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ICH GCP Interactive in English | Good Clinical Practice Training Course

The International Good Clinical Practice online training course is fully ICH-GCP compliant and allows you to participate in international clinical trials. Updated Nov 2016.

This Good Clinical Practice (GCP) course is a comprehensive guide to ICH-GCP principles and their practical application in the workplace. You will learn how to apply them in your work on a daily basis. The course provides case scenarios, taken from real life examples encountered by author, Nick Deaney; who has 30 years' experience up to Research Director level in a major pharma group. This GCP course is essential for those new to clinical research or experienced staff from the NHS, University Hospitals, Pharma, CROs and research institutes, investigators, clinical trials support staff, research nurses and ethics committee members. Updated with ICH E6 (R2) in Nov 2016.

  • Average study time:
    study time

    9 hrs

  • Personal development points (CPD):
    points

    9 points

  • Price:
    points

    £79.00

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Course Details

ICH GCP Interactive in English online course details:

  • Interactive with a clear, attractive format.
  • You can solve problems as you work through the course to reinforce your learning.
  • Easily cross reference to the ICH-GCP E6 document.
  • Multiple choice questions throughout the course prepare you for the exam.
  • Gain useful insights into the application of GCP from the author's vast experience.
  • Carries 9 CPD points and accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom.

Benefits for you

  • CPD Points - Gain Continuing Professional Development (CPD) Points that are accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
  • Certification - Receive a personal certificate to show your subject knowledge on course completion.
  • Affordable - You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
  • Flexible - The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
  • Up to Date - You will stay up to date with any legislative changes in GCP as our training courses are constantly monitored, reviewed and updated.
  • Learn from Industry Experts - The course content has been developed to ensure that you comply with ICH-GCP regulations through the application of learning outcomes. The course provides case scenarios, taken from real life examples encountered by author, Nick Deaney; who has 30 years' experience up to Research Director level in a major pharma group.

Course Syllabus

Chapter 1: Introduction to GCP

1.1 Background
1.2 What is GCP?
1.3 Why should we have ICH-GCP? (Case Scenario)
1.4 The Principles of ICH GCP
1.5 Some General Points
1.6 Documentation and Version Control
1.7 Quality Assurance
1.8 Other Resources

Chapter 2: Competent Authorities (CA) and Independent Ethics Committee (IEC)

2.1 About this Chapter
2.2 Introduction
2.3 Responsibilities of the CA
2.4 Responsibility of the IEC
2.5 Subject Informed Consent Forms (ICF) I
2.6 Subject Informed Consent Forms (ICF) II
2.7 Subject Informed Consent Forms (ICF) III (Case Scenario)
2.8 Composition, Functions, Operations, Procedures and Records
2.9 IEC interactions with Sponsors and Investigators

Chapter 3: Investigator

3.1 About this Chapter
3.2 Introduction
3.3 Investigator Responsibilities
3.4 Investigator Qualifications and Agreements I
3.5 Investigator Qualifications and Agreements II (Case Scenario)
3.6 Adequate Resources I
3.7 Adequate Resources II (Case Scenario)
3.8 Adequate Resources III (Case Scenario)
3.9 Medical Care of Trial Subjects I
3.10 Medical Care of Trial Subjects II (Case Scenario)
3.11 Medical Care of Trial Subjects III (Case Scenario)
3.12 Medical Care of Trial Subjects IV (Case Scenario)
3.13 Communication with IRB/IEC I
3.14 Communication with IRB/IEC II (Case Scenario)
3.15 Communication with IRB/IEC III (Case Scenario)
3.16 Communication with IRB/IEC IV (Case Scenario)
3.17 Communication with IRB/IEC V (Case Scenario)
3.18 Compliance with the Protocol I
3.19 Compliance with the Protocol II (Case Scenario)
3.20 Compliance with the Protocol III (Case Scenario)
3.21 Compliance with the Protocol IV (Case Scenario)
3.22 Investigational Medicinal Product I (Case Scenario)
3.23 Investigational Medicinal Product II (Case Scenario)
3.24 Investigational Medicinal Product III (Case Scenario)
3.25 Investigational Medicinal Product IV (Case Scenario)
3.26 Randomization Procedures and Un-blinding I
3.27 Randomisation Procedures (Case Scenario)
3.28 Informed Consent of Trial Subjects I
3.29 Informed Consent of Trial Subjects II (Case Scenario)
3.30 Informed Consent of Trial Subjects III (Case Scenario)
3.31 Informed Consent of Trial Subjects IV
3.32 Notification/ Submission to Regulatory Authorities IV (Case Scenario)
3.33 Informed Consent of Trial Subjects VI (Case Scenario)
3.34 Informed Consent of Trial Subjects VII (Case Scenario)
3.35 Informed Consent of Trial Subjects VIII
3.36 Informed Consent of Trial Subjects IX
3.37 Informed Consent of Trial Subjects X (Case Scenario)
3.38 Informed Consent of Trial Subjects XI
3.39 Informed Consent of Trial Subjects XII (Case Scenario)
3.40 Informed Consent of Trial Subjects XIII
3.41 Informed Consent of Trial Subjects XIV (Case Scenario)
3.42 Records and Reports I
3.43 Records and Reports II
3.44 Records and Reports III
3.45 Records and Reports IV
3.46 Records and Reports V (Case Scenario)
3.47 Records and Reports VI (Case Scenario)
3.48 Records and Reports VII
3.49 Records and Reports VIII (Case Scenario)
3.50 Records and Reports IX
3.51 Records and Reports X
3.52 Records and Reports XI (Case Scenario)
3.53 Records and Reports XII (Case Scenario)
3.54 Premature Termination or Suspension of a Trial I
3.55 Progress Reports and Final Report(s) by Investigator
3.56 Archiving

