Uitgelicht en gespot op internet (week 47, 2022)

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.

Vergeet niet om ook regelmatig een kijkje te nemen op de Consultations-pagina (consultations.bontrop.com) en de Events-pagina (events.bontrop.com).

Met vriendelijke groet,

Vincent Bontrop

U kunt met mij linken via LinkedIn en Mastodon.

Accelerating Clinical Trials in the EU (ACT EU)

Algemene verordening gegevensbescherming (AVG), Data Privacy Impact Assessment (DPIA)

Centrale Commissie Dierproeven (CCD)

Clinical trials

Clinical Trials Regulation (CTR)

Clinical trials results reporting

As of June 2022, 81% of clinical trials are compliant with this requirement in EudraCT.

Between April 2019 and June 2022, the compliance rate rose:

  • from 24% to 64% for non-commercial sponsors;
  • from 77% to 86% for commercial sponsors.

bron: EMA website ‘Clinical trials in human medicines’


Data Analysis and Real-World Interrogation Network (DARWIN EU)

DARWIN EU collaborates with data partners who help generate real-world evidence that can be used in scientific evaluations and regulatory decision-making. The data partners enable DARWIN EU to use their data in its scientific studies, and provide analysis results to the DARWIN EU coordination centre, in accordance with data protection rules.

bron: EMA website ‘Data Analysis and Real World Interrogation Network (DARWIN EU)’

Data reuse

Decentralized Trials & Research Alliance (DTRA)

Dierexperimenteel onderzoek

Dutch Association of Research Quality Assurance (DARQA)

Dutch Oncology Research Platform (DORP)

EudraCT (European Union Drug Regulating Authorities Clinical Trials Database)

What’s New: From 31 January 2023, sponsors will need to use the Clinical Trials Information System to apply for authorisation of a new clinical trial in the EU/EEA. From this date onwards, EudraCT will no longer allow the creation of new EU/EEA Clinical Trial Application (CTA) for the purpose of submission to National Competent Authorities (NCAs), including creation of CTA(s) in order to add member state(s) to an existing EudraCT trial. See section 11 of the Q&A on Regulation (EU) 536/2014.

EudraCT will remain available to sponsors for: amendments of CTAs that were submitted to NCAs before January 31st, 2023; creation and uploading of PIP/Art 46 trials conducted exclusively in third countries (see FAQs); results submission for all EudraCT trials.

22-11-2022: Sponsors of clinical trials on COVID-19 are reminded to include the term “COVID-19” in the title of their trial (section A.3 of the CTA). Sponsors are also reminded of the importance of timely reporting of SAEs (Serious Adverse Events) and of SUSARs (Suspected Unexpected Serious Adverse Reactions) to the competent authorities, in order to protect the safety of the participants. In addition, we encourage sponsors of COVID-19 trials to post the relevant results as soon as it is feasible, also before the deadline.

14-11-2022: Users have reported issues with uploading CTA XML files on EudraCT. Our IT is currently working on this, we thank you very much for your understanding and patience. Update 21Nov2022: this issue is now solved.

bron: EudraCT public home page

European Medicines Agency (EMA)

Good Clinical Practice (GCP), European Medicines Agency (EMA)

Good Clinical Trials Collaborative

Health Products Regulatory Authority (HPRA) (Ierland)


International Coalition of Medicines Regulatory Authorities (ICMRA)

International Council for Harmonisation (ICH)

Kunstmatige Intelligentie

Methodology, Statistics

Nationaal Comité advies dierproevenbeleid (NCad)

  • E-nieuws Nationaal Comité advies dierproevenbeleid
    • Nieuwe samenstelling NCad
    • Uit EARA News: veel te weinig fondsen voor het goedkeuren van diervrije methoden
    • Symposium over Next level non-animal testing 2 december
    • Biotechnische dagen 7 & 8 december
    • Workshops over ongeriefinschatting en verfijning 25 en 26 januari

NHS Health Research Authority (HRA)

Orphan medicinal products, Weesgeneesmiddelen


QT prolongation, Thorough QT/QTc (TQT) study

Regulatory Science Network Netherlands (RSNN)

Research ethics, Research integrity, Misconduct

Retraction Watch Database

Simultaneous National Scientific Advice (SNSA)

In November 2022, the EU Innovation Network launched the second phase of the simultaneous national scientific advice (SNSA) pilot. SNSA is intended for situations where an applicant wishes to obtain scientific advice from more than one national competent authority (NCA) at the same time. This is meant to enhance the quality and consistency of such advice. Following endorsement by the Heads of Medicine Agencies (HMA), the second phase of the SNSA pilot will run for a two-year period until the end of 2024. It incorporates an optimised procedure to maximise the benefits for both applicants and competent authorities.

bron: EMA website ‘Innovation in medicines’

US Food and Drug Administration (FDA), HIPAA Privacy and Security Rules, Verenigde Staten

Vereniging Innovatieve Geneesmiddelen

Wet zeggenschap lichaamsmateriaal (Wzl)

ZonMw, Hergebruik data, Findable, Accessible, Interoperable and Reusable (FAIR)


Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties

news.bontrop.com events.bontrop.com consultations.bontrop.co