203 Protocol Handling, Feasibility Review, and Approval
| Document Name: Protocol Handling, Feasibility Review, and Approval | Document Number: 203 | Revision Date: 25JUN2024 | Supersedes: None |
| Target Group: Research Personnel | Approval Date: 20Dec2024 | Effective Date: 01Jan2025 | Training Required: -Human Subjects Protection (HSP) -Good Clinical Practices (GCP) |
Purpose
To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University 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)
Responsibilities
The CTRU is responsible for developing, implementing, and maintaining SOPs. Creating new or revising an existing SOP is determined by changes to federal regulation, guidelines, institutional policies, or procedures. All applicable documents will be provided to departments and research teams conducting human subject research.
Procedures
1. Review of Critical Study Documents:
- 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)).
2. Protocol Content and Responsibilities:
- 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.
3. Protocol Review and Approval:
- 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:
- Amendments to the protocol can be suggested by the sponsor or the PI and can be made after the protocol is finalized if changes are necessary.
- The procedure for amendments is similar to protocol preparation. A draft amendment is prepared and reviewed internally and by PIs as described in section 3.
- The PI site must obtain IRB approval of the protocol amendment before implementation.
Applicable Regulations, Guidance, and Policies
| Regulation | Title |
|---|---|
| 21 CFR 50 | Protection of Human Subjects |
| 21 CFR 56 | Institutional Review Boards |
| 21 CFR 312 | Investigational New Drug Application |
| 21 CFR 812 | Investigational Device Exemptions |
| 45 CFR 46 | Protection of Human Subjects |
| 45 CFR 160 | HIPAA Privacy Rule |
| 45 CFR 164 Subparts A and E | HIPAA Privacy Rule |
| ICH E6(R2) | Guideline for Good Clinical Practice E6 Integrated Addendum |
| FDA Guidance for Industry | Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects, October 2009 |
| FDA Guidance for Industry | IRB Continuing Review after Clinical Investigation Approval, February 2012 |
| FDA Guidance for Industry | A Guide to Informed Consent- Information Sheet |
| FDA Guidance for Industry | Adverse Event Reporting to IRBs- Improving Human Subject Protection |
References: None
Attachments: A: Protocol Format Template, B: Protocol Implementation Checklist (Investigator Initiated), C: Protocol Implementation Checklist (Clinical Trials)
Appendices: None
Approver: Director, CTRU and Clinical Partnerships