Steps After IEC Approval

1. Regulatory Authority Approval (if not already obtained)

• Submit/confirm approval from the relevant national regulatory authority (e.g., CDSCO in India, FDA in the US, EMA in Europe).
• In many jurisdictions, IEC approval and regulatory approval run in parallel; both must be in hand before trial initiation.

2. Site Initiation Visit (SIV)

• The sponsor or CRO conducts a Site Initiation Visit to:
  • Train the site staff on the protocol, GCP, and study procedures
  • Verify site readiness (equipment, facilities, staff qualifications)
  • Confirm all essential documents are in the Trial Master File (TMF)

3. Essential Documents Finalization

• Finalize and file all required documents:
  • Signed IEC approval letter
  • Approved Informed Consent Form (ICF)
  • Investigator's CVs and delegation log
  • Protocol and amendments
  • Investigator's Brochure (IB)

4. Investigator Agreement / Contract Execution

• Sign the Clinical Trial Agreement (CTA) between sponsor and investigator/institution (if not done earlier).

5. Drug / Investigational Product (IP) Shipment

• IP is shipped to the site only after regulatory + IEC approvals are confirmed.
• Site receives, logs, and stores IP per protocol requirements.

6. Informed Consent Process

• Site begins screening and enrolling participants, starting with obtaining written informed consent from each subject.

7. First Patient First Visit (FPFV)

• The trial officially begins — first subject is enrolled and dosed.

8. Ongoing IEC Reporting

• Submit progress/status reports to the IEC as required (typically annually or per protocol).
• Report any Serious Adverse Events (SAEs) or protocol deviations to the IEC promptly.
• Submit any protocol amendments for IEC review and re-approval before implementation.