Designing Clinical Trial Protocol
The protocol is a detailed plan with instructions for the conduct of the clinical trial. All personnel involved in conducting study procedures will use the protocol as a guidebook. Consider all elements of the protocol, starting with a protocol schema. There are questions to think about when designing a protocol:
- Have you formulated a research question with one primary objective? (your sample size is typically determined using the primary objective)
- Have you conducted a thorough literature search to determine what research has been conducted on your topic of interest and how has it been conducted?
- Have you discussed your research protocol with the biostatistician to determine sample size?
- Do you have a budget with adequate funding for the duration of the trial?
- Do you have the time and resources (personnel, facilities, equipment) to implement the protocol?
- Do you have access to the study population for recruitment?
- Are you able to provide the adequate health care to a subject for any adverse events and unanticipated problems related to the research?
- Are you aware of the federal and state laws, codes of ethics, and good clinical practices that may affect study design and implementation?
Principle Investigator "How-To" Guide for Clinical Research at NSU can be found here.