Diploma in ICH-GCP managed trials

Get a thorough understanding of ICH-GCP as well as the statutory and practical aspects of executing and monitoring clinical drug trials

1. Sep 2021
14. Mar 2022
5. Dec 2022

3 days course

Danish

15,340 DKK ex VAT
(app. 2,062 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

In this course you will get a thorough understanding of ICH-GCP as well as the statutory and practical aspects of executing and monitoring clinical drug trials in Denmark. The course will consist of presentations from authorities and experts in clinical trials complemented by group work and cases.

The starting point of this course is current legislation and guidelines and the different roles and responsibility of monitors and investigators/study nurses. Furthermore, focus will be on site management from the site and sponsor’s/CRO’s point of view, giving you a unique opportunity to optimize your collaboration with your partners.

To achieve a diploma you have to pass the exam of the course, which is held approximately four weeks after the course. The exam must be purchased separately. If you do not complete the exam, you will receive a Certificate of Completion.

Please note:

  • This course replaces Diploma in GCP for project nurses and Diploma in GCP for CRA/monitors

Keywords

  • Good Clinical Practice ICH-GCP 
  • National legislation
  • Audit and inspection
  • Clinical trial data handling
  • Essential documents
  • Monitoring
  • Safety reporting
  • Study drug handling
  • Site management from site and sponsor’s/CRO’s perspective
  • Collaboration with the industry
Read more

Course leader(s) & Lecturers

  • Birgitte Horst
    Course leader
    Auditor, GCP-koordinator
    GCP-Enheden
  • Mette Aamand Sørensen
    Course leader
    Principal Competency Development Specialist, DVM, PhD
    Novo Nordisk A/S
  • Lene Grejs Petersen
    Lecturer
    Chefkonsulent
    Lægemiddelstyrelsen
  • Karen Killerich
    Lecturer
    Specialkonsulent
    National Videnskabsetisk Komité
  • Birgitte Claudius
    Lecturer
    Medical Director
    AMGEN A/S
  • Mia Bekker Leimand
    Lecturer
    Databeskyttelsesrådgiver
    Region Syddanmark
  • Eva Gjerlevsen Harreskov
    Lecturer
    Clinical Trial Data Manager
    Novo Nordisk A/S
  • Heidi Filtenborg Madsen
    Lecturer
    Senior Specialist, QPPV Office
    Lundbeck A/S
  • Mai Loan Le
    Lecturer
    Afdelingschef
    NOMECO A/S
  • Lone Roslev
    Lecturer
    Clinical Trial Manager/CR
    KLIFO A/S
  • Lene Eskildsen
    Lecturer
    Head of Quality Assurance
    Vicore Pharma AB
See all

IS THIS COURSE FOR YOU?

This Diploma is basic education targeting monitors, study nurses and investigators new to role.

Site staff: 1-2 years’ experience.

Monitors: ½-1 years’ experience.

What you will learn

  1. How to comply with the ICH-GCP and other clinical trial related regulations and guidelines, when conducting and monitoring clinical trials.
  2. What the roles of the involved authorities are – and how to interact both as investigator and as sponsor
  3. How roles and responsibilities are defined for sponsor/CRO and site - and how you can optimize the collaboration between the involved partners
  4. How to collect, monitor and file clinical trial related data throughout the clinical trial
  5. The importance of timely and accurate management of safety data
  6. The importance of correct handling of study medication from packaging to destruction

What your company will get

  1. A GCP professional who knows the essence of current ICH-GCP and how to ensure compliance
  2. A GCP professional who can provide valuable input to other team members regarding ICH-GCP guidelines and relevant regulations
  3. A GCP professional who knows the principles and practical aspects of effective site monitoring
  4. An employee who knows how the importance of good collaboration with relevant stakeholders in clinical trials
  5. An employee who understands the responsibilities and duties of both investigator and sponsor

Course calendar

Choose your starting date
Starting 1. Sep 2021
Starting 14. Mar 2022
Starting 5. Dec 2022
1. Sep 2021 9:00-16:00

DAY 1

  • Basic study design
  • ICH-GCP
    • The role and responsibility of investigators
    • Investigator’s oversight (R2)
    • The role and responsibility of sponsors
  • Group work
  • Involved authorities
  1. The Danish Medicines Agency
  2. The Privacy Act
  3. The National Committee on Health Research Ethics
2. Sep 2021 9:00-16:00

DAY 2

  • Essential documents
    • Protocol
    • ICF
    • Delegation log
    • Site file - Contract + SOP contracts
    • Areas of responsibilities for site and monitor
    • Clinical trial data handling (collection)
    • Standards for trial data
    • Standards for record keeping
    • CRF
    • Source data list
  • Workshop
  • Safety reporting
    • Definitions - Standards for reporting
    • Areas of responsibilities for site and monitor
  • Handling of medicine in clinical trials
    • Distribution of roles – site vs. monitor
    • Accountability
    • Recipient control on site
    • Labeling incl. add-on labeling
    • Destruction
    • Annex 13
3. Sep 2021 9:00-16:00

