Functionalities of Global Clinical Trials Division.

• Processing of applications received for conduct of Global Clinical Trials (i.e. Form 44), review, approval and follow-up until end of study as per Schedule Y, Rule 122 DA, 122 DAB, 122 DAC and 122 E under Drugs & Cosmetics Rules 1945)

• Review and approval of Test License applications (Form 12) to import the Investigational Medicinal Products (IMP) for Global Clinical Trials.

• Review of notification for Non-interventional/Observational/Academic/Investigator Initiated Trials.

• Review and approval of post approval changes applications like Major protocol amendments &change in sponsors/applicant etc.

• Review of notifications like Minor protocol amendments, Investigator’s Brochure (IB), Informed Consent Form (ICD), Investigational Medicinal Product Dossier (IMPD), Development Safety Update Reports (DSUR), site additions/deletions, Change in Principal investigators/Co-investigators, Clinical Trial Agreements, Ethics committee approval of PI sites, Annual Status Reports, End of clinical trial notifications& Clinical Study Reports (CSR) etc.

• Handling of complaints, parliament questions and RTI queries related to Global clinical trials.

• Handling/Monitoring of GCP Inspections based on the trial monitoring documents like PSURs, ASRs, complaints received etc.

• Review & action taken in respect to GCP inspection reports received from Inspection Team/Zonal Offices (Show-cause notice, response of show-cause notice, warning, debarment, suspension etc.)

• Data-base management (receipts/files/other misc. data including permissions generated, maintenance of guard files of query/approvals, parliament questions answered, CSR etc.)

GCT Processes  

•     Guidelines Document
• Guidance on Clinical Trial Inspection
•     Sugam User Manual
•     FAQ
•     Checklist Documents