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Medical
Clinical Trails Managment
Clinical Trails Managment
Curriculum
5 Sections
22 Lessons
12 Weeks
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Module 1: Introduction to Clinical Trials (Week 1-2)
4
1.1
Overview of Clinical Research & Drug Development
1.2
Clinical Trial Phases (Phase I-IV) & Study Designs
1.3
Good Clinical Practice (GCP) & Regulatory Guidelines (ICH, FDA, EMA)
1.4
Hands-on: Case Study on Real Clinical Trials
Module 2: Ethical & Regulatory Aspects (Week 3-6)
4
2.1
Institutional Review Board (IRB) & Ethics Committees
2.2
Regulatory Submissions (IND, NDA, ANDA, BLA)
2.3
FDA, EMA, DCGI Guidelines for Clinical Trials
2.4
Hands-on: Prepare an IRB Submission Document
Module 3: Clinical Trial Protocol & Study Design (Week 7-10)
4
3.1
Writing & Reviewing Clinical Trial Protocols
3.2
Subject Recruitment, Randomization & Blinding
3.3
Site Selection & Investigator Responsibilities
3.4
Hands-on: Design a Clinical Trial Protocol & Informed Consent Form (ICF)
Module 4: Project Management (Week 11-14)- 8 hours
5
4.1
Project Initiation, Planning and Execution
4.2
Monitoring, closing and focusing on communication
4.3
Role of Project Management Specialists and Clinical Research Associates (CRAs)
4.4
Stakeholders approach for successful adoption of projects.
4.5
Hands-on: To Manage the projects from start to end and CTMS skills.
Module 5: Records Information Management-Electronic Trial Master File (eTMF) (Week 15-18)- 9 hours
5
5.1
Essential Documents (E6 Guidelines) in Clinical Research
5.2
Documents Workflow process and databases used to manage eTMF.
5.3
Documents Identification, collection and quality parameters (ALCOA).
5.4
DIA eTMF reference Model, Milestones, Inspection readiness for the clinical Trial studies.
5.5
Hands-on: Applying and managing metadata to the clinical trial documents using TMF Index in different eTMF databases.
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