About the Course

Target Audience

Individuals with or without prior training and experience in clinical research; High School diploma minimum education requirement

Comprehensive Content

Embark on a transformative journey to become a Clinical Research Professional with our comprehensive course. Dive deep into the world of clinical research and equip yourself with the necessary skills to excel in this dynamic field.

Active Learning

Our expert-led curriculum is designed to provide you with practical knowledge and hands-on experience, ensuring you are well-prepared for a successful career in clinical research.

The syllabus

4 Chapters · 6 Lessons

  1. 1

    Principles of ICH GCP R3

    1. (Included in full purchase)

      Scientific Integrity

  2. 2

    ICH GCP R3 Annex I

    1. (Included in full purchase)

      Investigators

    2. (Included in full purchase)

      Sponsors

  3. 3

    ICH GCP R3: Data Governance

    1. (Included in full purchase)

      Safeguarding the Blind

  4. 4

    Appendices

    1. (Included in full purchase)

      Essential Trial Records

    2. (Included in full purchase)

      Clinical Trial Protocol and Protocol Amendments

About the Creator

Dr. Alia Legaux is a former U.S. FDA Investigator with more than 24 years of experience monitoring, inspecting and/or auditing of FDA regulated entities, such as Clinical Research Investigator Sites, Clinical Research Organizations (“CROs”), Sponsors, Ethics Committees, Vendors (i.e. safety reporting, laboratory testing, data management, biostatistics, programming, electronic data capture, interactive voice response services, electronic clinical outcome assessments, central reading and imaging), Compounding Pharmacies, Blood Banks, and/or Tissue Banks.   As an Independent Consultant, Alia provides expertise in quality assurance and compliance. She conducts domestic and international routine, directed (for-cause), qualification, re-qualification, and inspection readiness audits, as well as mock inspections of investigator sites, CROs, Sponsors, vendors, compounding pharmacies, drug manufacturers, packagers, or labelers to assess compliance with applicable regulations, protocols, investigational plans, Standards Operating Procedures (“SOPs”), International Conference on Harmonization (“ICH”) Good Clinical Practice (“GCP”), Good Manufacturing Practice (“GMP”), Good Laboratory Practice (“GLP”), Good Clinical Laboratory Practice (“GcLP”), and Good Pharmacovigilance Practice (“GVP”).   Alia shares her knowledge in the varied training courses offered by CRSC.

Ready to Elevate Your Clinical Trial Skills?

Enroll now and gain access to a wealth of knowledge and practical insights to excel in the world of GCP.

$219.00

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