Chapter 4: Sponsor's Responsibilities

4.1 About this Chapter
4.2 Introduction
4.3 Quality Assurance and Quality Control I
4.4 Quality Assurance and Quality Control II (Case Scenario)
4.5 Quality Assurance and Quality Control III
4.6 Quality Assurance and Quality Control IV (Case Scenario)
4.7 Quality Assurance and Quality Control V
4.8 Quality Assurance and Quality Control VI (Case Scenario)
4.9 Contract Research Organisations I (Case Scenario)
4.10 Contract Research Organisations II (Case Scenario)
4.11 Medical Expertise I (Case Scenario)
4.12 Trial Design I
4.13 Trial Management, Data Handling and Record Keeping I
4.14 Trial Management, Data Handling and Record Keeping II (Case Scenario)
4.15 Trial Management, Data Handling and Record Keeping III
4.16 Trial Management, Data Handling and Record Keeping IV (Case Scenario)
4.17 Trial Management, Data Handling and Record Keeping V
4.18 Trial Management, Data Handling and Record Keeping VI (Case Scenario)
4.19 Trial Management, Data Handling and Record Keeping VII
4.20 Trial Management, Data Handling and Record Keeping VIII (Case Scenario)
4.21 Investigator Selection I
4.22 Investigator Selection II (Case Scenario)
4.23 Investigator Selection III (Case Scenario)
4.24 Investigator Selection IV (Case Scenario)
4.25 Investigator Selection VI
4.26 Investigator Selection VI (Case Scenario)
4.27 Investigator Selection VII
4.28 Investigator Selection VIII
4.29 Investigator Selection IX (Case Scenario)
4.30 Financing I
4.31 Notification/ Submission to Regulatory Authorities I
4.32 Gaining CA approval in the EU
4.33 Notification/ Submission to Regulatory Authorities II (Case Scenario)
4.34 Notification/ Submission to Regulatory Authorities III (Case Scenario)
4.35 Notification/ Submission to Regulatory Authorities IV (Case Scenario)
4.36 Confirmation of Review by IRB/IEC I
4.37 Confirmation of Review by IRB/IEC II (Case Scenario)
4.38 Information on IMP I (Case Scenario)
4.39 Manufacturing, Packaging, Labelling and Coding Investigational Products I
4.40 Manufacturing, Packaging, Labelling and Coding Investigational Products II (Case Scenario)
4.41 Manufacturing, Packaging, Labelling and Coding Investigational Products III (Case Scenario)
4.42 Manufacturing, Packaging, Labelling and Coding Investigational Products IV (Case Scenario)
4.43 Supplying and Handling Investigational Products I
4.44 Supplying and Handling Investigational Products II (Case Scenario)
4.45 Supplying and Handling Investigational Products III (Case Scenario)
4.46 Record Access I (Case Scenario)
4.47 Audit and Inspection I (Case Scenario)
4.48 Noncompliance I
4.49 Premature Termination or Suspension of a Trial
4.50 Clinical Trial/Study Reports
4.51 Multicentre Trials

Chapter 5: Monitor's Responsibilities

5.1 About this Chapter
5.2 Introduction
5.3 Monitoring II (Case Scenario)
5.4 Monitoring III
5.5 Monitoring IV (Case Scenario)
5.6 Monitoring V (Case Scenario)
5.7 Monitoring VI (Case Scenario)
5.8 Monitoring VII
5.9 Monitoring VIII (Case Scenario)
5.10 Monitoring IX (Case Scenario)
5.11 Monitoring X (Case Scenario)
5.12 Monitoring XI
5.13 Monitoring XII (Case Scenario)
5.14 Monitoring XIII (Case Scenario)
5.15 Monitoring XIV
5.16 Monitoring XV - Verifying Subject Data
5.17 Monitoring XVI (Case Scenario)
5.18 Monitoring XVII
5.19 Monitoring XVIII (Case Scenario)
5.20 Monitoring XIX (Case Scenario)
5.21 Monitoring XX

Chapter 6: Safety & Adverse Event Reporting

6.1 About this Chapter
6.2 Introduction
6.3 Adverse Drug Reaction Reporting I
6.4 Adverse Drug Reaction Reporting II (Case Scenario)
6.5 Adverse Drug Reaction Reporting III
6.6 Adverse Drug Reaction Reporting IV (Case Scenario)
6.7 Adverse Drug Reaction Reporting V (Case Scenario)
6.8 Adverse Drug Reaction Reporting VI
6.9 Adverse Drug Reaction Reporting VII (Case Scenario)
6.10 Adverse Drug Reaction Reporting VIII
6.11 Adverse Drug Reaction Reporting IX
6.12 Adverse Drug Reaction Reporting X

Chapter 7: Clinical Trial Protocol and Amendments

7.1 About this Chapter
7.2 Writing a Protocol (Case Scenario)
7.3 Protocol Content I
7.4 Protocol Content II (Case Scenario)

Chapter 8: Investigator Brochure

8.1 About this Chapter
8.2 Managing an Investigator Brochure (Case Scenario)
8.3 Table of Contents of Investigator Brochure (Example)

Chapter 9: Essential Documents

9.1 About this Chapter
9.2 Essential Documents (Case Scenario)
9.3 Archiving
9.4 Archiving II (Case Scenario)
9.5 Documents to be present Pre-Study (Case Scenario)
9.6 Documents to be Added During the Study (Case Scenario)
9.7 Documents to be Added Post-Study (Case Scenario)

Glossary

Useful Documents

Links

Exam (30 questions selected from a database)

 

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