Overview of Clinical Research & Drug Development

Clinical Trial Phases (Phase I-IV) & Study Designs

Good Clinical Practice (GCP) & Regulatory Guidelines (ICH, FDA, EMA)

Hands-on: Case Study on Real Clinical Trials

Institutional Review Board (IRB) & Ethics Committees

Regulatory Submissions (IND, NDA, ANDA, BLA)

FDA, EMA, DCGI Guidelines for Clinical Trials

Hands-on: Prepare an IRB Submission Document

Writing & Reviewing Clinical Trial Protocols

Subject Recruitment, Randomization & Blinding

Site Selection & Investigator Responsibilities

Hands-on: Design a Clinical Trial Protocol & Informed Consent Form (ICF)

Essential Documents (E6 Guidelines) in Clinical Research

Documents Workflow process and databases used to manage eTMF.

Documents Identification, collection and quality parameters (ALCOA).

DIA eTMF reference Model, Milestones, Inspection readiness for the clinical Trial studies.

Hands-on: Applying and managing metadata to the clinical trial documents using TMF Index in different eTMF databases.