Uitgelicht en gespot op internet (week 17, 2023)

Hierbij een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘, met een overzicht van nieuws en andere berichten die zijn gespot op het internet.

Met vriendelijke groet,

Vincent Bontrop

U kunt met mij linken via LinkedIn.

Belgian Association of Research Ethics Committees (BAREC)

Clinical Trials Coordination Group (CTCG)

CTCG’s developed a Simplified template of Annual Safety Report, April 2023. Non-commercial sponsors conducting a single clinical trial on IMPs with a MAH in any of the EU/EEA member states and where the SmPC is used as RSI submitting this simplified ASR based on the ICH-E2F may be appropriate. This template gives detailed instructions on what information is expected and what may be omitted in this setting. The simplified ASR should always be written in English.

bron: CTCG Key documents list

Clinical Trial Regulation (CTR), Clinical Trials Information System (CTIS)

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Clinical trials

Council for International Organizations of Medical Sciences (CIOMS)

… The objective of the meeting was to present the results of a recently published scoping review on the considerations of sex and gender dimensions by research ethics committees and to initiate a discussion on the role of research ethics committees (RECs) and research ethics guidelines in addressing the gender bias in research.”

bron: Lembit Rägo, via LinkedIn (27-04-2023).

Dierexperimenteel onderzoek

EQUATOR network (Enhancing the QUAlity and Transparency Of health Research)

  • EQUATOR Network Newsletter April 2023 (27-04-2023).
    • Sharing opportunities for patients to influence methodology research
    • The EQUATOR Network reporting guideline database audit has been published
    • Biomedical research data sharing and management: The Ottawa Data Champions project
    • UK EQUATOR Centre contributes to the HRA Make It Public week
    • Journals update guidelines after review highlights incomplete reporting of interventions
    • Contacting trial authors may improve the often poor description of interventions in COVID studies
    • Poor methodology and reporting of prediction models developed using machine learning in oncology
    • Guidance for reporting studies using artificial intelligence natural language models is now under development

European Medicines Agency (EMA)

“EMA intends to gradually resume clinical data publication from September 2023, having temporarily suspended this activity for all products except Treatments and vaccines for COVID-19.”

bron: EMA website ‘Support for industry on clinical data publication’

EU’s pharmaceutical legislation

Global Alliance for Genomics and Health (GA4HA)

Medische hulpmiddelen, Clinical investigation, clinical study, or a clinical trial 

Medische hulpmiddelen, Orphan Drug/Device Criteria across the US, Japan, Australia, EU and Brazil markets

Nieuwsbrief voor Goede Onderzoekspraktijken



Stichting Code Geneesmiddelen Reclame (CGR)

US Food and Drug Administration’s (FDA)


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