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 http://www.nia.nih.gov/research/dgcg/clinical-research-study-investigators-toolbox/startup

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 http://www.fda.gov/downloads/Drugs/.../Guidances/ucm073122.pdf

Statistical services at NSU http://www.nova.edu/cwis/hpdstatconsulting/

NSU IRB http://www.nova.edu/irb/

Instructions how to complete an initial IRB submission Form may be found on the IRB website http://www.nova.edu/irb/manual/forms/submission_form_instructions.ppt

NSU New Protocol Form (Submission Form for Initial Review) http://www.nova.edu/irb/manual/forms/newprotocolsubform.doc

Contact REDCap database administrator David Bloyd dbloyd@nova.edu 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 http://www.nova.edu/irb/manual/forms.html 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.