Skip to content
Clinical Research Made Simple

Clinical Research Made Simple

Trusted Resource for Clinical Trials, Protocols & Progress

Tag: eConsent clinical trials

Informed Consent Process in Clinical Trials: A Step-by-Step Guide to Ethical Participant Engagement

Posted on May 14, 2025 digi By digi

Informed Consent Process in Clinical Trials: A Step-by-Step Guide to Ethical Participant Engagement Mastering the Informed Consent Process: Ethical Participant Engagement in Clinical Trials The informed consent process is fundamental to ethical clinical research. It empowers potential participants with the knowledge necessary to make voluntary, informed decisions about joining a clinical study. A robust, participant-centered…

Read More “Informed Consent Process in Clinical Trials: A Step-by-Step Guide to Ethical Participant Engagement” »

Informed Consent and Ethics Committees, Informed Consent Process

Quick Guide

  • Clinical Trial Phases
    • Preclinical Studies
    • Phase 0 (Microdosing Studies)
    • Phase 1 (Safety and Dosage)
    • Phase 2 (Efficacy and Side Effects)
    • Phase 3 (Confirmation and Monitoring)
    • Phase 4 (Post-Marketing Surveillance)
  • Regulatory Guidelines
  • Clinical Trial Design and Protocol Development
  • Good Clinical Practice (GCP) and Compliance
  • U.S. FDA Regulations

Menu

Recent Posts

  • Statistical Simulation Models in Dose Optimization
  • Pharmacogenomics in Phase 4 Clinical Trials: Identifying Risk Populations Through Genetic Insights
  • Post-Hoc Analyses and Subgroup Evaluation in Phase 3 Clinical Trials: Purpose, Pitfalls, and Strategic Applications
  • Use of Phase 1 Data in NDA/BLA Submissions: What Regulators Look For
  • Go/No-Go Decision Criteria for Advancing to Phase 3

Copyright © 2025 Clinical Research Made Simple.

Powered by PressBook WordPress theme