For lab using in clinical trial, there are some regulatory requirements stated in items 22、47、64 of China GCP (2003).

First of all, if local lab is to be used as required in the protocol, the facility and capabilities of the lab at the investigator site shall be thoroughly assessed at Site Validation Phase (all the lab parameters as specified in the protocol, which, by the time of the protocol finalization, would have been confirmed as essential elements for assessing efficacy or monitoring safety ).

If a site was selected for use, but without the capabilities to perform the protocol required tests, assurance shall be put into place, including but not limited to,

Ÿ   Consent and agreement from patients and IEC if different labs were to be used from the as pre-identified in the protocol/ICF.

Ÿ   Lab’s qualification in performing the tests

Ÿ   Timely accessible to the test results to ensure timely assessment of a patient’s safety from PI/INV

Ÿ   Consistent test methodology applied to the patient across the studies, or justification from science/analytics perspective

Ÿ   Lab qualification and source data would be accessible for verification (not only printout, but also E-data where lab reports were first generated)

Considering these commitments from the lab, the site is recommended to have a formal contract with the labs to be used. Where FDA 1572 applied, the sub-contacted lab shall be reported in FDA 1572.

Having said that, the evolvement of regulatory requirement and risk-based approach need put into consideration. Solutions/Mitigations shall ensure subjects’ safety, data integrity and compliance with regulations.