Hierbij een nieuw overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet.
Ook zijn de ‘Events‘ pagina en de ‘Consultations‘ pagina weer voorzien van nieuwe nieuwe evenementen en publieke consultaties.
Algemene verordening gegevensbescherming, Persoonsgegevens
- Assessment of the EU Member States’ rules on health data in the light of GDPR (2021). DG Health and Food Safety.
- Commission publishes study on Assessment of the EU Member States’ rules on health data in the light of GDPR. European Commission.
- Publication on the application of the GDPR concerning health data (12 februari 2021). MLCF.
- EDPB Publishes New Guidance for Data Breach Notification (11 februari 2021). LexBlog.
Centrale Commissie Mensgebonden Onderzoek
Clinical development
- Questions Optimizing Calculator.
This tool lies at the heart of the question-based approach to clinical development. It aims to answer the central question: “What are the key scientific questions and what is the estimated priority ranking to address them?” The Question Based Clinical Development (QBCD) approach redefines the developmental pathway of new medical interventions based on a number of key questions.
Clinical Trial Regulation (ECTR), Clinical Trials Information System (CTIS)
Clinical Trials, remote Source Data Verification
College Klinische Proeven, Federale Overheidsdienst Volksgezondheid, Veiligheid van de Voedselketen en Leefmilieu (België)
COVID-19
- EMA preparing guidance to tackle COVID-19 variants (10 februari 2021). European Medicines Agency.
- International regulators working together to enhance collaboration on COVID-19 observational research (8 februari 2021). European Medicines Agency.
- Hoe hard moet het bewijs zijn in een pandemie? (8 februari 2021). Medisch Contact.
- COVID-19 Variants Won’t Require New Phase 3 Vaccine Trials, Just Small Safety Studies (8 februari 2021). WCG CenterWatch.
- U.S. Leads Global Surge in COVID-19 Clinical Trials, Report Says (8 februari 2021). WCG CenterWatch.
- Guidance on the management of clinical trials during COVID-19 pandemic (versie 4, 4 februari 2021). European Medicines Agency.
- An ethics framework for consolidating and prioritizing COVID-19 clinical trials (2 februari 2021). Clinical Trials.
- Racial Diversity within COVID-19 Vaccine Clinical Trials: Key Questions and Answers (26 januari 2021). KFF.
- The Current Status of European Research Related to COVID-19: The EUCROF Perspective (25 januari 2021). Applied Clinical Trials.
- Fieldlab Evenementen: ondanks strengere maatregelen toch testen met publiek. Sportinnovator.
Dierexperimenteel onderzoek
Dutch Clinical Research Foundation (DCRF)
- Remote Source Data Verificatie – Opinie-enquête (11 februari 2021).
- Elektronische investigator site file (11 februari 2021).
- Oproep aan alle ziekenhuizen die wetenschappelijk onderzoek doen: (7 februari 2021).
- Voorbereiden op de ECTR – training CTIS (7 februari 2021).
Dutch Oncology Research Platform (DORP)
Dutch Techcentre for Life Sciences
International Committee of Medical Journal Editors (ICMJE)
Office of Research Integrity (ORI)
Organisation for Economic Co-operation and Development (OECD)
- Making data for science as open as possible to address global challenges (20 januari 2021).
- Recommendation concerning Access to Research Data from Public Funding,
Participation, Patient engagement
- BMS’s Patient Advocacy in Pivotal Trials Program Goes Virtual (8 februari 2021). WCG CenterWatch.
- Toolkit participatie – Interview Frank Jan de Jong & Leonie Vergouw (z.d.). Alzheimer Nederland.
- A practical guide to patient and public involvement in lab-based research. Parkinson’s UK, Alzheimer Society & NIHR University Collega London Hopsitals Biomedical Research Centre.
- Informed consent for neonatal trials: practical points to consider and a check list. BMJ Paediatrics Open 2020;4:e000847.
- Involve Children and Parents in Clinical Studies. Clin Transl Sci. 2020 Jan;13(1):11-13. doi: 10.1111/cts.12696. Epub 2019 Oct 24.
Publications
Research integrity
TransCelerate BioPharma Inc.
- The Pulse on Progress: TransCelerate Shares Fourth Quarter Highlights (9 februari 2021).
- The Importance of Harmonizing Clinical Trial Content, Especially in a Post-Pandemic World.
UMC Utrecht
Overig
- Toward Guidelines for Research on Human Embryo Models Formed from Stem Cells (11 februari 2021). Stem Cell Reports.
- Gene Therapy Trials to Get New Guidances in 2021, FDA’s Biologics Center Says (8 februari 2021). WCG CenterWatch.
- Ask the Experts: Complying with IRB Requirements and Other Issues (8 februari 2021). WCG CenterWatch.
- The next act for messenger RNA could be bigger than covid vaccines (5 februari 2021). MIT Technology Review.
- Assessing the climate for research ethics in labs: Development and validation of a brief measure (4 februari 2021). Accountability in Research.
- National Institute of Mental Health recruitment monitoring policy and clinical trial impact (1 februari 2021). Contemporary Clinical Trials.
- Towards the Tipping Point for FAIR Implementation (31 januari 2021). Data Intelligence.
Raadpleeg het weblog voor een overzicht van het laatste nieuws, bijeenkomsten en publieke consultaties.
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