Duration : 2 Weeks
Mode : Online/Offline/Hybrid
Course Overview
- Good Clinical Practice (GCP) is the foundation of ethical, safe, and high-quality clinical research. This comprehensive training program equips you with in-depth knowledge of GCP guidelines, regulatory compliance, and industry best practices, ensuring that clinical trials are conducted with integrity and efficiency. It is designed to include the Point of view of all stakeholders in a regulated clinical trial
- Sponsor
- Investigator / Sites
- Ethics Committee
- Regulatory bodies
- It is designed to include the Point of view of all stakeholders in a regulated clinical trial
- Sponsor
- Investigator / Sites
- Ethics Committee
- Ethics Committee
- The modules are dynamically designed to include all critical formats of a GCP compliant Clinical Trial
- Learning is multimodal and emphasized through Hands on activities, group exercises, electronically integrated activities, competitive quizzes, open discussions/debates, role play, and activities, audio visual aids. The reliance on one way lecture format through power points slides is lean and situational.
- The training workshop will be a multimodal format – Class room sessions, group activities, PPT, Learning &Training software, Quizzes and Interaction/Session with Industry Expert.
- The training workshop will be a multimodal format – Class room sessions, group activities, PPT, Learning &Training software, Quizzes, site visits and Interaction/Session with Industry Expert.
- Our training program features engaging and interactive content meticulously crafted by skilled content writers and industry experts. The comprehensive curriculum includes audio-visual elements, interactive quizzes, illustrative examples, images, and in-depth case studies. Designed to enhance learning and retention, this innovative approach ensures a dynamic and enriching training experience. Training execution and tracking of participants' progress take place through professional, validated eLearning software.
- Post training, Final assessment / Exam for each participant will be done before concluding the training as successful
Crash Course
Sr
Topic
1
Phase of Drug development and role of regulated Clinical research
2
Healthy volunteer Clinical Trial Setup and Study Flow
3
Basics of Clinical Trial Setup and Study Flow
4
The stakeholders in Clinical Research Roles and responsibilities of Sponsor, Ethics Committee, Investigator/Sites and Regulatory Agency
5
Ethics committee
A. IRB/IEC,
B. Conflict of interest,
C. Confidentiality,
D. vulnerable population,
E. Informed consent procedure
6
Managing, Handling and Accountability of Investigational products and critical supply chain elements
7
Good Documentation Practices
A. Data entry, principles of ALCOA+
B. Discrepancy management
C. Data privacy and storage
D. Case Studies
8
Good Clinical Practice (ICH E6)
9
Trial Master File & Category of Essential Record
10
Guidelines for Reporting of AE/SAE
11
MCQ based Final Exam
Why Enroll in This Course?
- Learn from industry experts with real-world experience
- Comprehensive training aligned with global regulatory standards
- Hands-on case studies and interactive learning
- Enhance your career prospects in clinical research
Cliantha Academy, an affiliate of Cliantha Research, offers offline clinical research courses that are widely recognized in the clinical research industry, enhancing both your employment opportunities and the outcomes of trials.
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Contact us
- 2nd floor, 17, Sigma Corporates, Sindhubhavan road, Opp. Courtyard Marriott, Bajarang Cross road, Ahmedabad, India, Gujarat