ICH GCP R3 is now in English & EU languages. Book Now

About

Written by an expert with over 30 years of experience up to the Research Director level in a major pharma group, this GCP training course covers the ICH-GCP (E6-R3) international guidelines and meets the training requirement for you to participate in international clinical trials.

Course Syllabus

  1. GCP的历史:第一部分
  2. GCP发展史:第二部分
  3. GCP发展史:第三部分
  4. GCP发展史:第四部分
  5. GCP是什么?
  6. ICH GCP原则:第一部分
  7. ICH GCP原则:第二部分
  8. 补充学习要点
  9. 文档和版本控制
  10. 质量保证(QA)
  11. 关键资源:第一部分
  12. 关键资源:第二部分

  1. 引言:第一部分
  2. 引言:第二部分
  3. 引言:第三部分
  4. 引言:第四部分
  5. 引言:第五部分
  6. 引言:第六部分
  7. 引言:第七部分
  8. 引言:第八部分
  9. 引言:第九部分
  10. 监管机构的职责
  11. 国际电工委员会的职责
  12. 受试者知情同意书(ICF)第 1 部分
  13. 受试者知情同意书(ICF):第二部分
  14. 组成、功能、操作、程序和记录
  15. IEC与申办方和研究者的互动

  1. 介绍
  2. 调查员职责
  3. 调查员资质和协议
  4. 充足的资源
  5. 试验受试者的医疗保健:第一部分
  6. 试验受试者的医疗保健:第二部分
  7. 与伦理委员会/独立伦理委员会的沟通
  8. 遵守协议
  9. 研究性药品
  10. 随机化程序和揭盲
  11. 知情同意:引言
  12. 知情同意:同意讨论
  13. 知情同意:不识字或不会写字的受试者
  14. 知情同意:未成年人和“精神不健全”受试者
  15. 知情同意:无行为能力者
  16. 知情同意:更新同意
  17. 记录和报告:简介
  18. 记录和报告:研究地点档案
  19. 记录和报告:更新和修订
  20. 记录和报告:原始文件
  21. 记录和报告:财务信息
  22. 记录和报告:病例记录表
  23. 记录和报告:记录主体数据
  24. 审判提前终止或中止
  25. 调查员的进度报告和最终报告
  26. 调查员职责

  1. 引言:第一部分
  2. 引言:第二部分
  3. 引言:第三部分
  4. 质量管理:第一部分
  5. 质量管理:第二部分
  6. 质量管理第三部分
  7. 质量保证与质量控制(QA和QC):简介
  8. 质量保证和质量控制(QA and QC):标准操作程序
  9. 质量保证与质量控制:协议与合同
  10. 合同研究组织
  11. 试验设计
  12. 试验管理:简介
  13. 试验管理:数据管理
  14. 试验管理:电子数据
  15. 庭审管理:记录保存
  16. 研究者遴选:引言
  17. 调查员选择:权限
  18. 调查员遴选:职责
  19. 调查员遴选:报酬
  20. 融资
  21. 向监管机构提交/通知
  22. 伦理审查委员会/独立伦理委员会的审查确认
  23. IMP 信息
  24. 研究用药品的生产、包装、标签和编码:第 1 部分
  25. 研究用药品的生产、包装、标签和编码:第二部分
  26. 供应和处理研究用产品
  27. 记录访问
  28. 数据处理 I
  29. 数据处理 II
  30. 数据处理 III
  31. 数据处理 IV
  32. 数据处理 V
  33. 数据处理 VI
  34. 统计编程与数据分析 I
  35. 统计编程与数据分析 II
  36. 记录保存与留存
  37. 审计和检查
  38. 不合规
  39. 审判的提前终止或中止:第一部分
  40. 审判的提前终止或中止:第二部分
  41. 临床试验/研究报告
  42. 多中心试验

  1. 介绍
  2. 数据治理(第一部分
  3. 数据治理(第二部分
  4. 维护盲人
  5. 数据生命周期 I
  6. 数据生命周期 II
  7. 数据生命周期 III
  8. 数据生命周期 IV
  9. 计算机系统 I
  10. 计算机系统 II
  11. 计算机系统 III
  12. 计算机系统 IV
  13. 计算机系统 V
  14. 计算机化系统 VI
  15. 计算机系统 VII

  1. 介绍
  2. 监视器
  3. 监测访问:第一部分
  4. 监测访问:第二部分
  5. 验证 IMP
  6. 遵守规程、修正案、标准操作规程和指南
  7. 核实知情同意
  8. 病例记录表(CRF)和原始文件
  9. 核实受试者数据
  10. 监测访问结束
  11. 监测报告和计划
  12. 质量管理 - 集中监控
  13. 欺诈和不当行为:第一部分
  14. 欺诈和不当行为:第二部分

  1. 介绍
  2. 不良事件、不良反应和可疑不明原因不良事件
  3. 严重不良事件
  4. 严重不良事件
  5. 特别关注的不良事件
  6. 定期安全性报告

  1. 介绍
  2. 协议结构与内容:第一部分
  3. 协议结构与内容:第二部分
  4. 协议结构与内容:第三部分

  1. 介绍
  2. 调查员手册结构和内容

  1. 引言
  2. 归档
  3. 入学前需提交的文件
  4. 入学后需提交的文件

  1. 词汇表和缩写
  2. 欧盟指导文件
  3. ICH 指导文件
  4. 美国 FDA 指导文件
  5. GCP 课程讲义
  6. 全球主管机构名单

Our GCP certified customers

novartis
NHS
takeda
roche
baxter

Learner Rating & Reviews

4.7
Average Rating
536 global ratings
87.0%
5.0%
3.0%
3.0%
2.0%
RC

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...

