206 Storage of Frozen Research Samples
| Document Name: Storage of Frozen Research Materials | Document Number: 206 | Revision Date: 12JUL2024 | Supersedes: 308.00 |
| Target Group: Research and lab Personnel | Approval Date: 20Dec2024 | Effective Date: 01Jan2025 | Training Required: -Bloodborne Pathogens Training |
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 the storage of frozen research samples at the CTRU.
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. Sample Storage:
- Labs that need to be stored in transfer vials per the protocol (both the vials and cryoboxes) will be labeled. Boxes will be labeled on the lid as well as the base. Minimally, investigator, protocol #, study name, and box number ____ of ____ should be on the box. Samples should minimally be labeled with sample type, participant ID, and date sample was collected.
- Samples will be placed in the cryobox and the corresponding grid will be labeled to allow for proper sample identification. The specific placement of samples within the box will be determined for each study and based on the study protocol.
2. Sample Retention:
- Sample retention will occur per study protocol. Length of sample retention will be determined by the primary investigator.
- Samples should have a plan for long-term storage, destruction, or transfer upon completion of the study.
3. Repository:
- Repositories are also known as registries, data banks, databases, and biobanks. A repository may contain materials prospectively collected from humans or may hold existing materials originally collected for other purposes. A repository designed for prospective collection of specimens from humans for research purposes and/or to maintain and distribute specimens/data (that are linked to identifiers) to researchers must have IRB approval and oversight. As such, to use the CTRU as a repository, the SOP 207 CTRU Biorepository should be followed.
Applicable Regulations, Guidance, and Policies
| Regulation | Title |
|---|---|
| 21 CFR 50 | Protection of Human Subjects |
| 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 |
| 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