Study Assessment

Main Content

Protocol Development/Review


  • A clinical research protocol is a document that describes the background, rationale, objectives, design, enrollment criteria, methodology, data recording requirements, statistical considerations, and organization of a clinical research study.
  • The protocol details exactly how the study should be conducted and therefore sets uniform standards for study conduct, allowing researchers to combine data from multiple sites to reach valid conclusions.
  • Protocol review involves an assessment of the protocol to ensure that the study can be successfully completed considering the available resources and capabilities. 


  • Basic questions to ask during protocol review:
    • Why is the study being done? Review the background, objectives or purpose, and study design information in order to obtain a general idea of the study and the target participants.
    • How many people will be in the study, and who can participate? Review the inclusion and exclusion criteria to determine who qualifies for the study and who cannot. This information is critical to an accrual feasibility assessment.  
    • What tests and procedures will be performed, and how will information be gathered? Review the schedule of procedures, which outline the number and timing of study visits, in addition to the procedures and assessments performed at each visit.
  • Human Research Office protocol development guidelines


  • UMMC Protocol Template - Word (intranet)