- Making your grant proposal into a clinical research protocol will require adding details which are not commonly included in funding applications. Typical protocols contain the following: Background and Significance; Specific Aims; Subject Selection; Subject Enrollment; Study Procedures; Biostatistical Analysis; Risks and Discomforts; Potential Benefits; Monitoring and QA; References; Study Schematic; Appendices.
- Be sure to meet with a statistician for support in developing your analysis plan.
- Once you have completed your protocol you must submit it along with protocol summary and informed consent forms to the IRB for approval prior to study implementation.
- Your IRB-approved protocol is the detailed template to be followed by you and all study staff during the course of the study. Any changes to the approved protocol (subject recruitment, study procedures, data to be collected, etc.) must be IRB-approved before the change is implemented.
- Your approved protocol specifies how you will implement the study in accordance with Partners and Good Clinical Practice regulations. It is the basis for audits by the Partners IRB and federal agencies.
▪ Design and Conduct of Clinical Trials
▪ Good Clinical Practice in Research at an Academic Research Institution
▪ Operationalizing Clinical Research Protocols
▪ What Does the IRB Want?: How to Write a Human Studies Protocol