GCP

International GCP Training

The course is accredited for 6.5 CPD credits. This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

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Why enroll in this course?

Course Syllabus

  • What is GCP
  • Why do we need GCP
  • Historical disasters
    • Elixir incident
    • Tuskegee syphilis experiment
    • Guatemala syphilis experiment
  • Historical background of GCP
  • Nuremberg code
  • Declaration of Helsinki
  • The International Conference on Harmonization
  • KNOWLEDGE CHECKPOINT
  • Reasons for GCP
  • 13 Core principles of ICH-GCP
  • KNOWLEDGE CHECKPOINT
  • Things to remember from Chapter 1
  • Independent Ethics Committees – definition and purpose
  • Institutional Review Board – definition and purpose
  • What is the difference between IEC and IRB
  • Composition of IEC/IRB
  • KNOWLEDGE CHECKPOINT
  • Functions of IEC/IRB
  • Conflicts of interest
  • Local and central IECs/IRBs
  • IEC/IRB authority
  • Responsibilities of IEC/IRB
  • KNOWLEDGE CHECKPOINT
  • Procedures of IEC/IRB
  • Criteria for approval of research – The Belmont Report
  • Records
  • Things to remember from Chapter 2
  • Investigator – definition
  • Sub-investigator – definition
  • Key responsibilities
  • Compliance with protocol
  • Deviation from protocol
  • KNOWLEDGE CHECKPOINT
  • Medical care of trial subjects
  • Communication with IRB/IEC
  • Investigational Medicinal Products (IMPs) – definition
  • Investigator and IMPs
  • Records and reports
  • Randomization procedures and unblinding
  • Premature termination or suspension of a trial
  • Investigator’s brochure – definition, structure, examples
  • KNOWLEDGE CHECKPOINT
  • Things to remember from Chapter 3
  • Informed consent – definition
  • How to deliver the information
  • Informed consent of trial subjects
  • Legally acceptable representative – definition
  • Impartial witness - definition
  • Informed consent process
  • Steps in informed consent process
  • Necessary explanations
  • Things to consider before the trial
  • KNOWLEDGE CHECKPOINT
  • Vulnerable and special populations
  • Informed consent and vulnerable populations
  • Informed consent of special population
  • Informed consent in emergency situations
  • Informed consent of Incapacitated subjects
  • Informed consent of Minors
  • KNOWLEDGE CHECKPOINTS
  • Informed consent document – definition, structure, examples
  • Common errors with consent forms
  • Things to remember from Chapter 4
  • Definition
  • Quality Management
  • Quality control and quality assurance
  • Medical expertise
  • Trial design
  • Data handling
  • Electronic trial data handling
  • KNOWLEDGE CHECKPOINT
  • Investigator selection
  • Allocation of responsibilities
  • Compensation to subjects and investigators
  • Trial financing
  • Submission to regulatory authorities
  • Sponsors and investigational Products (IPs)
    • Manufacturing, packaging, labelling and coding IPs
    • Supplying and handling IPs
    • Record access
  • KNOWLEDGE CHECKPOINT
  • Multicenter trials
  • Things to remember from Chapter 5
  • Definition
  • Purpose
  • Selection and qualification of monitors
  • Monitoring Approach
  • Responsibilities
  • KNOWLEDGE CHECKPOINT
  • Monitoring report – structure and examples
  • Things to remember from Chapter 6
  • Definition
  • Purpose
  • Protocol Content and detailed explanations of each section
    • General information
    • Background information
    • Trial objectives and purpose
    • Trial design
    • Types of trial designs
    • Selection and withdrawal of subjects
    • Informed consent form process
    • Adverse event reporting
    • Treatment of subjects
    • Assessment of safety and efficacy
    • Statistics
    • Data collection plan/data access
    • Quality control and quality assurance
    • Ethics
    • Data handling and record keeping
    • Financing and insurance
    • Publication and presentation plans
    • Timeline
    • References
  • KNOWLEDGE CHECKPOINT
  • Protocol amendments – definition and examples
  • Types of protocol amendments
  • Protocol deviation – definition and examples
  • Protocol violation – definition and examples
  • KNOWLEDGE CHECKPOINT
  • Things to remember from Chapter 7
  • Recording data in clinical trials
  • Source data
  • Source documents
  • What data is documented
  • ALCOA principle
  • Requirements for electronic source records
  • Case Report Form – definition and purpose
  • CRF relation to protocol
  • CRF and source data
  • An approach to CRF design
  • Questions style
  • Audit trails
  • CRF changes and corrections – how to make a correction
  • Handling missing data
  • CRF structure – sections and examples
  • KNOWLEDGE CHECKPOINT
  • Safety data
  • Adverse event
  • Adverse drug reaction – definition and examples
  • Serious Adverse event – definition and examples
  • Serious adverse drug reaction – definition and examples
  • How to identify SAE
  • Unexpected Adverse drug reaction – definition and examples
  • SUSAR – definition and examples
  • Criteria for SUSAR
  • Managing ADRs
  • KNOWLEDGE CHECKPOINT
  • Reporting of adverse events
  • Reporting of serious adverse events
  • Reporting of adverse drug reactions and SUSARs
  • CIOMS-I form
  • Progress reporting
  • Final reports
  • Things to remember from Chapter 8
  • Definition and purpose
  • Clinical trial master file
  • Types of essential documents
  • Essential documents before the clinical phase of the trial commences
  • Essential documents during the clinical conduct of the trial
  • Essential documents after completion or termination of the trial
  • Additional essential documents
  • Things to remember from Chapter 9

Ready to get started?

€59 Enroll