204 Clinical Study Operations
| Document Name: Clinical Study Operations | Document Number: 204 | Revision Date: 12JUL2024 | Supersedes: 304.00 |
| 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 procedures for clinical study operations at the CTRU. This procedure is intended to meet 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. PI or delegated personnel activities:
- Personnel Management:
- Assigns trained and dedicated personnel to manage each study.
- Ensures that each delegated personnel follows Standard Operating Procedures (SOPs) and standard methods for all clinical research activities to ensure GCP compliance and data quality.
- Organizes each study.
- Trains all investigators and staff in the proper conduct of each protocol.
- Study Conduct:
- Conducts patient recruitment for efficient patient enrollment.
- Ensures that each coordinator completes all paperwork accurately and completely.
- Ensures all case report forms (CRFs), source documents, and other study subject information are completed accurately.
- Ensures all study activities are performed correctly.
- Maintains secure drug records and storage, with the drug removed from storage only as needed for each subject.
- Maintains regulatory documentation files in a standard storage system.
- Manages all Institutional Review Board (IRB) interactions.
- Maintains all sponsor communications.
- Provides safe and secure storage of all completed study records.
2. Standards:
All staff members adhere to the same SOPs and data quality standards.
- SOPs:
- The PI maintains and follows a complete set of SOPs that meet or exceed FDA regulations and GCP guidelines.
- The SOPs are reviewed at least every two years and updated as necessary.
- Study activities are completed using standard methods and forms to ensure compliance and consistency.
- Training:
- All personnel complete a Human Subjects Protection (HSP) training program, including a GCP requirement.
- All staff members complete appropriate training programs, including clinical research procedures and SOP training.
3. PI Oversight:
- All investigators are trained in the protocol requirements and FDA requirements and responsibilities.
- Study records are stored per protocol. Study records are separated by Personal Health Information (PHI) and coded source documentation.
- All investigators will see the subject as required by the protocol and will sign the necessary documentation for each visit, including any source documentation or CRF they completed.
- The investigator will perform all investigator activities required by the protocol. Completion of some paperwork may be delegated by the principal investigator. If the visit requires, other delegated personnel may see the subject.
4. Investigational Product (IP) Storage and Management:
- All IP is received and inventoried upon receipt.
- The IP is stored at the study site unless the protocol indicates a need for other storage requirements. Other storage locations are at the discretion and approval of the CTRU Medical Director.
- When the IP is needed for a subject, the delegated personnel take the supplies for that subject and log them out of central inventory. If required per the protocol, when the subject returns the IP, it is returned to inventory and logged in.
- Regardless of where the drug is stored, the delegated personnel are responsible for complete accountability and storage of the drug supplies.
5. IRB Interactions
- All activities relating to a clinical study are reviewed and approved by a duly constituted IRB prior to the initiation of any study activities. The IRB also approves the informed consent form and any advertising used for subject recruitment to ensure that the rights and welfare of the subjects are protected.
- The PI notifies the IRB of the following occurrences:
- Any protocols before they are initiated.
- Changes in study activities or amendments.
- Receipt of progress reports from the sponsor, including adverse events and changes in the investigational drug information.
- Changes in advertising.
- Changes in the consent form or changes in the risk-benefit ratio that may require a change in the consent form.
- Periodic reports of study progress, at least annually.
- Completion of the clinical study and submission of a final study report.
6. Study Procedures
- Before each study begins, a training session is held at the PI's site to educate and inform everyone at the site about the requirements of the study and their roles and responsibilities regarding the study. Copies of the protocol and any forms used will assist in educating study personnel.
- Staff members operate according to GCP compliance, study consistency, and applicable SOPs.
- Periodic internal audits are conducted to identify deficiencies in the systems, and corrections are made.
7. Document Procedures
- A documentation system maintains and stores all regulatory and study-related documents. Current copies of the Curriculum Vitae (CV) of the PI and all staff are filed in this area. Current copies of licenses (e.g., medical, laboratory, etc.) are also filed. A complete list of required documents can be found in the documentation SOP.
- These records are made available for the sponsor to review during the study and placed in safe storage for the required retention period after the study.
- An annual QA audit will be performed to ensure procedure and facility compliance for continued acceptability by the sponsor.
- All staff will support the sponsor's requirement for confidentiality of their studies.
Applicable Regulations, Guidance, and Policies
| Regulation | Title |
|---|---|
| 21 CFR 50 | Protection of Human Subjects |
| 21 CFR 56 | Institutional Review Boards |
| 45 CFR 46 | Protection of Human Subjects |
| 45 CFR 160 | HIPAA Privacy Rule |
| 45 CFR 164 Subparts A and E | HIPAA Privacy Rule |
| 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 | Adverse Event Reporting to IRBs- Improving Human Subject Protection |
References: None
Attachments: None
Appendices: None
Approver: Director, CTRU and Clinical Partnerships