Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare has released the guidance document on Clinical Trial Inspections
The purpose of this programme is to provide direction to inspectors/CDSCO officers for conducting inspection of site of clinical trial, sponsor / CRO’s facilities involved in clinical trial and information to investigators, sponsor/ CRO’S about procedures for inspection and follow up
of action.
This Clinical trial inspection programme will cover 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.
CRO’s facilities involved in clinical trial of drugs including biological and medical device covered under Drugs & Cosmetics Act.
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.
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.
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 following criteria:
1. Nature of study2. For regulatory decision based on clinical trial data
3. Data irregularities
4. Complaints
5. Vulnerability of subjects
6. Number of CT including number of subject enrolled at a particular site
