ISO 14155 : Clinical investigation of medical devices for human subjects

This ISO 14155 course provides a comprehensive overview of clinical research standards and ethical considerations, highlighting the scope, planning, conduct, and closeout of clinical investigations. It delves into the responsibilities of sponsors and principal investigators, emphasizing adherence to Good Clinical Practice (GCP) principles, ensuring participant safety, and maintaining regulatory compliance throughout the study lifecycle.

Module 1 : Scope

  • Background of ISO14155 Versus other GCP Documents
  • Scope of ISO14155
  • Applicability of ISO14155
  • Summary of the GCP Principles

Module 3 : Clinical Investigation Planning

  • Risk Assessment

– Investigational Device and its Inherent Procedure

– Clinical Investigation Procedure

– Justification of Investigation Design

  • Essential Documents

– Clinical Investigation Plan / Annex A

– Investigator Broucher / Annex B

– Case Report Form / Annex C

  • Monitoring Plan
  • Site Selection
  • Agreements
  • Labelling
  • Data Monitoring Committee

Module 4: Clinical Investigation Conduct

  • Initiation and Monitoring
  1. Adverse Event and Device Deficiencies
  • Signals Requiring Immediate Action
  • Adverse Event
  • Device Deficiencies
  • Documents and Documentation

– Subject Identification Log

– Source documents

  • New Site Personnel
  • Subject Privacy and Confidentiality
  • Documents and Data Control

– Traceability of Documents and Data

– Recording of Data

– Electronic Clinical Data System

  • Accounting of Subjects
  • Auditing

Module 6 : Responsibilities Sponsor

  • Quality Assurance

– Selection of Clinical Personnel

– Documents and Material Preparation

– Clinical Investigation Conduct

– Monitoring

  • General Guidelines and Monitor Qualification
  • Initiation of the Investigation Site
  • Monitoring

– Routine On-Site Visit

– Safety Evaluation and Reporting

– Clinical Investigation Close Out

– Outsourcing of Duties and Functions

– Communication with Regulatory Authorities

Module 2 : Ethical Consideration

  • Improper Influence or Inducement
  • Compensation and Additional Healthcare
  • Registration of publicly accessible database
  • Responsibilities
  • Ethics Committee

– Initial EC Submission

– Information to be Obtained from EC

– Continuing Communication with the EC

– Continuing Information Obtained from the EC

  • Annex G
  • Vulnerable Population
  • Informed Consent

– Process of Obtaining Consent

– Special Circumstances for Informed

– Information to be Provided to Subject

– New Information

Module 5 : Clinical Investigation Closeout

  • Completion of the Clinical Investigation
  • Premature Termination and Suspension
  • Routine Closeout
  • Clinical Investigation Report – Annex D
  • Risk Assessment and Conclusion
  • Document Retention

Module 7 : Responsibilities of Principle Investigator

  • Roles and Function

– Qualification of PI

– Qualification of Investigation Site

– Communication with the EC

– Informed Consent Process

  • Compliance with the CIP
  • Medical Care of Subjects

– Safety Reporting

Certificate In FCPM [ Online ]

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

Schedule : Session of 2 hours twice a week

Batches Starting From August 2024​

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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