ºìÐÓÊÓƵ

To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the ºìÐÓÊÓƵ Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.

This Standard Operating Procedure (SOP) describes the procedures for review, and approval of a clinical protocol and amendments for clinical studies involving the CTRU. Attachment templates include:

A: Protocol Format Template, B: Protocol Implementation Checklist (Investigator Initiated), C: Protocol Implementation Checklist (Clinical Trials)

• Delegated clinical research team members will ensure the site has received critical study documents such as the protocol, consent template, the Investigator’s Brochure (if applicable), lab, pharmacy and/or other manuals (if applicable), Case Report Forms (if available), sample budget worksheet, and a draft contract after the Confidential Disclosure Agreement (CDA) has been executed by the Technology Commercialization Office.
• The PI, in collaboration with other research team members, will review the protocol and applicable study-related materials to assess the feasibility of conducting the study at this site (See Attachment A: Protocol Format Template, Attachment B: Protocol Implementation Checklist (Investigator Initiated), and Attachment C: Protocol Implementation Checklist (Clinical Trials)).

• Each sponsor's protocol received by the PI site, or protocol initiated by the PI, should describe the purpose, objectives, design, methods, and analysis of a clinical study. It should be sufficiently detailed so the study can be conducted accurately and properly.
• Since it also outlines the ethical, clinical, and regulatory responsibilities of both parties, it acts as a contract between the PI and the sponsor. Therefore, the PI site should ensure the protocol can be properly executed by the CTRU.

• Each protocol will be reviewed by the PIs, coordinators, and other relevant Investigator site staff to ensure that:
  • The study is safe.
  • The study is good medical science.
  • The study is ethically acceptable.
  • The objective is clear and the study design, sample size, procedures, and statistical analyses will enable the objective to be met.
  • The protocol satisfies this Standard Operating Procedure (SOP) and GCP.
  • The protocol is financially and practically feasible for the CTRU.
  • CTRU has enough potential study subjects that would meet the protocol requirements.
  • CTRU has sufficient staff to conduct the study.
  • CTRU has the proper resources and equipment to conduct the study.
• All protocols for the CTRU must be reviewed and approved in this manner before agreeing to perform the study for the PI or Sponsor.

4. Protocol Amendement: