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
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Course leader(s) & Lecturers
- Birgitte HorstCourse leaderAuditor, GCP-koordinator
GCP-Enheden - Mette Aamand SørensenCourse leaderPrincipal Competency Development Specialist, DVM, PhD
Novo Nordisk A/S
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
- How to comply with the ICH-GCP and other clinical trial related regulations and guidelines, when conducting and monitoring clinical trials.
- What the roles of the involved authorities are – and how to interact both as investigator and as sponsor
- How roles and responsibilities are defined for sponsor/CRO and site - and how you can optimize the collaboration between the involved partners
- How to collect, monitor and file clinical trial related data throughout the clinical trial
- The importance of timely and accurate management of safety data
- The importance of correct handling of study medication from packaging to destruction
What your company will get
- A GCP professional who knows the essence of current ICH-GCP and how to ensure compliance
- A GCP professional who can provide valuable input to other team members regarding ICH-GCP guidelines and relevant regulations
- A GCP professional who knows the principles and practical aspects of effective site monitoring
- An employee who knows how the importance of good collaboration with relevant stakeholders in clinical trials
- An employee who understands the responsibilities and duties of both investigator and sponsor
Course calendar
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
- The Danish Medicines Agency
- The Privacy Act
- The National Committee on Health Research Ethics
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
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
Registration
Registration deadline7. Mar 2022
Lersø Parkallé 101
2100 København Ø
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
- The Danish Medicines Agency
- The Privacy Act
- The National Committee on Health Research Ethics
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
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
Registration
Registration deadline28. Nov 2022
Lersø Parkallé 101
2100 København Ø
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)
GCP-Enheden
Novo Nordisk A/S
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