Aiming to provide direction to inspectors and other CDSCO officers for conducting inspection of clinical trial sites, sponsor or CROs' facilities involved in clinical trial and information to investigators, sponsors or CROs about procedures for inspection and follow-up of action, the Drug Controller General of India (DCGI) has issued guidance on clinical trial inspection.
The guidance covers the entire gamut of issues involved in the clinical trial inspection. It aims to verify GCP compliance to protect the rights, safety and well being of the subjects involved in clinical trial; to verify the credibility and integrity of clinical trial data generated; and to verify the compliance with various regulatory provisions as per Drugs & Cosmetics Rules.
The scope and extent of the programme covers all clinical trial sites and sponsor/CRO’s facilities involved in clinical trial of drugs including biological and medical device covered under Drugs & Cosmetics Act.
As per the guidance, inspection can be conducted before, during or after a clinical trial is completed. Inspection can be carried out as a routine surveillance or for any specific cause(s). Study may be selected for inspection based on, but not restricted to the criteria like: Nature of study; for regulatory decision based on clinical trial data; Data irregularities; Complaints; Vulnerability of subjects; and Number of CT including number of subject enrolled at a particular site.
The CDSCO HQ will issue instruction to the CDSCO Officers /Inspectors to conduct the inspection identifying the clinical trial, name, address, contact number of clinical trial site, sponsor/CRO’s facilities to be inspected. It may also identify the type and purpose of the inspection and provide background materials like study protocol, CRF, etc.
According to the new guidance, inspection of clinical trial site would generally be pre-announced to ensure availability of the investigator/sub- investigator and other personnel along with study records at the time of the inspection. The date of inspection and other arrangements would be finalised by the CDSCO Officers/Inspector(s) in coordination with the investigator /sponsor/CRO. Under some specific circumstances unannounced inspection of clinical trial sites can be carried out as per the direction of CDSCO HQ and the inspection of CRO/sponsor can be conducted without prior notice.
The inspection includes verification of essential documents to determine whether the trial related activities were in accordance with the protocol, GCP guidelines published by DGHS, Govt. of India and Schedule Y as well as other applicable regulatory requirements. When inspection is carried out after completion of the clinical trial, it will include comparison of data generated by the sponsor with source documents at the clinical trial sites and Case Record Form (CRF) in the investigator’s files. If it is a routine surveillance or “for cause” inspection of an ongoing clinical trial, the comparison will generally include source documents and CRF.