Some research studies will involve the collection and analysis of participant samples such as blood, urine, and tissue.
The procedures for sample collection, storage, transfer, receipt and analysis must be explicit in the protocol, and where it is not standard operating procedures/a sample management plan or a laboratory manual should be developed providing clear instructions to sites /laboratories on the requirements for the study prior to study initiation/activation. The Chief Investigator and/or Principal Investigator are responsible for ensuring that the sites /laboratories work to the currently approved version of the protocol and study procedures (i.e. informed of amendments)
All laboratory work must be performed in accordance with the protocol, GCP, and Good Laboratory Practice (GLP) at the laboratories own internal quality systems.