Certificate Program for Monitoring of Clinical Trials

Certificate

Distance

₹ 15,000 + VAT

Description

  • Type

    Certificate

  • Methodology

    Distance learning

  • Location

    Bhopal

  • Duration

    6 Months

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

Facilities

Location

Start date

Bhopal (Delhi)
See map
Medical Director Cliniminds Unit of Tenet Health Edutech Pvt. Ltd. C-55, 1st Floor, Preet Vihar, Main Vikas Marg, 110092

Start date

On request

About this course

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.

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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

Certificate Program for Monitoring of Clinical Trials

₹ 15,000 + VAT