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Basic Course in Good Clinical Practice

	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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