Clinical Data Management

Learning Objectives

Clinical data managers supervise all aspects of program-related data, from design and framework to collection, processing, storage, retrieval, and more, maintaining compliance with FDA and other regulations after completion of this training program, you will be able to:

• Understand the principles of Clinical Research and its methodology

• Understand the Basics concepts of Pharmacovigilance and its historical perspective

• Various guidelines related to Pharmacovigilance (ICH, CIOMS and GVP)

• End to End knowledge about Individual Case Safety Reporting (which included case book- in, duplicate search, triage, case processing, clinical coding, narrative writing, quality review, medical review, and submission to Regulatory Authorities)

• Practical knowledge of clinical coding using different software/tools like MedDRA, WHODD, COSTART etc.

• Understand the various types of Aggregate Reports, and its reporting structure and timelines

Curriculum/Services

Module I Pharmacovigilance

• Introduction

• Historical Overview

• Basic principles of Pharmacovigilance in Clinical Trials

• Methodologies for Pharmacovigilance

Performance evaluation.

Module II Regulations in Pharmacovigilance in Clinical Research

• FDA and EU perspectives

• Drug Regulatory Activities MedDRA

• Regulatory Aspects in Pharmacovigilance

• EudraVigilance

• Regulations in Pharmacovigilance in Clinical Research

Performance evaluation.

Module III Adverse Drug Reactions and Safety Reports

• ADR Reporting

• Causality Assessment of Suspected Adverse Drugs Reactions

• Periodic Safety Update Reports (PSURs) For Marketed Drugs (ICH E2C)

• Expedited Reporting Requirements · Individual case safety reports

• Periodic safety update reports

• Electronic safety reporting

• WHO & safety monitoring

Performance evaluation.

Module IV Signal Analysis

• Definition of signal and type of signal

• Conducting signal detection in clinical and post-marketing surveillance

• Defining movement concerning risk/benefit

• Signal generation to decision making

• Signal Detection Tools

• Understanding signals & benefit-risk determinations

Performance evaluation.

Module V Compliance to Clinical Safety and Pharmacovigilance Regulations

• Review of benefit-risk assessments and management

• Scope of Pharmacovigilance inspection and conduct of inspection

• An internal audit of pharmacovigilance activities of a company

• Pharmacovigilance inspection reports

• Pharmacovigilance compliance and inspection

• Quality System in Pharmacovigilance: Good Practices, SOPs, Preparation for Audits & Inspections

• Scope of Pharmacovigilance inspection and conduct of inspection

• Key Functionalities of the Adverse Event Systems

Performance evaluation.

Module VI Pharmacovigilance Management and Importance

• Pharmacovigilance Database

• Setting up a Pharmacovigilance Centre in Industry

• Management of Pharmacovigilance Data

• Risk Management in Pharmacovigilance

• Data management & software solutions

• Effective communication in pharmacovigilance

• Pharmacovigilance in special situations

Final assessment.

Requirements

The minimum eligibility criteria for the Professional course in Clinical Data Management would include either of the following:

• Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology, etc.

• Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS, etc.

• Any degree in Pharmacy / Pharmaceutical Sciences.

• Any degree in Chemistry / Biostatistics / Bioinformatics.

• Any degree in Nursing / Allied Health.

• Students in their final year of graduation for the above courses are also eligible to apply.

• Pharmacovigilance in special situations

If you are interested in Clinical Data Management, we are happy to assist you through the process.

Download the course pdf for a detailed understanding before you begin your Clinical Data Management Training with us!