Specimen Management
Bio specimens collected for research purposes differ based on protocol requirements. All studies requiring the use of bio specimens must comply with all federal, state and local regulations. The types of bio specimens collected for studies will vary but must be collected as described in the protocol for quality assurance.
Listed below are items that may be required by the study sponsor to demonstrate adherence to the applicable regulations. Principal Investigators interested in completing investigator-initiated studies can use these same items as a checklist or guidance for consideration:
- Current CAP/CLIA (if using a local lab)
- Current signed/dated CV of the local lab director
- Local lab normal references
- Protocol containing detailed instructions for specimen processing and shipping and/or a lab manual
- Current training/certification for personnel processing and shipping
- Adequate materials used for specimen collection (lab kits/shipping materials provided by the study sponsor; if investigator-initiated, should include collection supplies and shipping materials, including boxes and shipping labels)
Regardless of the type of study, all bio specimens collected for research purposes are processed under the guidance of the Trinity Health Office of Research & Innovation – West Michigan. The Tissue Procurement Specialist is available for consulting purposes by simply submitting a consultation request. The Executive Director is also available for consulting related to the need for contracts and budgets.
Finally, all studies involving the use of bio specimens for research purposes must be approved by the Institutional Review Board (IRB). A full set of Bio Specimen policies is available for review by request.
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*A full set of Bio Specimen policies is available for review by request.