

9.1 Minimal Risk
9.2 Greater than Minimal Risk

Research Methods

10.1 The Drug Development Process
10.2 Pre-Clinical
10.3 Phase I
10.4 Phase II
10.5 Phase III
10.6 Phase IV
10.7 Multi-Modality Trials

Expanded Access to Investigational Treatment

11.1 Emergency Use
11.2 Treatment IND (Single Patient IND)

Tissue/Data Collection and Record Reviews

12.1 Banking Specimens and/or Data for Future Research
12.2 Access to Banked Tissue/Data by Other Investigators
12.3 Research Involving Previously Banked Tissue
12.4 Research Involving Record Reviews

Medical Devices

13.1 Definition
13.2 Ordering
13.3 Storage
13.4 Authorization
13.5 Dispensing
13.6 Destroying

Behavioral/Social Science Research

14.0 Behavioral/Social Science Research

Vulnerable Populations

15.1 Inclusion of Children as Participants in Research
15.2 Pregnant Women and Fetuses in Research
15.3 Cognitively Impaired Persons Involved in Research
15.4 Research Involving Prisoners

Recruiting Trial Participants

16.1 Private Medical Information
16.2 Referring Physicians
16.3 Advertisements
16.4 Recruitment Letters
16.5 Scripts
16.6 Unacceptable Language and Suggested Alternatives

Pre-screening Potential Trial Participants

17.1 Appropriate Information to Gather
17.2 Pre-screening Procedures

Protocol Design

18.1 The Protocol Document
18.2 Protocol Sections

Informed Consent

19.1 Informed Consent Document
19.2 Standardized Consent Form Template
19.3 Incentives and Renumeration for Study Participation
19.4 Assent and Children in Research
19.5 IRB Waiver of Informed Consent
19.6 IRB Waiver of Documentation of Informed Consent
19.7 IRB Monitoring/Auditing of the Consent Process
19.8 Guidelines for Obtaining Consent in Research
19.9 Instructions for Obtaining and Documenting Informed Consent of Non-English Speaking Subjects
19.10 Instructions for Obtaining and Documenting Informed Consent of Illiterate Subjects
19.11 Guidelines for the Protection of Cognitively Impaired Persons Involved in Research
19.12 Guidelines for Consenting the Pregnant Partners of Study Participants
19.13 DF/HCC Consent Form Footer

Protocol Submission, Review and Activation

20.1 The Review Process
20.2 Submitting a Trial for Review
20.3 Basic Elements of an IRB Submission
20.4 Other Documents that May Be Required
20.5 The Review Committees
20.6 Description of Protocol Reviewers
20.7 Review and Approval by other DF/HCC Departments/Committees
20.8 Notification of Board Actions
20.9 Review Outcomes
20.10 Response to Committee Requests
20.11 Claim of Exception
20.12 New Submission Flow Chart
20.13 Protocol Activation and Distribution

Continuing Review

21.0 Continuing Review

Amendments to Previously Approved Research

22.1 Overview
22.2 Types of Amendment Submissions
22.3 Amendment Submission Requirements

Protocol Deviations/Violations/Exceptions

23.1 Overview
23.2 Deviations and Violations
23.3 Exceptions

Unanticipated Problems Involving Risks to Participants or Others

24.0 Unanticipated Problems Involving Risks to Participants or Others

Serious Adverse Event (SAE) Reporting Policy

25.1 Definitions
25.2 Adverse Event Grading System
25.3 Attribution
25.4 DFCI IRB Requirements
25.5 SAE Reporting Form
25.6 Adverse Event/Expediated Reporting Systam (AdEERS)
25.7 SAE and IND/IDE Safety Follow-up Reports
25.8 Gene Transfer Reporting Requirements
25.9 PI-Initiated/IND Holder Reporting Requirements
25.10 PI-Initiated/Sponsor Holds IND Reporting Requirements
25.11 Industry-sponsored (Investigational) Reporting Requirements
25.12 Industry-sponsored (Commercial) Reporting Requirements

Privacy and Confidentiality

26.1 Health Insurance Portability and Accountability Act of 1996 (HIPAA)
26.2 What Constitutes PHI?
26.3 Minimum Necessary Standard for Research Activities
26.4 De-identified Information for HIPAA Privacy Rule
26.5 The Limited Data Set Option
26.6 Data Use Agreement Requirements
26.7 Accounting for Disclosures
26.8 Research on Deceased Persons
26.9 Waiver of Authorization for Research

