Integrated Clinical Trials and Safety Reporting

This course offers comprehensive training on clinical trials in medical devices, decentralized clinical trials, patient narrative authoring, ethics committee training for safety reporting, and serious adverse event reporting via the SUGAM portal. It covers regulatory requirements, project management, and automation in patient narratives, ensuring thorough understanding and compliance in clinical research practices.

Module 1 : Clinical Trials in Medical Devices

  • Clinical Evaluation of Medical Devices
  • Medical Devices India
  • Classification Rules
  • Indian Rules and Types of Devices
  • Regulatory Requirements
  • Investigational Medical Device

Module 2 : Decentralized Clinical Trials

  • Introduction to Decentralized Clinical Trials
  • Recruitment
  • Electronic Consent
  • Dispensing and Accountability for Investigational Product
  • Decentralized Clinical Trial

Module 3 : Patient Narratives

Introduction to Patient Narratives

  • Overview of Patient Narratives and Regulatory Guidance
  • Narrative Requirements (Narrative Criteria and Types)

Project Management

  • Project Management in Patient Narratives Development
  • Understanding the Scope of Project Management
  • Roles of LNW (Lead Narrtive Writer) -kick off Meeting, LNW-Operations and Cross Functional Team
  • Challenges in Patient Narratives Project Management
  • Patient Narratives Preparation Workflow Steps
  • Discussion

Source Documents for Patient Narratives

  • Source Documents/ Definition and General Overview
  • Types of Source Documents (Clinical/Safety/Other)
  • Source Documents Associate with Types of Narratives and Categories
  • Data Included from Clinical and Safety database
  • Interpretation of Relevant Data from Source Documents

Structure and Consent of Patient Narratives

  • Baseline Characteristics
  • Medical History and Concurrent Conditions
  • Concomitant Medications
  • Study Drug Exposure and Baseline Lab Data
  • AE (Adverse Event) Description
  • Treatment for Event of Interest
  • Study Drug and Study Disposition
  • Investigator and Sponsor Causality

Patient Narrative and Automation

  • Automation in Regulatory Documents
  • Manual/Conventional Process of Writing PN
  • Automation as Solution

Module 4 : Ethics Committee Training for Safety Reporting

  • Ethical Council
  • Historical Guidelines of Ethical Developments and GCP (Good Clinical Practice): An Overview
  • GCP (Good Clinical Practice): 3 Key Players
  • Conduct of CT (Clinical Trials)
  • SAE Reporting
  • Compensation in Clinical Trail and Biomedical Research
  • NDCT (New Drug Clinical Trials) 2019
  • Course on Medical Device Investigator Initiated Study

Module 5 : Serious Adverse Event Reporting over the SUGAM Portal

Investigator Training :

  • What is SUGAM Portal?
  • Video Tutorial by CDSCO (Central Drug Standard Control Organization)
  • Due Analysis Report
  • Setup of CT in SUGAM portal by Sponsor
  • Steps taken by Sponsor and Investigators
  • SAE (Serious Adverse Event) Reporting by Investigator
  • SAE Reporting for CT NOC (No Objection Certificate) issued in SUGAM Portal (Official CT)
  • SAE Reporting by Sponsor – 14 Day Report
  • SAE Reporting by Ethics Committee – 30 Day Report
  • Important Information

Sponsor Training :

  • What is SUGAM Portal?
  • CDSCO Office order dated 25 February 2021
  • Video Tutorial Links
  • SAE Reporting for CT NOC (No Objection Certificate) issued in SUGAM Portal (Official CT)
  • Setup Process of a Clinical Trial in SUGAM SAE Module
  • Process Flow
  • Setup of Clinical Trial by Sponsor
  • Steps to be taken by Investigator and Sponsor
  • Clinical Trial SAE Reporting process
  • SAE Reporting for Offline Clinical Trial
  • SAE Reporting (14- Day Report Sponsor)
  • SAE Reporting for – Clinical Trial NOC (No Objection Certificate) issued in SUGAM Portal
  • What is SAE Reporting for Offline Clinical Trial?
  • SAE Reporting by Investigator – 24 hours
  • SAE Reporting by Investigator – 14 CD due Analysis Report
  • SAE Reporting by Ethics Committee – 30 Day Report

Certificate In FCPM [ Online ]

Duration : 4 hrs/ week (2 days/week)

Schedule : Session of 2 hours twice a week

Batches Starting From August 2024​

Enroll Now For Early Bird Offers ( 10% Discount In Both Modes )

Certificate In FCPM [ Offline ]

Duration : 4 hrs/ week (2 days/week)

Schedule : Session of 2 hours twice a week

Perks Of Offline Course

Role Play
Get to work on live projects
Face-to-face guidance by PM
Clinical on-site exposure