Clinical Development 101: General Principles

  • Course Price: $150 USD
  • BIO Member Price: $120 USD
  • Course Run Time: 55 minutes
  • Course Level: Level 1 - Foundational
  • Completion Period: 2 week

Clinical Development 101: General Principles sets the stage for the entire clinical development process. The general principles discussed include who conducts trials and their roles; how clinical trials are designed to reduce bias; why Good Clinical Practices help manage risk. Clinical Development 101 provides the foundational knowledge needed to understand the Clinical Trial Phases I-IV.


Takeaways
  1. Ability to explain the purpose of each clinical trial phase and list its milestone.
  2. Familiarity with individuals and groups conducting a clinical trial and their roles. 
  3. Fluency in drug development concepts such as control groups, bias, blinding, randomization, and endpoints.
  4. Knowledge of the study design criteria to reduce bias and keep patients safe.
  5. Required regulatory studies and the data collected to enable follow-on studies.
Certificate Requirements
  • View the entire course
  • Pass course assessment with a 70 percent
Download Agenda
Certificate Requirements
  • View the entire course
  • Pass course assessment with a 70 percent
Clinical Development 101 Trailer
Section 1: Introduction
Describes the key milestones for drug development, specifically focusing on clinical development. Important terms including evidence-based medicine,...More
Section 2: Clinical Trials - Basic Principles
Explains how risk management is approached in terms of scientific method, Good Clinical Practices (GCPs), and trial design. Bias, blinding, randomizat...More
Section 3: Conducting Clinical Trials
Explains the various clinical trial participants and their roles, identifies the basic elements of a clinical protocol, describes informed consent, di...More
Final Quiz
LinkedIn Certificate Demo
Certificate Requirements
  • View the entire course
  • Pass course assessment with a 70 percent