Clinical Research Monitoring And Good Clinical Practice Certification
This course provides a detailed exploration of Good Clinical Practice (GCP) obligations for sponsors and monitors, ethical considerations, and regulatory document management. It covers the development and principles of GCP, informed consent, institutional review boards, and new HIPAA regulations. Additionally, it addresses investigator recruitment, site selection, protocol procedures, monitoring types, and essential site initiation activities, including remote monitoring and compliance with regulatory requirements.
Module 1 : Overview GCP-Obligations of Sponsors or Monitors
– What is Good Clinical Practice?
– What Constitutes Good Clinical Practice?
– Immense Change in the Industry
– The Drug Development Process
– Good Clinical Practice
– How GCP (Good Clinical Practice) was Developed?
– What are the Goals of GCP (Good Clinical Practice)?
– What are the 13 Principles of ICH – GCP?
– International Organization for Standardization
– ISO – GCP for Device Trials
– Who is Responsible for GCP Compliance?
– FDA Guidance Documents
Module 3 : Regulatory Document Review and Management
- Investigator Recruitment or Site Selection
– Regulatory Document Review and Management
– Essential Regulatory Documents
– Delegation of Authority Log
– Key Term Differences Between Device and Pharma Trials
– Investigator/ Site Selection
– Study Conduct Risk and Inefficiency
– Elements of Successful Site
– Site Qualification Visit
- Site initiation activities, monitoring activities and site visits
– SQV (Site Qualification Visit) – PK (Pharmacokinetics) Specifics
– SQV (Site Qualification Visit) – Source Documents
– SQV (Site Qualification Visit) – EMR (Electronic Medical Record)
– Case Studies
– Consent Form Required Elements
– Site Visits
– Informed Consent Process
Module 2 : Ethical Considerations, Informed Consent
– What are the Foundations of the Conduct of Clinical Research?
– What is Research with Human Participants?
– Clinical Trial Volunteer’s Bill for Human Rights
– Institutional Review Board
– New HIPAA (Health Insurance Portability and Accountability Act) Regulations
– Financial Disclosure
– Informed Consent
Module 4 : Protocol and Procedures
- Protocol Deviations, Types of Monitoring
– Protocols and Procedures – SIV (Site Initiation Visit)
– Protocols and Procedures – IMV (Interim Monitoring Visit)
– Protocol Violations/ Deviations
– Investigational Product Management – SIV (Site Initiation Visit)
– Source Documents and Study Data – SIV (Site Initiation Visit)
- Facilitating Remote Monitoring, Risked Based Monitoring
– Concomitant Medications – SIV (Site Initiation Visit)
– Adverse Events
– Subject Recruitment and Retention – SIV (Site Initiation Visit)
– Study Supplies and Equipment – SIV (Site Initiation Visit)
– Visit Report and Follow – up
– Facilitating Remote Monitoring Access and HIPAA Considerations
– What about Business Associate Agreements?
– Creating a Certified Copy Process
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
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