Clinical Research Operations

POLICY TITLE: Guidelines for Development of Regulatory Binders/Files

POLICY STATEMENT:  A regulatory file/binder will be kept for all clinical trials in each branch/research
unit. The system for maintenance of these files will be developed at the branch or research unit level, but will meet the standards set forth in the Center for Cancer Research (CCR) SOP on Guidelines for Development and maintenance of Regulatory Files/Binders.

SCOPE:  The policy applies to all studies conducted or coordinated by the Center for Cancer Research
(CCR) Teams.

CONSIDERATIONS/REFERENCES/DEFINITIONS:  Federal Regulations require documentation of all
study-related activities. The regulatory files and subject records serve as documentation of a site’s
compliance with standards of Good Clinical Practice (GCP) and Federal regulations.

Definitions:

ICH/GCP Definitions:

• Documentation: All records, in any form (including written, electronic, magnetic, radiographic and
  optical) that describe the methods, conduct and/or results of a trial, the factors affecting a trial and the actions taken.

• Essential Documents: Documents that individually and collectively permit the evaluation of a conduct of a study and the quality of data produced. These documents serve to demonstrate the compliance of an investigator, sponsor or monitor with the standards of GCP and all applicable regulatory guidelines.

REGULATIONS/GUIDELINES:

21 CFR:

• 21 CFR 312.60 General Responsibilities of Investigators
• 21 CFR 312.62 Investigator Record Keeping and Record Retention
• 21 CFR 312.68 Inspection of investigator’s records and reports

FDA Bulletins:

• Oct 1995 Recordkeeping in Clinical Investigations
• May 1997 International Conference on Harmonization; GCP Consolidated Guideline

RESPONSIBILITY:  The responsibility for maintaining a regulatory file/binder at the point of care is the
Principal Investigator’s. This task is usually delegated to members of the Research Team, including the
Research Nurse/Protocol Coordinator and Data Manager. Each branch/research unit must ensure that
the standard is met as defined.