Intro To Clinical Research - Crc

Building a Foundation in Clinical Trials and Human Health Research, Your First Step into the world of Clinical Research

What you'll learn

Define the Fundamental Concepts and Terminology of Clinical Research

Describe the Roles and Responsibilities of Key Stakeholders

Outline the Basic Steps involved in Designing and Conducting a Clinical Trial

Identify the Major Regulatory and Ethical Frameworks

Requirements

No Experience Required. This course is constructed to provide an overall understanding of the Clinical Research Field. Curated both towards beginners who want to learn more and/or Experienced coordinators who would like a refresher.

Description

“Introduction to Clinical Research” is a foundational course designed to demystify the world of clinical trials and offer a clear, accessible entry point into one of the most impactful areas of healthcare and medical science. Whether you're exploring a new career path, preparing to enter the field, or simply curious about how medical treatments are tested and approved, this course will provide the knowledge and clarity you need.Throughout this course, you'll learn:What clinical research is and why it’s essential to public healthHow clinical trials are designed, regulated, and conductedThe ethical and regulatory frameworks that ensure participant safety (GCP, FDA, IRBs)Key roles and responsibilities within research teams (CRC, CRA, PI, etc.)The basics of data collection, documentation, and monitoringReal-world insights into career opportunities and pathways in clinical researchThis course was created with three goals in mind:To raise public awareness about clinical trials as a potential healthcare optionTo educate and empower those exploring or entering the fieldTo highlight a meaningful, yet often overlooked profession in healthcareIf you’re looking for a way to break into clinical research, understand how trials contribute to medical progress, or support others through their research journey — this course is your starting point.

Overview

Section 1: Introduction

Lecture 1 Introduction to Course

Lecture 2 Personal Background

Lecture 3 What is Clinical Research?

Lecture 4 Who is Involved in Clinical Research?

Lecture 5 Where are Clinical Research Processes conducted?

Section 2: Regulatory and Ethical Foundations

Lecture 6 Introduction

Lecture 7 Good Clinical Practice Guideline (GCP)

Lecture 8 FDA Regulations Framework

Lecture 9 Institutional Review Board's/Ethics Committees

Lecture 10 Compliance and Inspection Processes

Section 3: Research Protocols

Lecture 11 Introduction

Lecture 12 Inclusion/Exclusion

Lecture 13 Schedule of Activities (S.O.A)

Lecture 14 Adverse Events/Reporting

Lecture 15 Protocol Deviations

Lecture 16 Prohibited/Restricted Medications

Lecture 17 Data Entry

Section 4: Lab Manual

Lecture 18 Introduction

Lecture 19 Specimen Collection

Lecture 20 Processing/Handling

Lecture 21 Shipping

Lecture 22 Documentation

Section 5: Documentation and Data Management

Lecture 23 Introduction

Lecture 24 Case Report Forms (CRF)

Lecture 25 Regulatory Binders

Section 6: Monitoring and Quality Assurance

Lecture 26 Introduction

Lecture 27 Site Visits

Lecture 28 Source Data Verification (SDV)

Lecture 29 Regulatory Reporting & Audits

Section 7: Career Pathways in Clinical Research

Lecture 30 Introduction

Beginners in the field of Healthcare,People with a general curiosity for Clinical Research/Drug Development,Experienced Healthcare/Clinical Research Professionals who would like a fresher