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Course

CT: Good Clinical Practice (GCP) in Human Clinical Trials

FPM-40204

Topics include the definition and identification of good clinical practices (GCPs); how GCPs affect the conduct of clinical trials; regulating agencies and applicable regulations from the Code of Federal Regulations and ICH guidelines; state regulations; obligations of investigators, sponsors, monitors, and IRBs; compliance and accountability during clinical trials; protocol violations and deviations; consequence of falsification of data and/or patient records; and the blacklist. Device regulations also covered.

Course Information

Online
3.00 units
$645.00
Notes: No textbook required. Requirement for Professional Certificate in Clinical Trials Design and Management.

Course sessions

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Section ID:

194303

Class type:

Online Asynchronous.

This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.

Textbooks:

No textbook required.

Policies:

  • No refunds after: 1/12/2026

Schedule:

No information available at this time.
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Instructor: Gustavo Poveda

Gustavo Poveda
Gustavo A. Poveda, B.Sc. is a clinical research and drug development professional with 20+ years of experience leading U.S. and global teams in the planning, execution, and delivery of phase I-IV human clinical trials across multiple therapeutic indications. His overall experience has been forged over 30 years by working in academic medical research and in advancing roles (field monitoring, project management, strategic alliance/program oversight, and tactical advising) within/with global CROs and alongside large pharmaceutical and small biopharma companies.
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