Getting Started Set Up Conduct Close Next Steps

Turning your grant proposal into a clinical research protocol will require adding details that are not commonly included in funding applications.

Typical protocols contain the following details about the proposed study:

  • Background and significance
  • Specific aims
  • Subject selection
  • Subject enrollment
  • Study procedures
  • Biostatistical analysis
  • Potential risks and discomforts
  • Potential benefits
  • Monitoring and quality assurance procedures
  • References
  • Study schematics
  • Appendices

Be sure to meet with a statistician for support with developing your analysis plan. The Massachusetts General Hospital Division of Clinical Research (DCR) offers biostatistics consultations to support you in this process. Please see below for links to this and other resources provided by the DCR and our affiliated institutions.

Once you have completed your protocol, you must submit it, along with your protocol summary, recruitment materials and informed consent forms, to the Institutional Review Board (IRB) for approval prior to study implementation.

Your IRB-approved protocol is the detailed template to be followed by you and all study staff members 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 Health Care and Good Clinical Practice (GCP) regulations. It is the basis for audits by the Partners IRB and federal agencies.

Learn More

The DCR at Mass General helps to connect investigators and study staff members to a variety of courses, services and resources that provide assistance with every step of the clinical research process. These include offerings from the DCR itself, as well as associated research institutions and organizations. Mass General resources are listed first; DCR programs are noted in parentheses.

Resources

Courses

ONLINE:

LIVE TRAINING:

Additional Support

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