DAY 3

  • Clinical trial data handling (monitoring)
    • Access to electronic patient journals
    • Risk based monitoring - SDV/SDR - Data management
  • Practical monitoring and collaboration between monitor and site
Practical information

Related exams

1. Oct 2021 10:00-13:00
Go to exam page

Registration

Registration deadline
25. Aug 2021
Atrium
Lersø Parkallé 101
2100 København Ø
Sold out
14. Mar 2022 9:00-16:00

DAY 1

  • Basic study design
  • ICH-GCP
    • The role and responsibility of investigators
    • Investigator’s oversight (R2)
    • The role and responsibility of sponsors
  • Group work
  • Involved authorities
  1. The Danish Medicines Agency
  2. The Privacy Act
  3. The National Committee on Health Research Ethics
15. Mar 2022 9:00-16:00

DAY 2

  • Essential documents
    • Protocol
    • ICF
    • Delegation log
    • Site file - Contract + SOP contracts
    • Areas of responsibilities for site and monitor
    • Clinical trial data handling (collection)
    • Standards for trial data
    • Standards for record keeping
    • CRF
    • Source data list
  • Workshop
  • Safety reporting
    • Definitions - Standards for reporting
    • Areas of responsibilities for site and monitor
  • Handling of medicine in clinical trials
    • Distribution of roles – site vs. monitor
    • Accountability
    • Recipient control on site
    • Labeling incl. add-on labeling
    • Destruction
    • Annex 13
16. Mar 2022 9:00-16:00

DAY 3

  • Clinical trial data handling (monitoring)
    • Access to electronic patient journals
    • Risk based monitoring - SDV/SDR - Data management
  • Practical monitoring and collaboration between monitor and site
Practical information

Related exams

8. Apr 2022 9:00-12:00
Go to exam page

Registration

Registration deadline
7. Mar 2022
Atrium
Lersø Parkallé 101
2100 København Ø
5. Dec 2022 9:00-16:00

DAY 1

  • Basic study design
  • ICH-GCP
    • The role and responsibility of investigators
    • Investigator’s oversight (R2)
    • The role and responsibility of sponsors
  • Group work
  • Involved authorities
  1. The Danish Medicines Agency
  2. The Privacy Act
  3. The National Committee on Health Research Ethics
6. Dec 2022 9:00-16:00

DAY 2

  • Essential documents
    • Protocol
    • ICF
    • Delegation log
    • Site file - Contract + SOP contracts
    • Areas of responsibilities for site and monitor
    • Clinical trial data handling (collection)
    • Standards for trial data
    • Standards for record keeping
    • CRF
    • Source data list
  • Workshop
  • Safety reporting
    • Definitions - Standards for reporting
    • Areas of responsibilities for site and monitor
  • Handling of medicine in clinical trials
    • Distribution of roles – site vs. monitor
    • Accountability
    • Recipient control on site
    • Labeling incl. add-on labeling
    • Destruction
    • Annex 13
7. Dec 2022 9:00-16:00

DAY 3

  • Clinical trial data handling (monitoring)
    • Access to electronic patient journals
    • Risk based monitoring - SDV/SDR - Data management
  • Practical monitoring and collaboration between monitor and site
Practical information

Related exams

6. Jan 2023 9:00-12:00
Go to exam page

Registration

Registration deadline
28. Nov 2022
Atrium
Lersø Parkallé 101
2100 København Ø
Sometimes things change. This is the expected programme.

Course information

Literature

Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

Please familiarize yourself with the mandatory readings before starting the course.

The mandatory readings are also part of the examination syllabus.

Prerequisites

Experience with contractual relations in clinical trials is an advantage, but not a requirement.

Examination

The exam is usually held 4-6 weeks after the course. It is a digital exam, and you can therefore take the exam in your own country from any location that provides adequate internet access. 

Course leader(s)

Birgitte Horst
Auditor, GCP-koordinator
GCP-Enheden
Mette Aamand Sørensen
Principal Competency Development Specialist, DVM, PhD
Novo Nordisk A/S

Lecturers

Birgitte Horst
Auditor, GCP-koordinator
GCP-Enheden
Mette Aamand Sørensen
Principal Competency Development Specialist, DVM, PhD
Novo Nordisk A/S
Lene Grejs Petersen
Chefkonsulent
Lægemiddelstyrelsen
Karen Killerich
Specialkonsulent
National Videnskabsetisk Komité
Birgitte Claudius
Medical Director
AMGEN A/S
Mia Bekker Leimand
Databeskyttelsesrådgiver
Region Syddanmark
Eva Gjerlevsen Harreskov
Clinical Trial Data Manager
Novo Nordisk A/S
Heidi Filtenborg Madsen
Senior Specialist, QPPV Office
Lundbeck A/S
Mai Loan Le
Afdelingschef
NOMECO A/S
Lone Roslev
Clinical Trial Manager/CR
KLIFO A/S
Lene Eskildsen
Head of Quality Assurance
Vicore Pharma AB

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WANT TO KNOW MORE or need help?

Contact Client Manager Christina Spangsberg at +45 39 15 09 22

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