Active-Study Record Management

The Regulatory Binder Tool is available to help study sites achieve and maintain regulatory compliance and adhere to high standards of practice in the conduct of research involving human subjects.

Each section outlines the regulatory documentation requirements, general guidance for organization and record keeping, and, when applicable, references to federal regulations and Good Clinical Practice guidelines.

Print-Ready Binder Instructions and Tabs

General Guidance for using the Regulatory Binder

• Tailor the binder to meet the needs of your specific protocol:

• The Regulatory Binder is a template. Include only sections pertinent to your protocol. Omit unused sections and add sections as needed. See “Applicable sections” below for more information. If unsure what sections to include/exclude, contact the CHS Office.
• Organize and order the sections to facilitate easy use and reference, e.g., file most used and referenced sections in the front of the binder.
• Add additional tabs and/or documents to each section as needed.

• Keep the Regulatory Binder current and up-to-date.

• Identify an individual(s) responsible for maintaining the binder. Ensure that this person is on file with the IRB as an Additional Person to Contact to ensure that all IRB correspondence and documents are received/filed in a timely manner.

• Store binder in a safe and secure location, but accessible to study staff at all times.

• Participant-specific documentation and information, e.g., signed consent forms, test results, and completed case report forms, should be maintained separately in participant-specific binder/file.

What sections apply to your research protocol

Depending on the nature of the research, some tabs may or may not be required. Use the below list of links to each available tab template to ensure that the applicable sections are maintained. For questions, contact the CHS Office.

1. Human Research

a. Protocol

b. IRB

c. Consent Forms

d. Data Collection

e. NIH

f. Sponsor

g. DSMB

h. Training

i. Local Ethical Review

j. Scientific Review

k. Other

2. FDA-regulated Human Research (e.g., IND, IDE).
In addition to #1 above (Human Research), maintain the below tabs:

a. Logs

b. Investigator’s Brochure/Device Manual/Package Insert

c. Drug/Device

d. FDA

3. Good Clinical Practice.
In addition to #1 above (Human Research), maintain the below tabs:

a. CVs

b. Licensure

c. Investigator’s Brochure/Device Manual/Package Insert

d. Laboratory Documents

e. FDA

 

Updated: 27-Jan-2010