Here is what you need to know.

Regulations and Education

Documentation Requirements

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

Patient Safety

  • 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

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