This basic GCP training for Investigators is based on the requirements of the German Medical Association(Bundesaerztekammer) and the Working Group of Medical Ethic Committees.
Additionally, the training offered meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
To ensure the safety and well-being of subjects and patients at all times, clinical trials need to be carried out to the highest quality standards and in accordance with national and international guidelines. This seminar equips prospective Clinical Investigators with the necessary skills and knowledge for conducting clinical trials, based on a sound understanding of Good Clinical Practice (GCP), the legal framework, ethical considerations, and the roles and responsibilities of all parties involved in a trial.
- Applicable national and drug laws and related international guidelines
- Responsibilities of the Investigator
- Essential documents in a clinical trial
- Approval process of Ethic Committees and Regulatory Authorities
- Study drug and test articles
- Documentation for a clinical trial
- Safety reporting
- Quality assurance
- qualified and practicing physicians wishing to work in clinical research
- physicians who have not yet conducted a clinical trial as an investigator, deputy or study team physician (in line with AMG §4 para. 25 und §40 para.1a)
- investigators who want to re-new their GCP certificate
On completion of this seminar, you will have a sound grasp of Good Clinical Practice and a thorough understanding of the regulatory framework governing the conduct of clinical trials today. You will be familiar with the procedures for setting up a trial, the requirements for participation, and know exactly what happens at the regular visits, audits and inspections.
The contents of this seminar comply with Ethic Committees requirements concerning the training of clinical trial investigators. The GCP certificate, which you obtain on successful completion of this course, is recognized by all German Ethic Committees for participation in clinical trials.
The one-day, compact GCP training for Investigators comprises 9 lessons (each lesson lasts 45 minutes) and includes a written assessment. This course is certified by the Medical Association Berlin ("Aerztekammer"), (category A, 9 points).
- Aims of clinical trials
- Phases of clinical and epidemiological studies
- Study design and types of studies
- Definition of clinical studies in contrast to non-interventional studies
- Basic understanding of biostatistics
International Ethical Principles and Guidelines
- Historical perspective: milestones in Clinical Research
- International Guidelines and standards
- Declaration of Helsinki
- International Conference on Harmonization - Good Clinical Practice Guideline (ICH-GCP)
International guidelines and national laws
- EU directives
- National laws
Preparation of a clinical trial
- Essential documents
- Approval process of the Ethics Committee and Regulatory Authority
- Notification of the Local Regulatory Authority
Conduct of a clinical trial
- Site selection process
- Patient recruitment
- Safety Reporting
- Study Drug
- Quality Assurance
- Visit Overview