General Guidance for Using the Regulatory Binder:
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)
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.
Federal Regulations
International Guidance
Local
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.
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.
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
FDA Forms and Instructions
Electronic Code of Federal Regulations
Feinberg School of Medicine Policy
Template Logs
Northwestern IRB Resources
References/Works Cited
Internal References
Standard Operating Procedures (SOP) Template/Example
Standard Operating Procedures for Clinical Research Courtesy of April Langhammer, Study Coordinator, University of Kansas