Starting Points

When 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:

Templates of study protocols and other essential documentation

Good Clinical Practice – is an international and scientific quality standard for designing, conducting, recording and reporting clinical trials. This standard is applicable to the trials that require human subjects’ participation. Review the GCP document before designing study protocol to comply with standards and regulations in clinical research

Statistical services at NSU


Instructions how to complete an initial IRB submission Form may be found on the IRB website

NSU New Protocol Form (Submission Form for Initial Review)

Contact REDCap database administrator David Bloyd to verify how you can use RedCap and create your user account.

Consider which HIPAA – related documents should be used in your future study. Visit the IRB website to access HIPAA Template Forms

Budget – schedule consultation with Office of Clinical Research team!

Plan a mandatory Good Clinical Practice Training for your study team.