Diploma in Clinical Research & Data Management
The Advanced Diploma in Clinical Research & Data Management (ADCR-DM) is designed to provide students a complete understanding of clinical research and clinical data management processes. It equips you to start a career in Clinical Research Operations or as a Clinical Data Management professional. The course is aligned to the requirements of the industry and includes hands-on training modules on Oracle Siebel Clinical – CTMS for Clinical Research and Oracle Clinical – CDMS for Clinical Data Management.
- 24×7 access to the Oracle Siebel Clinical & Oracle Clinical software.
- Full access to e-Learning Portal containing Multimedia Tutorials and Quizzes.
- Course Instructor support via Discussion Forums
- Module 1 – General Introduction
- Module 2 – Epidemiology and Evidence Based Medicine
- Module 3 – Pharmaceutical Medicine
- Module 4 – Therapeutic Areas
- Module 5 – Ethics in Clinical Research
- Module 6 – Roles and Responsibilities
- Module 7 – Clinical Trial Preparation
- Module 8 – Essential Documents and Regulatory Submission
- Module 9 – Study Start-up
- Module 10 – Clinical Trial Monitoring
- Module 11 – Compliance and Audits
- Module 12 – Data Management and Biostatistics
- Module 13 – Regulatory Affairs in Clinical Research
- Module 14 – Medical Device Trials
- Module 15 – Project and Vendor Management
- Module 16 – Financial Management of Clinical Trials
- Module 17 – Personality Development and Communication Skills
- Module 18 – Oracle Siebel Clinical CTMS
- Module 19 – Basics of Clinical Data Management
- Module 20 – Clinical Data Management Processes and Standards
- Module 21 – Clinical Data Management Systems
- Module 22 – Oracle Clinical Fundamentals
- Course Completion
At the end of the course, students will be awarded a certificate of completion.
Duration: 6 months