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