CLINICAL TRAILS MANAGEMENT

Global Institute of Health Science is a pioneer in health science education especially in distance & online education. Global Institute of Health Science is an ISO 21001:2018 Certified health science Institute & globally acclaimed, also certified with copyright approval from IPR Government of INDIA. GIHS have international certification from UASL UK for Quality Control Management System.

WHY CHOOSE US

• BRINGING EXCELLENCE TO HEALTH PROFESSIONALS
• 10+ YEARS OF EXPERIENCE WITH INTERNATIONAL EXPOSURE
• INTERNATIONAL ACLAIMED WITH ISO & GOVT APPROVED
• LIFETIME FREE PERSONALIZED TUTORING FOR SUCCESS

Clinical Trials Management a branch of medical science and research that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use.

These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical Trials is different than clinical practice.

In clinical practice, one used established treatments while in clinical trials evidence is collected to establish a treatment.

This GIHS Clinical Trials Management Program designed to provide total overview and skill globally in the field of Clinical Trials.

It would help professionals to upgrade & develop their knowledge about ICH GCP Guidelines, regulatory issues and other major aspects of clinical research & trial management

It can be able applicable to critically appraise the medical scientific literature, including the methodology of published and proposed investigations

SYLLABUS

Clinical Trails Management

Introduction of clinical research

• Clinical Trial Phases / Pharmacological Principal of Clinical Research
• Drug Development and Launch

Indian Regulation (domestic regulation)

• ICH GCP / Schedule Y / ICMR / Indian GCP

Key Stakeholders in Clinical Research

• Ethics Committees and Institutional Review Board
• Responsibilities of Sponsor / Responsibilities of Investigator
• Responsibilities of Sponsor – Investigator / Responsibilities of Sponsor – Vendor

Clinical Trial Design and Project Managements

• Clinical Trial Design / Vendor Selection and Managements
• Project Planning / Project Managements

Principles of good clinical practices

• Protocol Design / CRF Design

Essential documents in clinical research and regulatory requirements

• Essential Documents / IND Application / Clinical Study Report
• NDA Application / Informed Consent Process and Documentation

Study setup process

• Site Selection and Pre- Study Visits
• Site Initiation / Subject Recruitment and Retention Planning
• Site Contract and Budgeting

QC, Compliance & Auditing in Clinical Research

• 21 CRF Part 11 / Site Auditing
• Sponsor Compliance and Auditing / SOP for Clinical Research

Clinical Monitoring

• CRF Review & Source Data Verification
• Drug Safety Reporting / Drug Accountability Work
• Routine Site Monitoring / Site Close Out Visit

Introduction of Pharmacovigilance

• Overview of Pharmacovigilance
• Standard Terms and Terminology in Pharmacovigilance

Medical Evaluation of Adverse Events in Pharmacovigilance

• Adverse Event Reporting System and Form
• Diagnosis and Managements of ADRs / Medical Evaluation of AE

Case Processing

• Global Perspective of Pharmacovigilance
• Single Case Processing / Case Narrative Writing

Pharmacovigilance Reporting Database, Signal Detection, Managements and Risk Assessments & Evaluation

• Quality System in PV / Expedited Reporting Criteria
• PSUR & PBRER / PV Database and Signal Detection
• Risk Assessments & Management

Medical Dictionary for Regulatory Activities medDRA

• medDRA

PV laws and Guideline

• Regulatory Guideline @ Laws in PV / SOPS in PV / PV Auditing And Inspection
• Regulatory Aspects In PV

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