SM

I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...

Frequently Asked Questions

Good Clinical Practice (GCP) training is an essential educational program that equips researchers and clinical trial professionals with the knowledge of ethical and scientific standards crucial for conducting high-quality clinical trials. This comprehensive training covers the internationally recognized guidelines established by the International Council for Harmonisation (ICH).

The primary goals of GCP training are:

  1. Ensuring the protection of human subjects' rights, safety, and well-being
  2. Maintaining the integrity and reliability of clinical trial data
  3. Promoting consistent, high-quality practices across all aspects of clinical research

Our GCP course delves into these critical areas, providing learners with a solid foundation in the principles and practical applications of Good Clinical Practice.

For researchers interested in participating in clinical trials, GCP certification is a necessity.

For those who are simply interested in improving their understanding of the field, GCP certification is highly valuable due to its:

  1. Ensures compliance with international standards
  2. Enhances research credibility and quality
  3. Protects participant rights and safety
  4. Improves career prospects in clinical research

Our course not only provides certification but also equips you with practical skills to apply GCP principles effectively in your work.

GCP certification is essential for a wide range of professionals in clinical research:

  1. Clinical Trial Investigators: Principal investigators and sub-investigators responsible for trial conduct at research sites.
  2. Clinical Trial Staff: Including research coordinators, study nurses, and other site personnel involved in trial management.
  3. Sponsors and Contract Research Organizations (CROs): Those overseeing trial planning, initiation, and reporting.
  4. Regulatory Authorities: Officials who monitor and evaluate trial compliance.
  5. Institutional Review Boards (IRBs) and Ethics Committees: Members reviewing and approving trial protocols.
  6. Academic and Research Institution Staff: Ensuring adherence to international standards in institutional research.
  7. NIH-Funded Researchers: All investigators and staff involved in NIH-funded clinical trials.

Our course caters to this diverse audience, providing role-specific insights alongside core GCP principles. The course is also valuable for anyone looking to upskill their research abilities and improve their clinical trials operations.

This GCP training course covers the ICH-GCP (E6-R3) international guidelines and meets the training requirement for you to participate in international clinical trials. Multiple language versions are available. This GCP training course is a step-by-step and up-to-date guide to the international ICH-GCP (E6-R3) guidelines. It is essential for anyone taking part in the running of a clinical trial.

The course was written by an expert with over 30 years of experience up to the Research Director level in a major pharma group. Our ICH GCP training is accepted worldwide as it meets the TransCelerate Biopharma mutual recognition criteria. Also, it is accredited by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. Apart from English, the course is available in German, Bulgarian, French, Italian, Japanese, Polish, Portuguese, Russian and Spanish. We also produce regional versions of this course tailored to the specific regulatory frameworks in Australia, the UK, the US, France, Germany and Latin America.

This course features a clear and visually appealing format, allowing for easy cross-referencing to the ICH-GCP E6 document. It offers valuable insights into the practical application of Good Clinical Practice (GCP) based on the author's extensive experience. Furthermore, it is accredited by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom and provides participants with the opportunity to earn 6 CPD points.

Yes, our GCP course is accredited by two industry-leading organisations:

  1. TransCelerate Biopharma Inc.: A nonprofit organisation collaborating with 20 major pharmaceutical companies. Their mutual recognition program is considered the gold standard in the field of clinical practice.
  2. The Faculty of Pharmaceutical Medicine at the Royal College of Physicians: The professional membership body for pharmaceutical physicians in the UK, known for setting rigorous standards for research since 1989.

These accreditations ensure our course meets the highest industry and academic standards, offering you a widely recognized certification.

Costs vary depending on the following factors:

  • Accreditation: Is the course approved by official organisations, like TransCelerate?)
  • Certification: Does the course meet the ICH requirements that allows researchers to participate in international clinical trials?
  • Quality of content: Is the course up-to-date, and written by an expert?
  • Access: How long are learners able to access the course?

Whitehall Training’s GCP course is £79 due to its:

  • Accreditation: It is TransCelerate approved, and accredited by the Royal College of Physicians with 6 CPD points.
  • Certification: The course enables users to participate in clinical trials, following the ICH E6(R3) guidelines.
  • Quality of content: Our course is written by our Good Clinical Practice expert, Lucy Parker, who has over a decade of experience directing research across large research institutes such as the NHS.
  • Access: To support the lifelong learning of our researchers, we provide lifetime access to our course resources.

Buying for a team? We offer 10% off orders of 5 licences at checkout. For discounts on larger orders, please get in touch with our team.