Uitgelicht en gespot op internet (week 43, 2021)
Hierbij een nieuw overzicht van actualiteiten en nieuwsberichten die de afgelopen week zijn gespot op het internet. Ook de ‘Events‘ pagina en de ‘Consultations‘-pagina zijn weer bijgewerkt.
Algemene verordening gegevensbescherming (AVG)
- GA4GH GDPR Brief: Navigating international data transfers under GDPR: impediments facing US federal science agencies and research universities (22 oktober 2021). GA4GH.
- Gezamenlijke verwerkingsverantwoordelijkheid onder de AVG (22 oktober 2021). KBS Advocaten.
Centrale Commissie Dierproeven (CCD)
Clinical Trials Regulation (CTR), CTIS
- Guidebook: Principles for Sponsor Organisation Modelling for CTIS, Version 2 (update oktober 2021).
- EC Details What to Include in Protocol Synopses Submitted with Trial Applications (25 oktober 2021). WCG CenterWatch.
COmmissie REgelgeving ONderzoek (COREON)
Dutch Clinical Research Foundation (DCRF)
- Aanbevelingen voor een Goede Leken Samenvatting (26 oktober 2021).
- Checklist Lokale Uitvoerbaarheid behorende bij CTR-VGO proces (25 oktober 2021).
- Interview met Stan van Belkum en Monique Al van de CCMO over de CTR en VGO (21 oktober 2021).
European Clinical Research Infrastructrure Network (ECRIN)
- Publication of Good Lay Summary Practice (GLSP) Recommendations (29 oktober 2021).
- Clinical Trials Helpdesk developed by EULAC PerMed (26 oktober 2021).
- New publication – Medical journal requirements for clinical trial data sharing: Ripe for improvement (26 oktober 2021).
- ERIC Forum report on Quality Management and Reproducibility in Academic Research (25 oktober 2021).
European Medicines Agency (EMA)
- Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia (28 oktober 2021).
- Guideline on registry-based studies (22 oktober 2021).
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)
Good Machine Learning Practice (GMLP), Artificial intelligence, Machine learning !
- Guidance – Good Machine Learning Practice for Medical Device Development: Guiding Principles (27 oktober 2021). FDA, Health Canada, MHRA.
- UK, USA and Canadian regulators identify 10 guiding principles to be addressed when medical devices use AI or machine learning software (27 oktober 2021). MHRA.
- Good Machine Learning Practice for Medical Device Development: Guiding Principles (27 oktober 2021). FDA.
- Regulators release 10 principles for good machine learning practice (27 oktober 2021). Regulatory Focus.
Informed consent
NHS Health Research Authority (HRA)
Open Science
- Open Science: the Very Idea (2021). Frank Miedema.
- 26 projecten om open science te stimuleren (27 oktober 2021). ZonMw.
Predatory publishers
US Food and Drug Administration (FDA), Form FDA 1572
- FDA Guidance on Clinical Investigators Signing Form FDA 1572 and Practical Challenges Outside the US (29 oktober 2021). BioSlice Blog, Arnold & Porter.
- FDA Offers Advice on Standardizing Real-World Data for IND Submissions (25 oktober 2021). WCG CenterWatch.
- FDA: Device Trials that Use Leftover, De-Identified Human Specimens Need IRB Review (25 oktober 2021). WCG CenterWatch.
Vereniging van Universiteiten (VSNU)
Overige
- Weekend reads: “Passing the professor,” documented; “tortured phrases;” a “catastrophic failure of peer review” (30 oktober 2021). Retraction Watch.
- The vast majority of genes have been tied to cancer — and that can complicate research (27 oktober 2021). STAT.
- Why do placebos work? Scientists identify key brain pathway (27 oktober 2021). Science.
- Survey: Flexibility in Clinical Trial Approaches is Paramount to Participation (25 oktober 2021). WCG CenterWatch.
- Methods for Calculating PI Compensation: Pros and Cons (25 oktober 2021). WCG CenterWatch.
- When authors stop responding to requests for data, a journal retracts (25 oktober 2021). Retraction Watch.
- Use of Real World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018-2019 (24 oktober 2021). Clinical Pharmacology & Therapeutics.
- Limited data exist to inform our basic understanding of micronutrient requirements in pregnancy (22 oktober 2021). Science Advances.
- Ethics of DNA research on human remains: five globally applicable guidelines (20 oktober 2021). Nature.
- Publisher investigating paper a lucrative scale is based on following Retraction Watch reporting (20 oktober 2021). Retraction Watch.
- mRNA flu shots move into trials (11 oktober 2021). Nature Reviews Drug Discovery.
- mRNA vaccines for infectious diseases: principles, delivery and clinical translation (25 augustus 2021). Nature Reviews Drug Discovery.
- Why should researchers get involved in science policy? (8 oktober 2021). EuroScientist.
- Methodology over metrics: current scientific standards are a disservice to patients and society. Journal of Clinical Epidemiology.
Meer actueel nieuws, bijeenkomsten en publieke consultaties