The development of a well-written protocol is critical when undertaking a clinical research study. The protocol document describes the framework under which the study is conducted.
A well-written protocol must:
- State the rationale and objectives for the research;
- Describe the study design and methodology to be utilized;
- Define the study population;
- Protect participants’ rights while in the study;
- Outline the procedures to be followed throughout the course of the study;
- Present data monitoring, management and analysis plans to ensure high quality data;
- Describe the procedures for submitting reports to institutional review boards (IRBs), data and safety monitoring boards (DSMBs), and/or sponsoring institutions.
Review and approval by DMID is required for all protocols conducted under its sponsorship. The extent of review varies, depending on the complexity of the study design, and the assessed risk of participation including the nature of any interventional treatment or procedure, and specific reporting requirements for investigational or new drugs, products or agents.
Institutional review board (IRB) approval of all clinical research studies involving human subjects is required at each institution engaged in the research. [See Engagement of Institutions in Research published by Office for Human Research Protection.] Studies funded by DMID frequently require review by at least two IRB’s, an institution in the host country and that of a U.S. partner. IRB approval must be obtained prior to subject enrollment.
View presentations from past ICSSC events for information on Protocol Development.