The Center for Clinical Studies (CCS), with support from the Institute of Clinical and Translational Sciences (ICTS), can provide help in developing protocol documents for human subjects research studies. There is no fee for these services, and they include:
• Assistance with compiling a human subjects research plan into a written protocol to be used for IRB submission.
• Review of a protocol prior to IRB submission to ensure completeness.
• General protocol development questions and the need for an Investigational New Drug application (IND) or Investigational Device Exemption (IDE). Actual IND or IDE preparation costs may be charged back to the investigator’s grant, where appropriate.
• Referral to the CCS/ICTS-funded TrialCare unit for a multi-disciplinary consult.
If you would like help in creating a human subjects research protocol document, please contact our Regulatory Support Center at firstname.lastname@example.org