Certificate Course in Clinical Research (CCCR)
A Clinical Research Course-ICH-GCP E6(R2), Clinical Trials, Essential Documents, Sponsor, Investigator, Pharmaceuticals
4.37 (445 reviews)
2,042
students
3 hours
content
Mar 2025
last update
$64.99
regular price
What you will learn
Basic understanding of Clinical Research
Historical background of US Drug Law and Regulations
Drug approval process in USA, New drug development-Preclinical Steps, IND, NDA, ANDA
Essential Documents in Clinical Research
Protocol
Source Documents
Informed Consent Form (IC Form)
Investigator's Brochure (IB)
Patient Information Sheet
Case Report Form (CRF)
Inclusion-Exclusion Criteria
Information related to Sponsor, Investigator, Clinical Research Coordinator (CRC), Clinical Research Associate (CRA)
Discover how to navigate important websites including ICH Guidelines to find more relevant information.
Professional reputation building and career success enhancement through proper understanding of Clinical Research and related concepts and many more...
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4583968
udemy ID
3/7/2022
course created date
3/17/2022
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