Duration : 2 Weeks
Mode : Online/Offline/Hybrid
Course Overview
- Clinical trial monitoring plays a critical role in ensuring data integrity, participant safety, and regulatory compliance. This specialized training equips you with in-depth knowledge and hands-on expertise in various monitoring strategies, site visits, and risk-based approaches.
- The entire training module is structured as per the flow of a Randomized Clinical Trial and includes discussion on activities, documents, personnel required during
- Planning & Setup.
- Study execution.
- Study close out, analysis, reporting
- 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.
- All critical aspects such as Site initiation, ICF, AE/SAE reporting, Essential documents, TMF etc will be through filling and filing of dummy documents and simulation exercises.
- 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
Course Content
Sr
Topic
1
Patient based Clinical Trial Setup and Study Flow
2
The stakeholders in Clinical trials Roles and responsibilities of Sponsor, Ethics Committee, Investigator/Sites and Regulatory Agency
3
Essential Documents
Protocol
Informed consent form
Case record form/other forms
Use of study related plans
4
Study feasibility Assessment
Site Qualification & Site selection and initiation
5
Site Monitoring plan
6
Site Monitoring Visit - Study oversight and compliance & managing deviations
7
Site Monitoring Report
8
Study closure/Site Close Out
9
Centralized Monitoring
10
Risk Based Monitoring
11
Decentralized Clinical Trial
12
MCQ based final Exam
Why Choose This Course?
- Learn from industry experts
- Hands-on training with real-world case studies
- Gain expertise in regulatory compliance & site monitoring
- Career-enhancing certification in clinical trial monitoring
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