CLINICAL TRIAL INSPECTION PROGRAMME

CLINICAL TRIAL INSPECTION

    Clinical trial inspection programme generally covers all the sites of clinical trial and sponsor/ Clinical research organization (CRO) facilities involved in clinical trial of new chemical molecules including biologically active agent and medical device covered under Drug's & Cosmetic's Act.

Clinical Trial Inspection

Objectives:  

1. To verify the study with the Good Clinical Practice in compliance to protect the rights, safety and well being of the subjects involved in the clinical trial.
2. To verify the clearance and integrity of clinical trial data which are generated.
3. To verify the compliance with various regulatory decision as per Drugs & Cosmetics Act.

     The purpose of clinical trial inspection programme is to give direction to inspectors and sponsor for conducting inspection of site of clinical trial, activities of sponsor, investigator, monitor, audit involved in clinical trial and information to investigators, sponsor, clinical research organization about procedures for the inspection of clinical trial study. In the clinical research site an inspector is allowed to perform the inspection of the clinical trial site identification i.e. name, address etc. and the facilities of sponsor as well as CRO.

       Inspection is to be conducted before, during or after the end of research study. Inspection must be carried out as a routine surveillance. Actually clinical trial inspection is required to see the nature of clinical research study, regulatory function, data irregularities, participation of subjects in a proper way.

       The inspection consists of the verification of essential clinical research documents to determine all the activities is to be done in accordance with Good Clinical Practice (GCP), The Protocol, Schedule Y and another applicable regulatory requirements. After the completion of clinical trial, inspection is to be carried out to ascertain the comparison of data generated from the trial with source data which has been obtained from the information of the comparable drug which has been already marketed.