Here is what you need to know.
Regulations and Education
- Good Clinical Practices (GCP) and any other applicable regulations including parts 50, 54, 56 and 312 of the Code of Federal Regulations (CFR) Title 21. Additional educational resources can be found here.
- The appropriate use and storage of investigational product(s), as described in the protocol, Investigator’s Brochure, product information and other sources provided by the sponsor or CRO.
The required documents for an investigational new drug (IND) trial in the United States include a confidential disclosure agreement (CDA); Form FDA 1572; a protocol, amendments and signature page; an investigational drug brochure (IDB); a curriculum vitae for the principal investigator and sub-investigators; an institutional review board (IRB)/independent ethics committee (IEC) approval letter and roster; laboratory certifications and normal ranges; and the principal investigator’s financial disclosure statement.
Administrative and Infrastructure Information
- How Frenova will advise you of new studies
- Administrative processes
- Training requirements for the study
- Technology and software to be used for the study
- Staff and office space requirements for a clinical research coordinator and clinical research associates
- What happens during the pre-study visit
- Study budget and enrollment expectations
- The contract with the sponsor or CRO
- IRB approval documents and processes
- How to prepare for the site initiation visit
- How to enroll patients
- Protocol procedures
- How to prepare for a site audit
- Informed consent practices and requirements
- When deviations from the protocol are appropriate to eliminate immediate hazards to trial subjects
- When and how to report adverse drug reactions (ADRs) that are both serious and unexpected
- When and how to report new information that may adversely affect the safety of the subjects or the conduct of the trial