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Trial Samples

Some research protocols will involve the collection and analysis of participant samples (bloods, urines, tissue).  The data analysis of these samples may be used to monitor participant safety throughout a study and/ or provide endpoint data.  The requirements and risks associated with the sample/laboratory activities should be reviewed (risk assessed) during the sponsorship request process.  How the data from sample analysis will be reported and retained during and at the end of the trial should be clearly agreed (and documented) prior to study being initiated/activated.

The procedures for sample collection, storage, transfer, receipt and analysis must be explicit in the protocol,  and where it is not standard operating procedures/ 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 /Principal Investigator’s are responsible for ensuring that the sites /laboratories work to the current approved version of the protocol and study procedures  (i.e informed of amendments)

Local laboratories (that are attached to the hospital) may be used for sample analysis or samples may be transferred to an external laboratory for analysis.  Whatever the laboratory arrangements are for a study the appropriate contracts (with clearly defined delegation of responsibilities) must be executed prior to any laboratory activities commencing. 

All laboratory work must be performed in accordance with the protocol , GCP, Good Laboratory Practice (GLP) and to the laboratories own internal quality systems.  Laboratories that receive blinded data should be made aware of that so that the blind is not compromised.  Incidents and non-compliance regarding trial samples/laboratory activities should be reported according to Noclor procedures. 

The application to the REC should have set out any commitments for use of collected samples/tissues at the end of the trial (i.e whether the sample will contribute to biobanks or be disposed of in accordance with the ethical approval).