Uitgelicht en gespot op internet (week 9, 2022)
Hierbij een nieuwe uitgave van het supplement ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet. Er zijn ook weer nieuwe bijeenkomsten en publieke consultaties toegevoegd aan de ‘Events‘ en de ‘Consultations‘-pagina.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Algemene verordening gegevensbescherming (AVG)
- Model DPIA van de Rijksdienst, versie 2.0, d.d. 19-11-2021.
- Template/Rapportagemodel DPIA Rijksdienst.
- Advies aan Nederlandse overheid: gebruik MS Teams niet voor gevoelige informatie (04-03-2022). IB&P.
College ter Beoordeling van Geneesmiddelen
Data sharing
Decentralized clinical trial
Europese Commissie
- Newly applicable Clinical Trials Regulation to benefit sponsors, authorities, patients and the public (28-02-2022).
- Statement by President von der Leyen at the joint press conference on the global mRNA technology transfer hub (18-02-2022).
European Data Protection Board (EDPB)
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
- Overview of the EU PAS Register post-authorisation studies performed in Europe between September 2010 and December 2018 (03-03-2022).
- Overview of the European post-authorisation study register post-authorization studies performed in Europe from September 2010 to December 2018 (29-01-2022). Pharmacoepidemiology and Drug Safety.
European Union Drug Regulating Authorities Clinical Trials Database (EudraCT)
Following the European Commission’s Guidance on results postings, the European Medicines Agency and National Competent Authorities sent rounds of notifications in order to remind sponsors of their responsibilities as regards posting clinical trial results in EudraCT. In an attempt to reach sponsors who have not uploaded results yet, round of reminders are now being sent to email addresses stored not only in EudraCT, but also in other databases, such as the EMA Eudra Common Directory (results user roles list), EudraVigilance, SPOR and Art. 57 database.
The EMA recommends all sponsors to verify if their trials comply with the Guidance on results postings through looking for their sponsor name in EU CTR. To learn how to post results visit Tutorials on posting results.
bron: Nieuwsbericht d.d. 03-03-2022, overgenomen van EudraCT website.
Inspectie Gezondheidszorg en Jeugd (IGJ)
International Agency for Research on Cancer (IARC)
Recruitment, Retentie
Kortom, het is tijd voor een volwassen discussie om deelnemers aan klinisch onderzoek serieuzer te compenseren voor hun extra inspanningen dan de obligate boekenbon of warme woorden van erkentelijkheid in het dankwoord van een proefschrift.
– Marcel Levi, uit Betaal patiënten bij trials (02-03-2022). Medisch Contact.
Research integrity
- How to trust a scientist (juni 2022). Studies in History and Philosophy of Science.
- Co-creating Research Integrity Education Guidelines for Research Institutions. MetaArXiv, 3 Mar. 2022.
- Framework to Enhance Research Integrity in Research Collaborations. Research Integrity in Ireland (2022). National Research Integrity Forum.
- Academics underestimate willingness of PhDs to use fake data (01-03-2022). Times Higher Education.
Site Initiation Visit (SIV)
U.S. Food and Drug Administration (FDA), Verenigde Staten
- Newly added guidance documents
- Comments on RWD registry guidance focus on harmonization, need for details (02-03-2022). Regulatory Focus.
- FDA finalizes three guidances on cancer trials in line with Biden’s ‘Moonshot’ (01-03-2022). Regulatory Focus.
- Beginner’s Guide to Institutional Review Boards (24-02-2022). Advarra.
- Medical Devices: “Significant Risk” Versus “Nonsignificant Risk” Determinations (17-02-2022). Advarra.
- Diversity in Cancer Research: Getting Started (16-02-2022). Advarra.
- Beginner’s Guide to Community-Based Participatory Research (10-02-2022). Advarra.
- Research Involving Cosmetics: What you Need to Know (10-02-2022). Advarra.
ZonMw
Overige berichten
- Weekend reads: An academic and a Russian spy; concussion expert resigns from committee; publishing peer reviews (05-03-2022). Retraction Watch.
- Achieving end-to-end success in the clinic: Pfizer’s learnings on R&D productivity (maart 2022). Drug Discovery Today.
- How doppelgänger effects in biomedical data confound machine learning (maart 2022). Drug Discovery Today.
- Regulatory oversight on the use of experimental therapies during a pandemic: The case of early access to convalescent plasma therapy in three LMICs (maart 2022). Drug Discovery Today.
- The overlooked vital sign: The importance of measuring sleep in drug development studies (maart 2022). Drug Discovery Today.
- Flexibility and understanding how to integrate tech key for trial sites (02-03-2022). Clinical Insider.
- Russische cyberaanval kan ook zorginstelling raken (02-03-2022). Skipr.
- Nederlandse ziekenhuizen stoppen vroegtijdig met studie: bloedverdunners toch te riskant bij verwijderen hersenbloedprop (01-03-2022). De Volkskrant.
- Nederlandse ziekenhuizen moeten alert zijn op Russische cyberaanvallen (28-02-2022). Skipr.
- STAT and MIT rooted out the weaknesses in health care algorithms. Here’s how we did it (28-02-2022). STAT.
- Science Knows No Country: Culture’s Impact on Research Misconduct Proceedings (22-02-2022). Cohen Seglias Pallas Greenhall & Furman PC.
- The spectrum of data sharing policies in neuroimaging data repositories (10-02-2022). Human Brain Mapping.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties