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Clinical Practice
Pharmacovigilance
Manufacturing
Laboratory Practice
Distribution
MDR

About

Dieser GCP-Kurs vermittelt die aktuellen Anforderungen der internationalen ICH-GCP-Richtlinie E6(R3), ergänzt um nationale Vorgaben für klinische Studien in Deutschland. Der Fokus liegt auf Investigator Oversight, patientenzentrierten Studiendesigns, dem risikobasierten Qualitätsmanagement und dem Einsatz digitaler Technologien – zentralen Neuerungen der R3-Version. Basierend auf mehr als zwei Jahrzehnten praktischer Erfahrung im pharmazeutischen Umfeld bietet dieser Kurs verständliche, anwendungsorientierte Inhalte für Prüfer, Studienpersonal, Monitore und Sponsorenvertreter. Nach Abschluss erfüllt der Teilnehmer alle regulatorisch geforderten Schulungsanforderungen für die Mitarbeit in internationalen klinischen Prüfungen nach E6(R3).

Course Syllabus

  1. Was ist GCP und warum ist sie notwendig?
  2. Historische Entwicklung (Nürnberger Kodex, Deklaration von Helsinki)
  3. Gründung der ICH und Einführung der ICH-GCP
  4. Überblick zu E6(R1), E6(R2) und E6(R3)
  5. Die 13 Grundprinzipien der GCP (inkl. Neuerungen in E6[R3])
  6. Relevante Begriffe und Terminologie
  7. Quizfragen zur Wiederholung

  1. Rolle und Aufgaben der Ethikkommission (EK)
  2. Bundesoberbehörden in Deutschland: BfArM & PEI
  3. Neuer Genehmigungsprozess nach EU-CTR (Part I & II via CTIS)
  4. Ablauf & Fristen im CTIS-System
  5. Bedeutung des Ethikvotums für Prüfärzte
  6. Zusammenfassung & Quizz zum Genehmigungsverfahren

  1. Gesetzliche Grundlagen für Prüfer (AMG, GCP-V, E6[R3])
  2. Investigator Oversight: Aufgaben, Delegation, Kontrolle
  3. Ressourcen, Infrastruktur und Dokumentation
  4. Schulung & Qualifikation des Personals
  5. Praktische Maßnahmen & häufige Herausforderungen
  6. Dokumentationsanforderungen & Nachweise
  7. Quizz zur Rolle des Prüfers

  1. Grundsätze der Aufklärung und Einwilligung
  2. Rolle des Prüfers im ICF-Prozess
  3. Besondere Patientengruppen: Minderjährige, urteilsunfähige Personen, Notfälle
  4. Digitale Einwilligung (eConsent): Anforderungen & Praxisbeispiele
  5. Dokumentationspflichten und Umgang mit neuen ICF-Versionen
  6. Quizz: Einwilligung in verschiedenen Szenarien

  1. Gesetzliche Anforderungen zur Protokolltreue
  2. Umgang mit Abweichungen (Deviations vs. Violations)
  3. Verantwortung und Meldepflichten des Prüfers
  4. Investigator Oversight bei Abweichungen
  5. Quizz: Protokolländerungen & GCP-Konformität

  1. Anforderungen an Studiendaten gemäß E6(R3)
  2. eSource, Audit Trails & elektronische Systeme
  3. Datensicherheit & Zugriffskontrolle
  4. Archivierungspflichten & ISF
  5. Datenschutz & Patientenvertraulichkeit
  6. Quizz zur Datenqualität & Nachvollziehbarkeit

  1. Schwerwiegende unerwünschte Ereignisse (SAEs)
  2. SUSAR-Meldungen: Anforderungen & Fristen
  3. Verantwortung von Prüfer & Sponsor
  4. Umgang mit Sicherheitsinformationen & Re-Consent
  5. Quizz: AE vs. SAE vs. SUSAR

  1. Übersicht wichtiger Behörden & Quellen (EMA, FDA, ICH, BfArM, PEI)
  2. Zusammenfassung der Prüferpflichten nach E6(R3)
  3. Empfehlungen zur weiteren Vertiefung

Course Certificate

On course completion, you receive your official ICH-GCP e6(R3) certification, allowing you to participate in clinical trials internationally
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Our GCP certified customers

novartis
NHS
takeda
roche
baxter

Learner Rating & Reviews

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Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

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Frequently Asked Questions

Good Clinical Practice (GCP) training is a vital educational programme designed to arm clinical trial professionals and researchers with essential knowledge about ethical and scientific standards. These standards are crucial for executing high-quality clinical trials. The training encompasses the globally recognised guidelines set forth by the International Council for Harmonisation (ICH).

