Diploma in Clinical Research & Pharmacovigilance
The Advanced Diploma in Clinical Research & Pharmacovigilance (ADCR-PV) covers the core areas of the Clinical research and Pharmacovigilance processes and equips you to start a career as a Clinical Research or Drug Safety professional. The course is aligned to the requirements of the industry and imparts clinical research and pharmacovigilance process knowledge in a clear and concise manner so that you may kickstart a career in clinical research and pharmacovigilance. This program includes hands-on training modules on Oracle Siebel Clinical – CTMS for Clinical Research and Oracle Argus Safety for Pharmacovigilance.
- 24×7 access to the Oracle Siebel Clinical & Oracle Argus Safety 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 – Principles of Pharmacovigilance
- Module 20 – Pharmacovigilance and Selected System Organ Classes
- Module 21 – Pharmacovigilance Systems
- Module 22 – Global Pharmacovigilance and Safety Standards
- Module 23 – Pharmacovigilance Regulations and Guidelines
- Module 24 – Pharmacoepidemiology
- Module 25 – Oracle Argus Safety Essentials
- Course Completion
At the end of the course, students will be awarded a certificate of completion.
Duration: 6 months