INFORMED CONSENT PROCESS – ETHICS AND COMPLIANCE - Qtech-Sol USA offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Clinical Research
 
Duration:
3 Weeks / 80 Hours
 
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ICET: Informed Consent Process – Ethics and Compliance

Introduction – Informed Consent in Clinical Research

The informed consent process (ICP) is the cornerstone of ethical clinical research, ensuring that trial participants fully understand the study, its risks, benefits, and their rights before agreeing to participate. Regulatory bodies such as the FDA, EMA, and ICH-GCP mandate strict standards to protect participants’ safety, rights, and well-being.

The ICET program provides learners with an in-depth understanding of the ethical, regulatory, and operational aspects of informed consent. It covers requirements for documentation, communication, and compliance, ensuring perpetual readiness for audits and inspections.

Course Name :  Informed Consent Process – Ethics and Compliance
Course Code :  ICET
Experience Level :  Entry to Intermediate
Qualification :  Bachelor’s / Master’s in Life Sciences, Nursing, Pharmacy, Public Health, Regulatory Affairs, or related fields
Student Category :  Clinical Research Coordinators, Clinical Data Managers, CRAs, CTAs, Regulatory and QA Professionals

Delivery Type

SIP – Self-Paced Online with Support

Duration & Delivery
  1. Course Duration: 3 weeks (80 hours)
  2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).
Key Learning Objectives

   By completing this program, learners will:

  1. Understand the ethical principles of informed consent in clinical research.
  2. Learn the ICH-GCP, FDA, and EMA requirements for consent processes.
  3. Explore the essential elements of informed consent forms (ICFs).
  4. Recognize the role of ethics committees/IRBs in reviewing and approving ICFs.
  5. Learn how to communicate study information clearly to participants.
  6. Gain knowledge of re-consent requirements in protocol amendments or safety updates.
  7. Review common inspection findings related to informed consent.
  8. Practice case scenarios to apply ethics and compliance principles.
Who Should Take This Course
  1. Clinical Research Coordinators (CRCs) conducting consent discussions.
  2. Clinical Research Associates (CRAs) monitoring site compliance.
  3. Clinical Data Managers (CDMs) ensuring documentation integrity.
  4. Regulatory and QA professionals preparing for inspections.
  5. Career changers moving into clinical trial compliance roles.
    .
Benefits & Outcomes
  1. Clinical Research Coordinator (CRC)
  2. Clinical Trial Assistant (CTA)
  3. Clinical Research Associate (CRA – Ethics Oversight)
  4. Regulatory Affairs Specialist
  5. QA/Compliance Officer

    .

Career Pathways: After completing this course
  1. Clinical Trial Assistant (CTA)
  2. Clinical Research Coordinator (CRC)
  3. Clinical Research Associate (CRA – entry level)
  4. Clinical Data Coordinator
  5. Clinical Trial Project Support Specialist

Curriculum & Modules

Modules
1. Introduction to Informed Consent & Clinical Research Ethics

2. Regulatory Framework (ICH-GCP, FDA, EMA, HIPAA)

3. Essential Elements of Informed Consent Forms (ICFs)

4. Role of IRBs/ECs in Approving Consent Documents

5. Conducting the Consent Discussion with Participants

6. Documentation & Version Control of ICFs

7. Re-Consent Requirements in Protocol Amendments

8. Special Populations (Minors, Vulnerable Subjects)

9. Common Audit Findings in Informed Consent Compliance

10. Case Studies – Ethics in Action
Getting in Touch:

For more information, please call us at +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email qpdc@qtech-solutions.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.