- An inspection or audit of clinical trial site/s may be conducted by NMRA before or after the approval of a clinical trial.
- The aim of the inspection is to evaluate the acceptability of clinical data submitted to NMRA, and to ensure that legislation, on Good Clinical Practices (GCP) and Good Clinical and Laboratory Practice (GCLP) principles are in place as per the ICH-GCP Guidelines.
- The nominated members from CTEC or responsible officer of NMRA may contact the PI or sponsor for the date of inspection when required.
- However in the case of complaints or reports of unexpected adverse reactions, inspections may take place at short notice or may be unannounced.
(Refer details for conduct of GCP inspection – GL -028 Guideline on GCP inspections).