Duration : 3 Months
Mode : Online/Offline/Hybrid
Course Overview
- 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
- 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.
- 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
Healthy volunteer Clinical Trial Setup and Study Flow
3
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
Randomization
7
Essential Documents – Pre, During & Post Study
Protocol
Informed consent form
Case record form/other forms
Use of study related plans
Setting of Trial master file (TMF) Preparation and Maintenance (TMF Management)
8
Study feasibility Assessment
Site Qualification & Site selection and initiation
9
Ethics committee/ Regulatory pathway
A. IRB/IEC
B. Conflict of interest,
C. Confidentiality,
D. Vulnerable population,
E. Informed consent procedure
10
Managing, Handling and Accountability of Investigational products and critical supply chain elements
11
Good Clinical Practice (ICH E6)
12
New Drug Clinical Trial Rule (NDCT)
13
Indian Council of Medical research (ICMR) Guideline
14
Basic Orientation to Regulatory Bodies (DCGI, EMA, MHRA, USFDA)
15
Good Documentation Practices
A. Data entry, principles of ALCOA+
B. Discrepancy management
C. Data privacy and storage
D. Case Studies
16
Trial master file –Set up & maintenance, Key attributes practical aspects and challenges
17
Informed consent Procedure & Case Studies
18
Patient/Participant Recruitment, Retention, and Compliance
19
Log / forms / templates used in Clinical Trial
20
Guidelines for Reporting of AE/SAE
21
Site Monitoring - Study oversight and compliance & managing deviations
22
Audit Plan, Audit & Audit report
23
Study closure/Site Close Out
24
Basic orientation on various guideline and regulation (21 CFR Part11 ,21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 320, Declaration of Helsinki)
25
Overview of Clinical Data Management (CDM) in clinical trial
26
CTRI & Importance of Various Regulatory Forms
27
Various job role in CT and roles and Responsibility
28
Clinical Trial Site Visits
29
Communication & Public Speaking Workshop
30
Industry Expert Sessions
31
Career Counseling
A. Expert HR Lecture
B. Mock Interviews
C. Personal Mentoring
D. Social Media Guidance
E. Interview Do’s and Don’ts
F. CV Preparation
G. Email Etiquette
32
MCQ based final Exam
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
Courses
Contact us
- 2nd floor, 17, Sigma Corporates, Sindhubhavan road, Opp. Courtyard Marriott, Bajarang Cross road, Ahmedabad, India, Gujarat
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
Courses
Contact us
- 2nd floor, 17, Sigma Corporates, Sindhubhavan road, Opp. Courtyard Marriott, Bajarang Cross road, Ahmedabad, India, Gujarat
Duration : 250 Hours
Mode : Online/Offline/Hybrid
Course Overview
- 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 executio
- Study close out, analysis, reporting
- It is designed to include the Point of view of all stakeholders in a regulated clinical trial Sponsor
- Sponsor
- Investigator / Sites
- 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, site visits and Interaction/Session with Industry Expert.
- 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.
- 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.
- 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.
- Post training, Final assessment / Exam for each participant will be done before concluding the training as successful