Writing a Clinical Research Study Protocol

GW provides free access to investigators for Protocol Builder that speeds the development of research protocols that
comply with IRB and regulatory standards. GW recommends investigators consider using Protocol Builder for projects that involve greater than minimal risk. Don’t forget to consult on biostatistical methods or study design at the GW Biostatistical and Epidemiology Consulting Service.

A protocol provides the scientific basis for proposed research. It also defines key elements of the research, such as the study objectives, the population to be studied, procedures to be followed, the evaluations to be performed, and an analysis plan. A protocol also describes various administrative aspects of the study such as safety management and regulatory issues, which are carefully considered by the IRB. A poorly written protocol can result in significant delays to IRB approval times for investigator-initiated studies.


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Benefits of Protocol Builder for Protocol Writing:

  • Structured, step-by-step guidance
  • Eliminates time-consuming tasks involved in protocol development
  • Multiple protocol templates and commonly used forms
  • Aids collaboration with fellow researchers
  • Confirms protocol completeness at a glance
  • Enforces institutional protocol requirements and regulatory practices


Other Resources

National Institutes of Health (NIH)

  • The NIH also has a cloud-based protocol development tool, which has templates for Phase 2 or 3 Clinical Trials and Behavioral/Social Science.
  • Research Involving Human Subjects. Researchers will need to create an account and profile. The templates are also available as word documents. NIH’s Institutional Review Board also has helpful protocol templates for IND, prospective data, secondary data, and repository studies.

Spirit Group

  • The SPIRIT group provides a number of helpful resources including a checklist and an e-protocol template system.


Have questions using Protocol Builder?

For training or assistance with Protocol Builder, please contact Training_CTR@gwu.edu.

For IRB or Research Compliance questions, please contact Office of Human Research at ohrirb@gwu.edu.

If you are affiliated with the GW Cancer Center, please contact Richard Lush at rmlush3@gwu.edu.