The monitor oversees clinical trials on behalf of the sponsor to ensure trials are conducted according to regulations. The monitor's responsibilities include ensuring informed consent is obtained properly, investigational products are stored and distributed correctly, only eligible subjects are enrolled, accurate source documents are maintained, and case report forms are complete. The monitor submits written reports to the sponsor summarizing site visits, findings, and any issues requiring action.

1. ROLES AND RESPONSIBILITIES OF MONITOR By: Lekshmi.L.Nair

2. Define Monitor The Monitor is the Individual representing the sponsor who oversees the progress of clinical trial and ensuring that it is conducted, recorded and reported in accordance with protocol, ICH, SOP and other applicable regulatory requirements. Monitor should be Appropriately trained on study procedures Trained/Prior experience in Monitoring Have scientific/Clinical Knowledge Thoroughly familiar with IP, ICF,SOP,SIS,Protocol,GCP

3. Responsibilities of Monitor 1.Compliance to Approved Protocol GCP and other applicable regulatory requirements 2 . Informed Consent Explained properly and correct version used Obtained before any study procedures Documented correctly 3. Investigational Product Storage conditions are acceptable IP’s supplied only to enrolled subjects Given at protocol specified dose Maintain IP accountability Documentation of receipt, use and return of the IP’s at the sites.

4. 4. Ensure Investigators provided with Current IB Study documents 5. Verify Only eligible subjects are enrolled Trial performed by authorized personnel All source documents are accurate, complete, legible, timely, dated and identify the trial. Errors are corrected with sign and date. 6. Case Report Form Accurate and complete Data consistent with the source documents Dose modifications are documented

5. Monitoring Report Submit a written report to sponsor Reports should include Date Protocol Number Site-Number Name of the Investigator Summary forms Procedures reviewed Monitor’s observation and findings Any Outstanding issue Conclusions Actions taken or action recommended to secure compliance

6. Thank you