Starting Points

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.