Certificate Program for Monitoring of Clinical Trials


Rs 15,000

Important information

  • Certificate
  • Distance learning
  • Bhopal
  • Duration:
    6 Months

Course Objectives. To provide a comprehensive introduction to the clinical research process. To provide comprehensive understanding of the monitoring process.

Important information

Where and when

Starts Location
On request
Medical Director Cliniminds Unit of Tenet Health Edutech Pvt. Ltd. C-55, 1st Floor, Preet Vihar, Main Vikas Marg, 110092, Delhi, India
See map

Frequent Asked Questions

· Requirements

MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharma, Graduate/Post Graduate Degree in Life Sciences, Pharmacology, Pharmacy, Medical Laboratory, Nursing, Biochemistry, Microbiology, Biotechnology and all professionals working with Pharmaceutical companies, CROs and hospitals.

Course programme

The program would cover:
 Introduction to Clinical Research & Phases of Clinical Trials
 Indian Schedule Y & Other Guidelines
 Ethical Considerations in Clinical Trials
 Sponsor/Vendor Responsibilities
 Essential Documents in Clinical Research
 Protocol Writing
 CRF Design
 Site Selection Process
 Pre-study Site Visits Monitoring
 Site Initiation Monitoring
 Routine Monitoring Visit
 Case Report Form Review and Source Document Verification
 Safety Reporting Monitoring
 Study Drug Accountability Monitoring
 Site Close-out Monitoring
 Investigator Responsibilities
 Informed Consent - Process & Documentation
 Investigational Site Audits