Informed Consent Process - PharmD Guru

Overview

• Published Date: October 31, 2021
• Category: Clinical Research
• Relevance: Part of PharmD Fifth Year Notes

Informed Consent Process

• Essential part of clinical research.
• Involves informing research participants about the study they are part of.

Key Components

• Purpose of Study: Explain why the research is being conducted.
• Procedures and Protocols: Outline what will happen during the study, including any interventions or observations.
• Risks and Benefits: Clearly communicate any potential risks, side effects, or benefits of participating.
• Voluntary Participation: Participants must know that participation is voluntary and they can withdraw at any time without penalty.
• Confidentiality: Assure participants that their data will be kept confidential.

Related Topics

• Designing Clinical Study Documents: Protocol, Case Report Form (CRF), and Informed Consent Form (ICF).
• Drug Development Process: Overview of steps in developing new drugs.
• Introduction to Clinical Trials: Basics of how clinical trials are conducted.

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