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Phase 1
( Foundational Knowledge)
(15-20) hours 

  1. Pre-course Clinical Research Knowledge Assessment (CRKA)

  2. Introduction to Clinical Trials: This course details how medical products are developed, how volunteer patients are protected, and who plays key roles in the development, research, review and approval of medical products. 

  3. Ethics and Human Subject Protection: A Comprehensive Introduction: This course provides in-depth training on the history and importance of ethical conduct in clinical trials involving human subjects.

  4. Bioethics and Human Embryos: Insights from the Islamic Tradition : 90 mins recorded lecture Aug 2023

  5. Good Clinical Practice (GCP) Simulation: This is an interactive simulation-powered training program that helps ensure compliance with ICH E6 Guidelines. 

  6. The Drug Development Process: ICH E8(R1) – General Considerations for Clinical Trials: This course is an overview of the ICH E8 Guideline and provides awareness of the drug development process. 

  7. Understanding Clinical Trial Protocols: Key Considerations for Effective Development and Feasibility Review: This course incorporates a high-level overview of concepts and real-world scenarios encountered when developing a clinical trial protocol. 

  8. Investigator Responsibilities: This course focuses on the guidelines relevant to the conduct of clinical trials and the responsibilities of the Investigator and clinical research team.

  9. Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety: This course guides you through the complete event reporting cycle and critical timelines as defined in ICH E2a and ICH E6. 

  10. Clinical Trial Monitoring Basics: This course examines various monitoring types and approaches, including site invitations visits, routine monitoring visit, and risk-based monitoring. 

Researcher Looking into Microscope
Happy Scientist

Phase 2
( Intermediate Knowledge )
Advanced Clinical Research Planning & Execution
(10-15) hourus 

  1. Statistical Principles for Clinical Trials: Overview of ICH E9: This course focuses on the ICH E9 Guideline of Statistical Principles for Clinical Trials. 

  2. Informed Consent Simulation: This is an interactive course that helps ensure informed consent is obtained by the right subject, with the right forms by the right person at the right time with the right documentation. 

  3. Implementing a Patient-Centered Informed Consent Process: This course reviews how to assess a participant’s reading level, health literacy, and overall understanding of clinical trial participation and addressing culture, learning styles, emotional states and language. 

  4. Inspection Readiness: Best Practices for Managing Clinical Trial Inspections: This course focuses on GCP inspections by the US Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) but the fundamentals can be applied to any regulatory authority inspection.

  5. FDA Form 1572: Getting it Right the First Time: This course helps to understand how to populate the FDA Form 1572. 

  6. Introduction to Decentralized Clinical Trials (DCTs): This course introduces the concept of DCTs before exploring common DCT approaches, the advantages and challenges of DCT implementation, and tools and considerations for implementing decentralized components in clinical trials. 

  7. Improving Recruitment, Accrual and Retention in Clinical Trials: This course provides best practices to help your clinical research site assess how to better communicate with potential participants and begin a critical reflection of you own skills and organizational practices to improve recruitment and retention with a focus on operational efficiency, cultural competency, and patient centricity

 

Phase 3
( Coming Soon )
 

From new clinical research professionals just starting out to industry veterans looking for ways to move ahead in their careers, ACRP is where success starts — and grows

Our Mission Is to Empower

+200 

Online asset & Module

Complimentary

Access to live webinars of ACRP

Access  

Access

To ACRP Community and Members-Only Discussion Groups

To Local Chapters

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