One of the most important documents that must be drafted before beginning a clinical trial is the study protocol. The study protocol acts as a roadmap for clinical sites, principal investigators, and regulatory agencies. There are many documents that are included in an Investigational New Drug (IND) application and the sponsor or contract research organization (CRO) of the clinical trial is typically responsible for writing the study protocol. Federal guidelines outline the basic requirements for a protocol, however, there are several strategies that sponsors and CROs can employ to improve the study design and safeguard against potential barriers.
This white paper will cover:
- Notable sections of a study protocol
- Consideration for the study review process
- The qualities of an excellent protocol
