WHAT WILL YOU LEARN?

18 CORE AREAS OF CLINICAL TRIAL OPERATIONS

- Knowledge of Indian and international regulatory guidelines applicable to clinical research.
- Clinical trial processes, including study start-up, conduct, and close-out.
- Informed consent procedures and documentation.
- Source documentation, CRF completion, Source Data Verification, and Trial Master File / Investigator Site File maintenance in accordance with ALCOA+ principles.
- Clinical trial narrative writing, including subject visit narratives, Responsible Adverse Event narratives, and protocol deviation narratives.
- Adverse Event Reporting, Regulatory and Judicial Submissions, Follow-up Activities, and Compensation Claim Process.
- Ethics Committee submissions, documentation preparation, correspondence, and follow-up.
- Protocol deviation identification, documentation, reporting, and follow-up.
- Audit and inspection readiness, including document preparation, query responses, and ongoing compliance maintenance.
- Monitoring visit coordination, query resolution, and action item tracking.
- Corrective and Preventive Action preparation, implementation, effectiveness assessment, and follow-up.




- Practical use of Trial Management Systems.
- External certification and learning support.
- Use of AI tools relevant to clinical trial operations, documentation, and workflow support.
- Central laboratory sample processing, handling, and shipment in accordance with the study protocol and laboratory manual.
- Basics of clinical trial agreement execution and documentation, including Clinical Trial Agreements, budget agreements, Confidentiality Disclosure Agreements, and related documents.
- Professional interactions and coordination with investigators, sponsors, Contract Research Organizations, vendors, central laboratories, and other laboratory facilities.
- Opportunities to participate in virtual industry training programmes, workshops, and professional development sessions.

? https://www.kghospital.com/clinical-research

? KG Hospital & Post Graduate Medical Institute & Research Centre, Coimbatore.

Your journey into clinical research starts here!

#ClinicalResearch #ClinicalTrials #ClinicalResearchTraining

📌 Clinical Research Beginners Program (Coimbatore)
🏢 KG Hospital
📍 Coimbatore