Good Clinical Practice Basic Training Topics

Theoretical Presentations
  • Essential Concepts in Clinical Research
  • History of Clinical Research and Ethics
  • Global and Local Regulations
  • Helsinki Declaration and Good Clinical Practice
  • Design in Clinical Trials
  • Methods in Clinical Trials
  • Clinical Trial Protocol
  • Responsibilities of Parties in Clinical Trials
  • Responsibilities of the Sponsor
  • Budget and Insurance
  • Investigator’s Responsibilities
  • Responsibilities of the Ethical Committee
  • Safety Reporting in Clinical Trials
  • Case Report Form and Source Data
  • Ethical Principles in Scientific Research and Publications
  • Why do we do Research?
  • Retrospective Studies
  • Observational Studies
  • Medical Device Clinical Trials
  • Pediatric Clinical Trials
  • Essential Strategies in Clinical Trials (superiority, equivalence, non-inferiority)
  • Biomarkers in Clinical Research
  • Latest Developments in Clinical Research
Workshops
  • Recruitment of Subjects and Informed Consent
  • Procedures in Clinical Trials
  • Standards of a Clinical Trial site?  (Video)
  • Safety Reporting in Clinical Trials
  • The Examples of Ethical Cases
  • The Examples from Different Types of Trials

Good Clinical Practice Advanced Training Topics Planning

Planning
  • Adaptive Studies
  • The Importance of Objectivity in Clinical Trials
  • Transparency in Clinical Research
  • Endpoints in Clinical Trials
  • Open Science and Their Reflections for Clinical Research
  • Preparing a Project Application for Clinical Research Support and the Importance of Impact
  • Things to Consider When Planning a Study
  • An Example of a Clinical Trial from Design to Application
  • Configuration of the Clinical Research Question
  • Choosing the Right Statistical Evaluation Method
  • Causality Relation and Its Position in Research
  • Meaning of Statistical Inference; “p”
  • Sampling in Clinical Trials; Importance, numerical and Structural Design
  • What is the Smallest Clinical Difference? How is it detected?
  • Legal Responsibilities in Clinical Research
Workshops
  • Protocol Writing in Clinical Research
  • Examples From Different Types of Trials
  • Determinants of Method Selection for Clinical Judgement

Good Clinical Practice Advanced Training Topics Conduct

Conduct
  • Data Cleaning in Clinical Trials
  • Monitoring (Monitorization) / Auditing (Audit) / Inspection in Clinical Trials
  • Conducting Clinical Trial during the Covid-19 Outbreak
  • Clinical Trial Layout and Establishment of Data Entry
  • Variability and Summarizing Criteria in Statistics
  • Relationship Between Clinical Trial Data and Personal Data Protection Law (PDPL)
Workshops
  • Examples From Different Types of Trials
  • Which Data Should We Collect and with Which Method?
  • Simulating a Data Set in a Virtual Clinical Trial

Good Clinical Practice Advanced Training Topics Reporting

Reporting (Publication)
  • Anatomy of an Article
  • Things to be Considered when Sending an Article to the Journal?
  • How to Write a Scientific Publication?
  • How to Present Scientific Research and Publications?
  • Publication Ethics in Clinical Trials
  • A Clinical Study Example from Study Closure to Publication
  • Evaluation of the Data Set in Terms of Clinical/Statistical Significance
  • Basic Principles for Tables and Graphs to be Used in Publication
  • Conflict of Interest in Clinical Research
  • What Does the Editor Request?
  • Scientific Presentation Techniques: How to do it Face-to-face and in Virtual Platform?
  • Systematic Review and Meta-Analysis
Workshops
  • Reading the Article
  • Writing an Abstract