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Create protocol


  • 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.


Partners HRC Informed Consent Templates
Partners HRC Protocol Summary Template
Protocol Outline Template Please note: this is an exhaustive list. Some aspects may not apply to your study.


Harvard X's Fundamentals of Clinical Trials
Good Clinical Practice and Study Management Basics
Introduction to Clinical Research at MGH

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

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