Applied good clinical practice

Performance of clinical trials according to Good Clinical Practice (GCP) principles has been introduced as a European regulatory requirement by the Clinical Trial Directive 2001/20/EC and is also now the basis for the EU Clinical Trial Regulations 536/2014. Strict adherence to this standard ensures patient protection and reliable data. It is the basis for acceptance of publications and for patients’ access to new treatments. This standard has implications for all stakeholders and processes in clinical trials. However, despite overall commitment and best intentions to apply to these requirements, monitoring, audits and inspections regularly find deficiencies of different levels of severity.

In this interactive workshop current experience and requirements of GCP-conform set-up and performance of clinical trials will be presented, their practical implications and examples discussed and pragmatic solutions for daily practice elaborated.

Topics included are:

• Good Clinical Practice in European and Belgian legislation
• Set-up of the clinical trial at the investigator site
• Optimising the informed consent process
• GCP compliance in document management
• Critical elements in conducting clinical trials
• Reliable safety management at the site

Learning outcomes

At the end of the course, you are able to:

• understand the principles and content of the GCP standard,
• comprehend the duties and complexities of organizing a clinical trial at the investigator site, roles and responsibilities of the team members,
• understand the relevance, content and processes of informed consent,
• know the clinical trial documentation, filing and archiving obligations of the Principal Investigator and his/her staff,
• understand the key aspects of clinical trial management and quality assurance in clinical trials,
• comprehend the basic elements of safety data collection and assessment.

Participants who succesfully complete the test at the end will receive a "EFGCP GCP Certificate of Completion"

Competences

An important part of preparing for any further professional step is becoming (more) aware of the competences you have developed and/or want to develop. In the current workshop, the following competences from the UHasselt competency overview are actively dealt with:

• intellectual competences
  
  • critical judgement
  • risk management
• personal effectiveness
  • ethics & integrity
  • responsibility
• task-orientedness
  
  • quality assurance
• interpersonal competences
  • interdisciplinary collaboration

For whom?

• PhD students and postdocs of the Doctoral School of Health & Life Sciences
• max. 120 participants

When and where?

• May 09, 2022 - 09:00-16:00
• This course will be organized online

Registration?

• Registration is now closed.
• As places are limited, registering does not automatically imply that you will be able to participate. You will be notified by email in due time.
• Please cancel your registration at least one week in advance in case you cannot make it (cf. cancellation & no-show policy).

Acknowledged as?

• DS HLS: category 'scientific skills' - one compulsory elective course