Certificate Program for Clinical Trial Investigators & Site Personnel
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 increase the understanding of the Clinical Research process. Learn the essential skills, knowledge, competencies and roles & responsibilities of an investigator & site personnel.
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
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
Certificate Program for Clinical Trial Investigators & Site Personnel