Good Clinical Practice: Conducting Clinical Trials

Introduction to clinical trials

• Aims of clinical trials
• Phases of clinical and epidemiological studies
• Milestones in clinical projects (design, implementation)

International ethical principles and guidelines

• History of and milestones in clinical research
• Nuremberg Code
• Declaration of Helsinki Good Clinical Practice (GCP) guidelines
• General principles of GCP
• ICH-GCP E6 (or regionally adapted GCP regulations)

Roles and responsibilities in clinical trials

• GCP responsibilities of the investigator
• GCP responsibilities of the sponsor and CRO
• GCP responsibilities of the monitor
• Standard Operating Procedures (SOP)

Applicable regional and/or national laws and guidelines

• Applicable regional and/or national drug laws and related guidelines
• Local requirements concerning the conduct of clinical trials
• Local requirements concerning the enrollment of subjects
• Organization of Ethics Committees and Regulatory Authorities
• Requirements of Ethics Committees concerning the conduct of clinical trials
• Local and country specific regulations (e.g. data protection, insurance)
• Label requirements

Essential documents

• Protocols
  • Content of a protocol
  • Inclusion and exclusion criteria
  • Study procedures
  • Flowchart
• Informed Consent Form (ICF)
  • Content of an ICF
  • Informed Consent process
  • Procedures and legal requirements for sensitive subject populations
• Investigator’s Brochure (IB)

Submission and approval processes

• Ethics Committees and Regulatory Authorities
  • General information and composition
  • Submission and approval process
  • Which is the responsible IRB/IEC?
  • Which is the responsible Regulatory Authority?
  • Timelines
  • Different types of investigational medicinal product

Site selection and pre-study visit

• Site recruitment strategies
• Feasibility studies
• Confidentiality agreement
• Aims of site pre-study visits
• Key documents at qualification

Site initiation

• Aims of site initiation visits
• Key documents and materials at initiation
• Electronic portals and tools

Monitoring and adverse event reporting

• Aims of site monitoring visits
• Case Report Forms and source data verification
• Queries
• Study medication and drug accountability
• Safety reporting
• Investigator Site File Study

Logistics

• Logistics of investigational medicinal products
• Labeling of investigational medicinal products
• Laboratory: central or local lab

Close-out visit

• Aims of site close-out visits
• Regular or early termination: timelines

Audits and inspections

• Archiving audits and inspections
• Event-triggered vs. routine checks
• Sponsor inspections
• EMA / FDA and foreign authority inspections
• Audit preparation and training
• Behavior during audits and inspections
• Findings and consequences
• Inspection reports