21 Code of Federal Regulation (CFR) Part 50 – Protection of Human Subjects
21 CFR Part 54 – Financial Disclosure by Clinical Investigators
21 CFR Part 56 – Institutional Review Boards (IRBs)
21 CFR Part 312 – Investigational New Drug Application
These regulations define what is required by the U.S. FDA and cover the responsibilities of sponsors, investigators and Institutional Review Boards (IRBs). Other countries have their own requirements.
In addition, you must be familiar with good clinical practice (GCP), which refers to the principles and processes you are expected to follow. Compliance with GCP ensures that the rights, well-being and confidentiality of study subjects are protected. It also assures the collection of reliable data for submissions to regulatory agencies.
In addition, someone in your practice will need to assume the role of clinical research coordinator (CRC), or you will need to hire a coordinator. A CRC handles the management and documentation of the trial.
Required documents for an investigational new drug (IND) trial in the United States include:
- Confidential disclosure agreement (CDA)
- Form FDA 1572
- Protocol, amendments and signature page
- Investigational drug brochure (IDB), also called investigator’s brochure
- Curriculum vitae for the principal investigator (PI) and subinvestigators
- Investigational review board, (IRB)/independent ethics committee (IEC) approval letter and roster
- Laboratory certifications and normal ranges
- Investigator’s financial disclosure statement
Some of the information included in these steps is based on the book “Becoming a Successful Clinical Research Investigator” by Dr. David Ginsberg.