Review of Documents

- To review & comment on the draft protocol, draft Informed Consent Documents (English ICD), draft Case Report Form (CRF) and/or associated documents received from (Medical Writer team) as per SOP and applicable regulatory guidelines.
- To review & comment on draft report including all appendices (Clinic related sections) and final e-CTD report received from Report writer in accordance with related SOP/regulatory guidelines/sponsor requirement.
- To review the respective documents as per defined timelines and/or as per the priority.
- To review the respective documents updated based on sponsor comment, regulatory observation and ensure compliance to the same.

Review SOPs and System Compliance

- To responsible to review departmental SOPs.
- To review Sponsor comments and regulatory observations and provide response within stipulated timeline.
- Co-ordinate with team for implementing current sop in the system.
- Ensure that necessary corrective actions are taken for all the findings/comments/suggestions with appropriate preventive measures.
- Any other task assigned by reporting authority.

📌 Quality Control (Ahmedabad)
🏢 Veeda CR
📍 Ahmedabad