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:
- 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?
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/
NSU New Protocol Form http://www.nova.edu/irb/manual/forms.html
REDCap database administrator David Bloyd firstname.lastname@example.org 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.