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Investigator Responsibilities in Clinical Research
Amy K Feehan1, Julia Garcia-Diaz1,2
1Department of Infectious Disease, Ochsner Clinic Foundation, New Orleans, LA.
Ochsner Journal
|April 15, 2020
Summary
Principal investigators (PIs) are responsible for clinical trial integrity and compliance. Upholding Good Clinical Practice (GCP) and ensuring staff oversight are crucial for successful research and maintaining public trust.
Area of Science:
- Clinical Research
- Regulatory Compliance
- Investigator Responsibilities
Background:
- Clinical trials are essential for translating basic science into therapeutics.
- Principal investigators (PIs) must understand the critical nature of their roles.
- Adherence to regulations is paramount in clinical research.
Purpose of the Study:
- To review investigator responsibilities under federal regulations.
- To examine the implications of signing FDA Form 1572.
- To outline methods for enhancing compliance in clinical trials.
Main Methods:
- Review of the Code of Federal Regulations Title 21.
- Analysis of FDA Form 1572 content and requirements.
- Discussion of FDA inspection processes and compliance improvement strategies.
Main Results:
- PIs are ultimately responsible for study compliance, regardless of delegation.
- Noncompliance can lead to severe consequences, including FDA warnings, fines, or imprisonment.
- Maintaining integrity and oversight is key to navigating FDA inquiries.
Conclusions:
- Investigators must ensure high-quality research and uphold public trust.
- Effective staff training and supervision are vital for PI compliance.
- Adherence to Good Clinical Practice (GCP) standards ensures data quality and facilitates publication.
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