Duration : 3 Months
Mode : Online/Offline/Hybrid
Course Overview
- A Clinical Research Coordinator (CRC) plays a vital role in the successful execution of clinical trials, ensuring compliance with regulatory guidelines and smooth site operations. This comprehensive training program provides hands-on expertise in study coordination, regulatory requirements, and patient safety management, preparing you for a rewarding career in clinical research.
- 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
Phase of Drug development and role of regulated Clinical research
2
Structure of Healthy volunteer Clinical Trial Setup and Study Flow
3
Structure of patient based Clinical Trial Setup and Study Flow
4
The stakeholders in Clinical trials Roles and responsibilities of Sponsor, Ethics Committee, Investigator/Sites and Regulatory Agency
5
Clinical Trial Study Design
6
Roles and Responsibilities of CRC
7
Essential Documents
Protocol
Informed consent form
Case record form/other forms
Use of study related plans
Trial master file (TMF) Preparation and Maintenance (TMF Management)
8
Preparation of Site for Study feasibility Assessment
Site readiness for Qualification and Initiation
9
Ethics committee/ Regulatory pathway
A. IRB/IEC,
B. Conflict of interest,
C. Confidentiality,
D. vulnerable population,
E. Informed consent procedure
10
Dossier Submission
11
Managing, Handling and Accountability of Investigational products and critical supply chain elements
12
Good Clinical Practice (ICH E6)
13
New Drug Clinical Trial Rule (NDCT)
14
Indian Council of medical research (ICMR) Guideline
A. Data entry, principles of ALCOA+
B. Discrepancy management
C. Data privacy and storage
D. Case Studies
15
Informed consent Procedure & Case Studies
16
Patient/Participant Recruitment, Retention, and Compliance
17
Guidelines for Reporting of AE/SAE
18
Over View of SMV & SCV
19
Handling of Audit & Inspection
20
Site Close Out
21
MCQ Based final Exams
Why Enroll in This Course?
- Gain practical knowledge from industry experts
- Hands-on training in clinical trial coordination
- Learn global and Indian regulatory guidelines
- 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.
Useful Links
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Contact us
- 2nd floor, 17, Sigma Corporates, Sindhubhavan road, Opp. Courtyard Marriott, Bajarang Cross road, Ahmedabad, India, Gujarat