202 Investigator Agreements with Sponsors/CRO
| Document Name: Investigator Agreements with Sponsors/CRO | Document Number: 202 | Revision Date: 25JUN2024 | Supersedes: 302.00 |
| 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 methods for the preparation, and /or review of contracts regarding Good Clinical Practice (GCP) issues between Principal Investigator (PI), site (Clinical & Translational Research Unit- CTRU) and Sponsors/Contract Research Organizations (CROs).
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 Sponsor-Provided Contract:
- The Principal Investigator (PI) reviews the contract with Ohio University stakeholders, including technology transfer, legal affairs, and the office of research and sponsored programs, to ensure it contains the responsibilities assigned to the PI site, indemnification language, budget information, and any other information required by the PI site's legal counsel. If no contract is provided by the Sponsor, the PI site provides an agreement to the Sponsor that covers the same elements.
2. Contact Elements for GCP and Other Responsibilities
- The following elements should be included in the contract to cover Good Clinical Practice (GCP) and other responsibilities:
- Sponsor's name and address.
- Protocol title with drug/device name, where applicable.
- A listing of the study, clinical, and legal responsibilities of the PI site.
- A statement of the Standard Operating Procedures (SOPs) to be followed: PI sites, Contract Research Organizations (CROs), Sponsor’s, or a combination of SOPs.
- Estimated start and finish dates for the study.
- Terms of payment, including terms for delays and termination of the study.
- Number of study subjects required to enter and complete the study, and the criteria for a "completed" (fully paid) study subject.
- Confidentiality agreement.
- Publication rights.
- Data ownership rights.
- Records retention.
- Indemnification.
- Rules for subject adverse reaction or injury reimbursements.
- Other legal issues.
3. Approval and Agreement
- Upon completion, all agreements must be reviewed and approved by the legal advisor for the PI site and the Investigator.
- All PI site studies must have a signed agreement before the study starts (defined as the entry of the first subject).
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: None
Appendices: None
Approver: Director, CTRU and Clinical Partnerships