Course Duration:

• 30+ modules and 40+ hours with flexible online and offline sessions.

Modules

1. Organization Structure in Clinical Research
   Learn about the hierarchical structure within clinical research organizations and the roles of various departments.
2. Role of Contract Research Organization (CRO)
   Understand the critical role CROs play in clinical research, from trial design to regulatory approval.
3. Drug Development and Introduction to Clinical Research
   Explore the drug development process and the basics of clinical research.
4. Good Clinical Practices (GCP)
   Study the international ethical and scientific quality standards for designing, conducting, and reporting trials involving human subjects.
5. Description of Phase I-IV and Role of DCGI
   Gain insights into the different phases of clinical trials and the role of the Drugs Controller General of India (DCGI).
6. Institutional Review Board (IRB) / Ethics Committee
   Learn about the function and importance of IRBs and Ethics Committees in protecting the rights and welfare of clinical trial participants.
7. Informed Consent
   Understand the process and significance of obtaining informed consent from trial participants.
8. Training on Case Report Form (CRF) Writing
   Acquire skills in writing and designing CRFs, crucial for data collection in clinical trials.
9. Clinical Trial Design
   Study the principles and methodologies of designing clinical trials.
10. Protocol as a Clinical Tool
    Learn about the clinical trial protocol, a critical document that outlines the study plan.
11. Evaluation of Clinical Research Site
    Understand the criteria and procedures for evaluating clinical research sites.
12. Clinical Research Documentation
    Gain knowledge of the essential documents required in clinical research.
13. Evaluation and Monitoring of Source Documentation
    Learn the importance of source documents and the procedures for their evaluation and monitoring.
14. Trial Monitoring and Responsibilities
    Understand the roles and responsibilities of trial monitors in ensuring compliance and data integrity.
15. Regulatory Aspects of Clinical Research
    Study the regulatory requirements and guidelines governing clinical research.
16. Quality Assurance and Documentation
    Explore the principles of quality assurance and the importance of proper documentation.
17. Adverse Event and Adverse Drug Reaction
    Learn to identify, report, and manage adverse events and adverse drug reactions in clinical trials.
18. Research Misconduct
    Understand the various forms of research misconduct and the importance of ethical conduct in clinical research.
19. Central Roles of Sponsor and Principal Investigator
    Study the responsibilities and roles of sponsors and principal investigators in clinical trials.
20. Participants Recruitment and Retention
    Learn strategies for recruiting and retaining participants in clinical trials.
21. Medical Writing
    Acquire skills in medical writing, including the preparation of clinical trial reports and regulatory documents.
22. Project Management in Clinical Research
    Understand the principles and practices of project management in the context of clinical research.
23. Practical Training on Statistical Software and Case Study Analysis
    Gain hands-on experience with statistical software and case study analysis in clinical research.
24. Overview of Clinical Data Management
    Learn about the processes and systems involved in managing clinical trial data.
25. Roles and Responsibilities of CRC, CRA, QC, QA
    Understand the roles and responsibilities of Clinical Research Coordinators (CRC), Clinical Research Associates (CRA), Quality Control (QC), and Quality Assurance (QA) professionals.
26. Roles and Responsibilities of Clinical Data Management Personnel
    Study the specific roles and responsibilities of personnel involved in clinical data management.
27. Pharmacovigilance
    Learn about the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
28. Good Documentation Practice Training in Clinical Trials
    Understand the principles of Good Documentation Practices (GDP) in clinical trials.