Program Overview
This one-day, workshop-based training program is designed to provide a strong foundation in clinical research principles and Good Clinical Practice (GCP) guidelines, with a practical, application-oriented approach. The program is ideal for professionals seeking structured exposure to the clinical research and drug development ecosystem, complemented by interactive learning and essential soft-skill development.
A comprehensive, instructor-led workshop focused on:
- Core concepts of clinical research and drug development
- Practical understanding of GCP guidelines and ethical conduct of clinical trials
- Regulatory expectations and real-world trial execution
A comprehensive, instructor-led workshop focused on:
- One-day intensive, hands-on workshop format
- Expert-led live lectures and interactive discussions
- Practical insights aligned with industry and regulatory expectations
Why choose this Course?
Self-Paced Learning
Flexible format that fits around professional or academic schedules.
24/7 Expert Academic Support
24/7 faculty guidance for queries, feedback, and learning clarity.
Industry-Ready Content
Curriculum mapped to current industry practices and GCP standards.
A Standout Portfolio
Assignments that showcase trial design and operational know-how.
Real-World Projects & Case Studies
Applied real-world case studies reflecting actual scenarios.
Placement Assistance
Career guidance and interview readiness for industry roles.
Course Details
Module 1: Introduction to Clinical Research
Duration: Self-Paced
Topic Covered
Training on topics such as principles of clinical research
Drug discovery
Clinical Trial Process
Phases of Clinical Trials
Regulatory Framework
Study Designs
Module 2: Principles of Good Clinical Practices (GCP)
Duration: Self-Paced
Topic Covered
Training on principles of GCP
Applicable GCP guidelines
The evolution of GCP guidelines
Responsibilities of various stakeholders (Sponsor, CRO, Investigator, and Ethics Committee).
Module 3: Essential Clinical Trial Documents
Duration: Self-Paced
Topic Covered
Training on topics such as protocol
Informed consent document (ICD)
Investigator’s brochure (IB)
Case report form (CRF)
Source data/document (SD)
Regulatory and ethics approval
Clinical trial agreement (CTA)
Clinical trial liability insurance
Clinical study report (CSR)
Module 4: Ethical Review
Duration: Self-Paced
Topic Covered
Training on topics such as categories of review
Review documents
Quorum requirements
Notification of meeting and distribution of material
Meeting procedure
Module 5: • Informed Consent Process
Duration: Self-Paced
Topic Covered
Training on topics such as essential elements of patient information sheet and informed consent form
Regulatory requirements
Informed consent process
Module 6: Safety Reporting and Compensation
Duration: Self-Paced
Topic Covered
Training on topics such as adverse events
Serious adverse events
Reporting timelines
Compensation in case of clinical trial injury/death
Compensation formula Evaluation in Oncology Clinical Trials (WHO, SWOG, RECIST)
Module 7: Regulatory Landscape
Duration: Self-Paced
Topic Covered
Training on topics such as recent regulatory changes
Policy initiatives (New Drugs and Clinical Trials Rules, 2019).
Course Schedule
1
Receive Study Material
Upon registration, you will receive four comprehensive Learning Modules along with an Assignment Workbook.
2
Study & Complete Assignments
Go through the modules and complete the assignments within the standard 4.5-month duration.
3
Option for Early Completion
If you wish to finish sooner, you may submit your completed workbook with an early assessment request.
4
Assessment
Your Assignment workbook is evaluated based on the qualification criteria.
5
Earn Your Certificate
After successful assessment, you will be awarded a Certificate of Completion.
Registration Process
Three-step registration process:
1
Get the Registration Link/QR
Receive the registration link and QR code from us.
2
Complete the Form & Payment
Fill out the registration form and pay the course fee using the QR code.
3
Receive Confirmation
Get an acknowledgement call confirming your successful registration.
Program Fee
Indian Participants
₹14000
Foreign Participants
$350
This course includes
Duration
Self-Paced
Lessons
7
Students
5000+
Language
English, Hindi
Certificate
Yes
Contact for more details of the course
Student Testimonials
This course transformed my career! The hands-on projects and expert guidance helped me land my dream job as a React developer.
JD
- John Doe
I highly recommend this course to anyone looking to master React. The curriculum is well-structured, and the instructors are knowledgeable and supportive.
JS
- Jane Smith
The practical approach of this course made learning React enjoyable and effective. The projects were challenging yet rewarding, and I gained real-world skills.
MJ
- Mike Johnson
As a beginner, I was initially intimidated by React, but this course broke down complex concepts into easy-to-understand lessons. The community support was also fantastic!
ED
- Emily Davis
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