The key objectives of GCP training include:

  • Safeguarding the rights, safety, and welfare of human participants
  • Upholding the accuracy and reliability of data collected during clinical trials
  • Fostering uniform, top-tier practices across all facets of clinical research

The Whitehall Training Good Clinical Practice Course thoroughly explores these critical areas, offering learners a robust grounding in both the theoretical principles and practical applications of Good Clinical Practice.

For those involved in clinical trials research, obtaining GCP certification is essential.

If you're keen to broaden your knowledge of the field, GCP certification offers significant benefits, including:

  • Alignment with global regulatory requirements
  • Bolstering the integrity and standard of research
  • Safeguarding the rights and well-being of study participants
  • Expanding career opportunities within clinical research

Our Whitehall Training Good Clinical Practice Course not only results in certification but also imparts practical knowledge for effectively implementing GCP principles in your day-to-day work.

Good Clinical Practice (GCP) certification is crucial for numerous roles within the field of clinical research:

  • Lead and Co-Investigators: Those who bear primary responsibility for conducting trials at research locations.
  • Research Support Teams: This includes study coordinators, clinical research nurses, and other on-site personnel integral to trial operations.
  • Trial Sponsors and Research Organisations: Individuals overseeing the planning, commencement, and documentation of clinical studies.
  • Oversight Bodies: Officials tasked with monitoring and assessing trial compliance with regulations.
  • Ethics Committees and Review Boards: Members involved in the evaluation and approval of trial protocols.
  • University and Research Centre Staff: Those ensuring that institutional research aligns with global standards.
  • Researchers Funded by National Bodies: All staff and investigators participating in nationally funded clinical trials.

The Whitehall Training Good Clinical Practice Course is designed to meet the needs of this broad spectrum of professionals, offering both general GCP principles and role-specific guidance.

Additionally, our course proves beneficial for individuals aiming to enhance their research capabilities and refine their clinical trial management skills.

Our Good Clinical Practice (GCP) course thoroughly covers the ICH-GCP (E6-R2) international guidelines, ensuring you meet the training requirements for participation in global clinical trials. We offer this comprehensive training in multiple languages to cater to a diverse audience.

This course serves as a contemporary, step-by-step guide to the ICH-GCP (E6-R2) guidelines, making it an indispensable resource for anyone involved in clinical trial management. The content has been meticulously crafted by an industry veteran with over three decades of experience, including a tenure as Research Director at a prominent pharmaceutical company.

We're proud to have received accreditation from the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom, underscoring the quality and relevance of our course material. To accommodate our international learners, we've made the course available in ten languages, including English, German, Bulgarian, French, Italian, Japanese, Polish, Portuguese, Russian and Spanish.

Understanding the importance of regional regulatory frameworks, we've developed tailored versions of this course for Australia, the UK, the US, France, Germany and Latin America. These localised editions ensure that participants receive training that's directly applicable to their specific regulatory environment.

Our course boasts a user-friendly, visually engaging format that facilitates easy cross-referencing with the ICH-GCP E6 document. Drawing from the author's extensive practical experience, it offers valuable insights into the real-world application of GCP principles. As an added benefit, participants can earn 6 CPD points upon successful completion of the course.

Indeed, our GCP course has received certification from a prestigious body. The Faculty of Pharmaceutical Medicine at the Royal College of Physicians has given their seal of approval to our programme. This organisation is well-regarded as the professional membership body for pharmaceutical physicians in the United Kingdom and has been establishing stringent research standards since 1989.

The certification from such a respected institution demonstrates that our course meets exacting industry and academic criteria. As a result, when you complete our GCP course, you'll receive a qualification that is widely acknowledged and valued within the field.

Several factors influence the cost of GCP training:

  • Official endorsements: Has the course received approval from recognised bodies?
  • International compliance: Does the training fulfil ICH standards, allowing participation in global clinical studies?
  • Content relevance: Is the material current and authored by industry professionals?
  • Duration of availability: For how long can students access the course materials?

At £79, our Whitehall Training GCP course offers excellent value due to:

  • Endorsement: The Royal College of Physicians has accredited the course, awarding 6 CPD points.
  • Global acceptance: Our training adheres to ICH E6(R2) guidelines, enabling involvement in international clinical trials.
  • Expert-crafted content: Lucy Parker, our GCP specialist with over 10 years' experience leading research in major institutions like the NHS, has developed the course material.
  • Ongoing access: We support continuous professional development by providing unlimited access to course resources.

For group bookings, we offer a 10% discount on purchases of 5 licences at checkout. If you're interested in larger group discounts, please contact our team for a tailored quote.