Department of Biostatistical Science

27.1 Biostatistical Support for the Protocol Development Process
27.2 Biostatistical Support for Forms Development
27.3 Biostatistical Support for Data Collection and Storage
27.4 Biostatistical Support During Protocol Activation
27.5 Role of Biostatistics in Monitoring Active Trials
27.6 Biostatistics Involvement in Protocol Addenda
27.7 Analyses/Reports on DF/HCC Trials

Quality Assurance Office for Clinical Trials (QACT)

28.1 Introduction and Purpose
28.2 Mission
28.3 Functions of the QACT
28.4 Participant Enrollment in Clinical Trials
28.5 Randomization Process
28.6 Phase I Dose-escalation Studies
28.7 Single Patient IND
28.8 Non-protocol Volunteer Registration
28.9 DF/PCC Network Affiliate Registration
28.10 Industry-Led and Cooperative Group Registration
28.11 Non-patient Volunteer Registration
28.12 Electronic Confirmation of Registration
28.13 After-hours Registration
28.14 Removing a Participant from a Research Study
28.15 Protocol Closure Notification
28.16 Protocol Completion/Termination Notification
28.17 Reports Available from the QACT
28.18 Protocol Accrual Monitoring
28.19 Case Report Form (CRF) Design
28.20 Documentation and Storage of Data
28.21 Accrual-monitoring Program
28.22 Internal Auditing
28.23 DF/HCC Data and Safety Monitoring Board (DSMB)
28.24 DF/HCC Data and Safety Monitoring Committee (DSMC)

Clinical Trials Education Office (CTEO)

29.1 Programs for Clinical Investigators
29.2 Programs for Study Team Members
29.3 Professional Certification of Study Team Members
29.4 eLearning Center
29.5 In-Services

NCI Investigator Registration and Renewal

30.0 NCI Investigator Registration and Renewal

Protocol Registration Requirements

31.1 ClinicalTrials.gov
31.2 Clinical Trials Reporting Program (CTRP)

Principal Investigators (PIs)

32.1 General Responsibilities of the PI
32.2 Financial Disclosures by Clinical Investigators
32.3 Conflict of Interest Policy

Study Coordinators

33.1 Roles and Responsibilities
33.2 Protocol Management
33.3 Data Management
33.4 Drug Accountability
33.5 Regulatory Submissions
33.6 The Regulatory Binder
33.7 Research Sampling
33.8 Monitoring and Audit Preparation
33.9 Checklist for Monitoring and Auditing Visits

Investigator-held INDs

34.1 IND Overview
34.2 General Principles of the IND Submission
34.3 IND Content and Format
34.4 Submission of the IND Application to the FDA
34.5 IND Application and Approval Process
34.6 IND Post-Approval
34.7 IND Protocol Amendments
34.8 IND Safety Reports for Investigator-held INDs
34.9 IND Annual Reports
34.10 Final Study Reports
34.11 Withdrawal of an IND Application
34.12 General Responsibilities of the Investigator-Sponsor
34.13 Selecting Participating Investigators and Monitors
34.14 Informing Participating Investigators of New Observations
34.15 Reviewing Ongoing Investigations
34.16 Record Keeping and Record Retention
34.17 Inspection of Records and Reports
34.18 Disposition of Unused Investigational Drug
34.19 General Responsibilities of Participating Investigators
34.20 Control of the Investigational Drug
34.21 Participating Investigator Record Keeping and Record Retention
34.22 Participating Investigator Reports

Conducting PI-initiated Multi-Center Trials as DF/HCC

35.1 Purpose and Function of Lead Site
35.2 Overall Principle Investigator Responsibilities
35.3 Lead Site Responsibilities
35.4 Participating Site Principle Investigator Responsibilities
35.5 Regulatory Binder
35.6 Staff Training
35.7 Central Participant Registration
35.8 Adverse Event Reporting
35.9 Data Collection
35.10 Quality Assurance
35.11 Site Communication
35.12 Drug Ordering
35.13 Inter-Institutional Agreement/Contract
35.14 Multi-Center Coordinating Committee

Gene Transfer Research (Recombinant DNA)

36.0 Gene Transfer Research (Recombinant DNA)

A.1 Code of Federal Regulations
A.2 Good Clinical Practice Guidelines
A.3 Medical Terminology, Dictionaries and Other Resources
A.4 Suggested Reading
A.5 Useful Web Sites

Commonly Used Abbreviations and Acronyms

Abbreviations and Acronyms

Glossary of Terms

Glossary of Terms

The materials in this Toolkit provide members with the documents they need to write compliant clinical research trials at DF/HCC.