Certificate Program for Clinical Trial Investigators & Site Personnel


Rs 15,000
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Important information

  • Certificate
  • Online
  • Bhopal
  • Duration:
    6 Months

Course Objectives. To increase the understanding of the Clinical Research process. Learn the essential skills, knowledge, competencies and roles & responsibilities of an investigator & site personnel.

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
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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

This program consists of modules on topics related to Good Clinical Practice (GCP),
applicable to clinical research. This course is intended to provide the necessary training for
investigators and other senior site personnel, to better understand the regulations regarding clinical
research in human subjects, and a better understanding of roles and responsibilities in planning
and conducting clinical trials. The program also covers the regulatory aspects as well. Key topics
covered in the program are:
 Introduction to Clinical Research & Phases of Clinical Trials
 Introduction to ICH GCP / Schedule Y
 Ethical Considerations in Clinical Research
 Investigator Roles & Responsibilities
 "Informed Consent Process & Documentation"
 Safety Reporting
 Study Drug Accountability
 Site Selection Process and Pre-Study Visits
 Routine Site Monitoring Visits
 Site Audits
 Site Close Out

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