PG Diploma in Clinical Trial Management

Duration of course

• 12 months

Course Curriculum

• Drug Development Process, Clinical Trial terminology (New Drug Discovery)
• Various Stages in Clinical Drug development (Phase I to IV)
• Clinical Trial Budgeting
• Principles of good clinical practices
• Ethics in Clinical Research
• Roles and responsibilities of IRB/IEC
• Informed Consent Process
• Roles and responsibilities of :
  i. Sponsor
  ii. Investigator
  iii. Research Coordinator
  iv. Contract Research Organization
  v. Clinical Data Manager
• Clinical Trial Documents
• Regulatory requirements in India, Japan, USA, Europe
• Quality Assurance and Patent Laws
• Audits & Inspection in Clinical Research
• Conducting BA/BE Studies
• Patient recruitment and retention in Clinical Trials
• Preparation of Protocol, CRF and trial related documents
• Clinical Trial Designing
• Management of Clinical Trials
• Biostatistics in Clinical Research
• Medical Writing

Course timings

4 hours on every Saturday/Sunday of the month.