Regulatory Information

GUIDELINES FOR CREATING A REGULATORY BINDER

General Guidance for Using the Regulatory Binder:

  • The Regulatory Binder should be assembled at the beginning of the study, before enrollment.
  • Keep the Regulatory Binder current and up-to-date.
  • Customize the binder to meet the specific needs of your protocol:
  • This Regulatory Binder is a template. Include only sections pertinent to your protocol. Omit unused sections and add sections as needed. See “Applicable Regulatory Binder tabs” below for more information.
  • Add additional tabs and/or documents to each section as needed.
  • Identify an individual(s) responsible for maintaining the binder. Ensure that this person is listed as the Primary Contact in the IRB system 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 authorized 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 a participant-specific binder/file. Study material containing identifiable information should be stored in a secure location or protected manner.
  • If documentation is maintained in a separate location or electronically, include a signed and dated note-to-file in the designated binder section explaining where the file is kept and who maintains them.

APPLICABLE REGULATORY BINDER TABS

1. General Research Studies
Examples include but are not limited to: Questionnaire studies, minimal risk drug studies

a. Protocol/Amendments+
b.Consent/HIPAA+
c. IRB/xIRB*+
d. Training+
e. Case Report Forms (CRFs)+
f. Lab+
g. Instructions for Use (IFU) +
h. Recruitment +
I. CV/Medical Licenses +
j. ParticipantMaterials +
k .Delegation Log+
l. Screening/Enrollment Log+
m. CLIA/CAP/ Lab Certificates +
n. Package Insert
o. Miscellaneous

2. FDA-Regulated Drug Studies
(in addition to #1, maintain the following tabs)
Examples include but are not limited to: Clinical trials, IND submission studies

a. Financial Disclosure ^
b. Study Shipment Supplies^
c. Monitor Log & Letters ^
d. 1572^
e. Investigator Brochure^
f. FDA Submissions^
g. Investigational Product Shipment^
h. Investigational Product AccountabilityLog ^
i. SAE/IND Reports (non-UPIRSO)^
j. SAE/IND worksheets^
k. Correspondence^

3. FDA-Regulated Device Studies
(in addition to #1, maintain the following tabs)
Examples include: Investigational device studies, IDE submission studies

a. Financial Disclosure ^
b. Study Shipment Supplies^
c. Monitor Log & Letters ^
d. FDA Submissions^
e. Investigational Product Shipment^
f. Investigational Product AccountabilityLog ^
g. Investigator Agreement^
h. Correspondence ^

4.Sponsored Research Studies
(in addition to #1, possibly #2 and/or #3, maintain the following tabs)
Examples include: Studies with external funding

a. Sponsor Contact
b. Sponsor Newsletters
c. (Sponsor)Correspondence

Comments
* external IRB (both commercial or non-commercial)
^ use to maintain documents required for FDA-regulated research
+ use to maintain documents to meet Good Clinical Practice (GCP)

FORM 1572

The 1572 is an investigator’s signed contract with the FDA, agreeing to uphold federal clinical study obligations. No investigator may participate in an investigation until a 1572 is signed. Device studies use an Investigator’s Agreement Form, which is the equivalent to the 1572.

The PI agrees to personally conduct or supervise the described investigation. The PI agrees to maintain adequate and accurate records in accordance with 21 CRF 312.62 and to make those records available for inspection in accordance with 21 CRF 312.68. The PI ensures that all associates, colleagues, and employees assisting in the conduct of the study are informed regarding their obligation to meet all commitments of the study.

  • Name and address of the investigator
  • Education, training, and qualifications of investigator
  • Address of research facilities and clinical laboratories
  • Name and address of the IRB
  • Name of co-investigators and research staff
  • Protocol number and title
  • Commitments
  • Signature
  • Date

GUIDELINES AND REGULATIONS

Federal Regulations

  • Code of Federal Regulations (CFR)
    • CFR Title 46 Part 46: Outlines federal policy for the protection of human subjects in research, establishing mandates for institutional review boards (IRBs) and additional protections for vulnerable populations.
    • CFT Title 21 Part 50: Specifies that research on human subjects at institutions that hold Federal wide Assurances (FWAs) requires IRB review; this CFR specifies the minimum level of review for different types of research.

International Guidance

  • International Conference on Harmonization – Good Clinical Practice (ICH GCP E6)

Local

  • Institutional (IRB) versus Central IRB (usually selected by sponsor but can be WIRB, Quorum or others)

INSTITUTIONAL REVIEW BOARD

The Institutional Review Board (IRB) was established in accordance with federal regulations governing the use of human subjects in research. 

The IRB reviews and surveys research to ensure the protection of the rights and welfare of all research subjects. 

Investigators cannot initiate or  change research protocols until they have received IRB approval.

GOOD CLINICAL PRACTICE TRAINING

All faculty or staff listed on a protocol with the IRB must have documentation of training (may be specific requirements at institution)

Required: CITI Web Based Training or other similar program

Required: GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA focus) is suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum.

Recommended: Clinical Research Coordinator (CRC)

CITI Program’s CRC course provides a foundational training specifically focusing on operational and regulatory elements necessary for the ethical conduct of clinical research, while at the same time it is specifically tailored for the needs of clinical research professionals. It offers learners a foundation that expands beyond but is directly connected to the Human Subjects Research (HSR) and Good Clinical Practice (GCP) ICH training.

ADDITIONAL TRAINING

  • Protocol specific training

    • Expectations for clinical and research specific procedures, such as laboratory assessments, EKG, vitals, etc.

    • Expectations for standardized and non-standardized study data collection methods or assessments, such as questionnaires

    • Sponsor specific training for EDC, Specialty assessments, diary training, specific assessment devices (these may take place at Investigator meeting but most often by additional training modules/webinars)

  • Shipment of Hazardous Materials (IATA)

  • Blood Borne Pathogens

HELPFUL RESOURCES AND LINKS