Clinical Research Coordinator Certification Program

The module covers the role of a Clinical Research Coordinator (CRC), including their responsibilities, challenges, and opportunities. It provides an overview of clinical development, regulatory history, and guidelines such as ICH-GCP and Indian GCP. Additionally, it details study preparation, documentation management, stakeholder collaboration, study closure, safety management, inspection readiness, and adapting to changes in the clinical research landscape.

Module 1 :

Who is CRC (Clinical Research Coordinator)?

  • CRC (Clinical Research Coordinator) Personality
  • Locations
  • Responsibilities
  • Challenges and Opportunities

Responsibilities of CRC (Clinical Research Coordinator)

  • Trial Phases Breakdown
  • Protocols
  • Co-ordination
  • Challenges

Clinical Development Overview

  • Discovery: Drug Discovery and Development
  • Definitions: Definitions of Clinical Trial
  • Phases: Phases of Clinical Trial
  • Design: Study Designs

History and Regulations

  • Research: Early Medicine and Research
  • Evolution: Historical Events and Evolving Regulations
  • ICH-GCP: Evolution of ICH-GCP and Local Guidelines/Regulations
  • Updates: Dynamic Updates with Changing Landscape

ICH GCP (Good Clinical Practice), Indian GCP (Good Clinical Practice), New Drug Rules

  • Definition: GCP (Good Clinical Practice) Definition and Harmonization
  • Regulatory: Understanding of Regulatory Pyramid
  • Key Aspects of:

– ICH GCP (Good Clinical Practice)

– Indian GCP (Good Clinical Practice)

– New Drug and Clincal Trial Rules, 2019

– Indian Medical Device Regulators

  • Development of SOPs

– Definition of SOPs

– Need for SOPs

– Document Hierarchy

– Developing SOPs Including Sample SOP Structure

– Implementation of SOPs

– Maintenance and Continuous Improvement of SOPs

– Relevant Topics for Site Specific SOPs

Module 2 :

Preparing for the Study

  • Feasibility Process – Understanding and Expectations
  • Site Evaluation / Selection
  • IRB (Institutional Review Board) / IEC (Independent Ethics Committee) Communication
  • Management of Clinical and Ancillary Supplies
  • Investigator Meetings
  • Making the Site for Patient Screening – Vendors, Logistics, Access etc.
  • Site Initiation Visit

Managing Study Documentation

  • Good Documentation Practices e.g., ALCOAC (Attributable, Legible, Contemporaneous, original, Accurate, Consistent)
  • Essential Documents Required During Startup, Conduct and at the Closure
  • Other Administrative Documentation
  • Archival

Working with Stakeholders

  • Key Stakeholders
  • Roles and Responsibilities of Stakeholders
  • Working and Building Relationships with Stakeholders
  • Challenges and Opportunities

Module 3 :

Closing the Study

  • What is Study Closure?
  • Planning for Study Closure
  • Study Closure Conduct
  • Post Close – out Activities

Working with Stakeholders

  • Key Stakeholders
  • Roles and Responsibilities of Stakeholders
  • Working and Building Relationships with Stakeholders
  • Challenges and Opportunities

Safety Management

  • Importance of Safety Management
  • Terminologies in Safety Management
  • Safety Reporting Process
  • CRC’s (Clinical Research Coordinator) Responsibilities in Safety Management

Inspection Readiness

  • Define Inspection and its Objectives
  • Who can be Inspected?
  • Typical Selection Criteria’s of Inspection
  • Preparation for an Inspection
  • During and Post Inspection Responsibilities
  • Do’s and Don’ts
Certificate In FCPM [ Online ]

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

Schedule : Session of 2 hours twice a week

Batches Starting From 

August 2024
Enroll Now For Early Bird Offers
in Both Mode
Certificate In FCPM [ Offline ]

Duration : 4hrs / 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 (Project Manager)

Clinical on-site exposure

Enroll Now