Basic Course in Good Clinical Practice

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The agenda proposal aside has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

Agenda Proposal

  Content Day 1
08:00 – 08:30 Welcome and Introduction
08:30 – 09:30 Introduction to Clinical Drug Development – From Mouse to Man
  • Interfaces between preclinical and clinical development
  • Objectives of clinical trials
  • Phases of clinical trials: Phase I – II – III - IV
09:30 – 10:45

Regulations for Clinical Trials – Part 1: International

  • Declaration von Helsinki
  • International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS)
10:45 – 11:00 Break
11:00 – 12:30 Regulations for Clinical Trials – Part 2: ICH
  • ICH GCP (ICH E6): Responsibilities of
    • Ethics committees
    • Clinical investigators
    • Sponsors
    • Monitors
    • Auditors
  • Inspectors E2A – Expedited Safety Reporting
  • E3 – Clinical Study Report
  • E8 – General Considerations for Clinical Trials
  • E9 – Statistical Principles in Clinical Trials
  • E10 – Choice of Control Groups
12:30 – 13:30 Lunch
13:30 – 14:30 Regulations for Clinical Trials – Part 3: Europe
  • Clinical Trials Directive 2001/20/EC
  • GCP Directive 2005/28/EC
  • GMP Directive 2003/94/EC
14:30 – 15:30 Regulations for Clinical Trials – Part 4: US
  • 21 CFR Part 11: Electronic Records, Electronic Signatures
  • 21 CFR Part 50: Protection of Human Subjects
  • 21 CFR Part 54: Financial Disclosure by Clinical Investigators
  • 21 CFR Part 56: Institutional Review Boards
  • 21 CFR Part 312: Investigational New Drug Application
15:30 – 15:45 Break
15:45 – 16:45 Key Documents in Clinical Trials – Part 1: Role, Structure, Content
  • Investigator’s Brochure
  • Study Protocol, Protocol Amendments
  • Subject Information Sheet and Informed Consent Form
  • Case Report Form
  • Trial Report
16:45 – 17:30 Key Documents in Clinical Trials – Part 2: Document Quality
  • Common errors or weaknesses
  • Quality control procedures
  Content Day 2
08:30 – 09:15 Monitoring and Managing Clinical Trials – Part 1
  • Role and Responsibilities of Clinical Monitors
  • Investigator Site Selection and Qualification
  • Pre-Study Site Visit
  • Study Initiation Visit
  • Interim Monitoring Visit
  • Close-Out Visit
09:15 – 10:30 Workshop: Preparation, Conduct and Follow-Up of Monitoring Visits
10:30 – 10:45 Break
10:45 – 11:30 Monitoring and Managing Clinical Trials – Part 2
  • Documentation of Monitoring Visits: Monitoring Report
  • Communication with Investigator Sites, Sponsor, Project Team, Contract Research Organizations (CROs), External Providers etc.
  • Status Reporting
  • Management of Time, Quality, Budget
11:30 – 12:30 Safety Reporting in Clinical Trials
  • Distinctions between AE, SAE, ADR, SADR, SUSAR
  • Seriousness, Expectedness, Relatedness of AEs
  • Reporting Requirements and Timelines
  • EudraVigilance Clinical Trial Module
  • Documentation
12:30 – 13:30 Lunch
13:30 – 14:45 GCP Quality Management System
  • Components of a modern GCP Quality Management System
  • Quality Control and Quality Assurance: Roles, Responsibilities, Differences
  • Compliance in Clinical Trials
  • Conducting QA Audits: Audit Types, Preparation, Conduct, Reporting and Follow-Up, Interaction between Auditor and Auditee
14:45 – 15:30 Case Studies: GCP Audit Observations
15:30 – 15:45 Break
15:45 – 16:45 Standard Operating Procedures in Clinical Research
  • GCP Requirements for SOPs
  • Writing practical and easy-to-understand SOPs
  • SOP Lifecycle Management – from draft to archiving
  • Role of SOPs in Audits and Inspections
  • SOP Weaknesses
16:45 – 17:30 GCP Inspections
  • Audits and Inspections: Purpose and Differences
  • Purpose, focus and time point of GCP inspections
  • Overview on inspection processes and approaches
    • How to prepare for a GCP inspection
    • How to facilitate and behave during an inspection
    • How to follow-up after an inspection
    • How to respond to inspection reports

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