Certificate Program for Monitoring of Clinical Trials
Certificate
Online
Description
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Type
Certificate
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Methodology
Online
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Location
Bhopal
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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
Start date
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.
Reviews
Course programme
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