104 Sponsor Interactions
| Document Name: Sponsor Interactions | Document Number: 104 | Revision Date: 20DEC2024 | Supersedes: 104.00 |
| Target Group: Research Personnel | Approval Date: 05OCT2015 | Effective Date: 01Jan2024 | Training Required: -Human Subjects Protection (HSP) -Good Clinical Practice (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 CTRU interactions with the Sponsor or Contract Research Organization (CRO). This procedure is intended to meet Food & Drug Administration (FDA) federal regulations and Good Clinical Practices (GCP) for clinical studies, where applicable.
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. Pre-study inspection visit:
- All staff reads the draft or final protocol. Each staff member prepares questions for Sponsor regarding protocol procedures, methodologies, participant eligibility criteria, required equipment, or any other study-related issues.
- Provide a tour of facilities, including equipment, exam rooms, and drug storage. PI introduces Sponsor to site staff, emphasizing their qualifications.
- Describe participant demographics and recruitment methods. Provide non-confidential examples of previous study source documentation.
- Provide requested study documentation: Signed protocol, PI and staff CVs, Investigator's medical license, signed FDA form 1572, and budget.
2. Initiation visit:
- All staff review the protocol with the Sponsor to ensure correct understanding of activities and methodologies. PI clarifies information in the Investigator's brochure if applicable.
- Staff prepare questions for the Sponsor regarding protocol procedures, methodologies, participant criteria, equipment requirements, or other study-related issues.
- Provide up-to-date regulatory file for Sponsor review. Review Case Report Forms (CRFs) with Sponsor. Confirm all lab supplies are complete.
- Discuss drug storage, dispensation, return, and dosing with monitor.
- Review Sponsor's method for adverse event reporting.
- Ensure Sponsor signs visit log.
3. Ongoing study visits:
- PI and staff prepare questions for Sponsor regarding protocol procedures, methodologies, participant criteria, and equipment requirements.
- Ensure all informed consent forms are signed, dated, and filed. Verify completeness and accuracy of CRFs and source documents. Maintain up-to-date drug logs and adverse event data.
- Verify IRB approvals and maintain documentation in regulatory file.
- Plan time with monitor to review study progress and discuss issues.
- Ensure Sponsor signs visit log.
4. Close-out visit:
- Ensure all informed consent forms are signed, dated, and filed. Verify completeness and accuracy of CRFs and source documents. Address any corrections needed on CRFs.
- Complete and update drug log. Arrange return of study drugs to Sponsor as per protocol.
- Confirm completeness of adverse event data.
- Ensure IRB approvals are up-to-date and documented. Maintain completeness of regulatory file documentation.
- Plan session to review study progress and address issues.
- Ensure Sponsor signs visit log.
5. Sponsor Communications
- Maintain regular communication with Sponsor and document critical conversations.
- Notify Sponsor upon enrollment of first participant.
- Provide weekly participant enrollment information upon request.
- Inform Sponsor promptly if there are questions regarding participant eligibility.
- Notify Sponsor according to protocol timelines if a serious adverse event occurs.
- Keep Sponsor informed of participant recruitment progress.
5. Contacts with Sponsor
- Document all phone conversations, emails, and correspondence, especially regarding protocol deviations or participant issues.
- Summarize discussions, if necessary, obtain the Sponsor's signature, and file in regulatory documents.
Applicable Regulations, Guidance, and Policies
| Regulation | Title |
|---|---|
| 21 CFR 50 | Protection of Human Subjects |
| 21 CFR 312 | Investigational New Drug Application |
| 21 CFR 812 | Investigational Device Exemptions |
| 45 CFR 46 | Protection of Human Subjects |
| 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 |
References: None
Attachments: None
Appendices: None
Approver: Director, CTRU and Clinical Partnerships