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Clinical Development 101:  General Principles

Clinical Development 101: General Principles sets the stage for the entire Biotech Primer clinical development series by covering the essential terms, milestones, and considerations needed to understand the clinical development process. This Primer dives into the core principles of current Good Clinical Practices and how to manage risk for study volunteers. Clinical Development 101 focuses on the most relevant study designs, inclusion/exclusion criteria for selecting participants, and ethical considerations that must be met. The class ends by establishing master data management and reporting standards required for regulatory filings. Register now for Clinical Development 101: General Principles and establish a baseline understanding of clinical trials.

Section 1: Clinical Development Introduction

Describes the key milestones for drug development, specifically focusing on clinical development. Important terms including evidence-based medicine, translational medicine, and patient-centric clinical trials are explained. Finally, the purposes for which clinical trials are conducted are explored.

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, randomization and endpoints are all explained in detail.

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, discusses inclusion/exclusion criteria, lists the steps in data management and reporting, and reviews the concept of clinical trial transparency.

Five Takeaways

 

  1. Enumerate the clinical trial phases in order, explain the purpose of each, and list their milestones.
  2. Identify the key individuals and groups involved in clinical trials and explain their roles in detail.
  3. Define foundational drug development concepts to control bias, such as control groups, blinding, and randomization.
  4. Choose the appropriate study design criteria to reduce bias and ensure patient safety.
  5. Compile a list of regulatory studies and the data each collects to enable follow-on studies.

Features

  • Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Course materials
  • Real-time tracking
  • Progress reporting
  • Accessibility features
  • Corporate account upgrades
  • LinkedIn certificate attachment
  • Verified certificates

FAQ

  • How long do I have to complete an on-demand course?  You have one year from the date of purchase to complete the course. During that year, you may watch the class an unlimited number of times.
  • What happens if I don’t complete the course in one year?  There are no time extensions. If you want to complete the course, you must purchase it again.
  • How long are the on-demand classes?  Our longest course has a running time of 90 minutes. However, most have a running time of 45 minutes.  The running time is listed for each class on its registration page. The assessment at the end of each course takes between 10-20 minutes to complete.
  • Are there any downloadable class materials? No. All course slides and transcripts remain on your Biotech Primer dashboard, but they are always available for review.
  • What is the format of the on-demand classes?  The online class begins with the class objectives and the course itself and ends with a summary of what you learned. The course is a series of images and text accompanied by a professional voice-over and subtitles. Subtitles are available in 9 languages. The course ends with a quiz to assess your understanding.
  • Can I repeat the course?  You can repeat the course as often as you like within your one-year access.
  • How many times can I take the course quiz?  You have three chances to pass the quiz. A passing score is 75% or higher. You must pass the quiz to receive the class certificate. Your quiz score will be shown on your class certificate.
  • May I share a course I purchased with others?  Each course is to be taken by one individual. If you want to learn as a group, please contact us at training@biotechprimer.com for group pricing.

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