Uitgelicht en gespot op internet (week 24, 2021)
Hierbij weer een nieuw overzicht van actualiteiten en andere nieuwsberichten die de afgelopen weken zijn gespot op het internet. Ook de ‘Consultations‘ pagina en de ‘Events‘ pagina zijn weer bijgewerkt.
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Algemene verordening gegevensbescherming (AVG), Bescherming persoonsgegevens, Brexit, Standard Contractual Clauses (SCC)
- Formal results of voting on Draft decision on the adequate protection of personal data by the United Kingdom (GDPR) (14 – 16 juni 2021). European Commission.
- Gecorrigeerde tekst van de AVG (niet-officiële versie). Privacy Management Partners.
- All change on international transfers with new Standard Contractual Clauses (15 juni 2021). Fieldfisher Privacy, via LinkedIn.
- SCCs flow-down obligations (16 juni 2021). Renzo Marchini, via LinkedIn.
Centrale Commissie Mensgebonden Onderzoek (CCMO)
- Toetsingstaak CCMO gewijzigd voor bepaalde typen onderzoek (14 juni 2021).
- Wijziging Besluit Centrale Beoordeling, inwerkingtreding Wet medische hulpmiddelen (deels) en uitbreiding ledental CCMO (16 mei 2021). Vincent Bontrop.
Clinical Trials Transformation Initiative (CTTI)
Commissie Regelgeving Onderzoek (COREON)
Council for International Organizations of Medical Sciences (CIOMS)
Dierexperimenteel onderzoek
Embryo onderzoek, Stem-cell research
- ISSCR guidelines fudge heritable human-genome editing (15 juni 2021). Nature.
- Don’t abandon 14-day limit on embryo research, it makes sense (15 juni 2021). Nature.
- Why we should not extend the 14-day rule (10 juni 2021). Journal of Medical Ethics.
- Anticipated impact of stem cell and other cellular medicine clinical trials for COVID-19 (11 juni 2021). Future Medicine.
European Clinical Research Infrastructure Network (ECRIN)
European Medicines Agency (EMA), Clinical Trial Information System (CTIS), EU Clinical Trial Regulation (ECTR), Ccomputerised systems, Electronic data
- Draft guideline on computerised systems and electronic data in clinical trials (End of consultation (deadline for comments) 17 December 2021)
- Highlights of Management Board: June 2021 meeting (18 juni 2021).
The Board welcomed the progress in the development and preparations for ‘go-live’ of the Clinical Trial Information System (CTIS). Following the independent audit reported in April 2021 and the endorsement on full functionality of CTIS by the Board, the publication of the Commission decision is anticipated for 31 July 2021 in the Official Journal of the European Union and go-live is currently on track for 31 January 2022.
The development of CTIS continues as planned and EMA, together with Member States and sponsor experts, are heavily engaged in working on the agreed functionalities for the go-live version of the system.
CTIS is a cornerstone to apply the principles of the Clinical Trial Regulation. Clinical research and patient health in the EU will benefit from the streamlined regulatory processes that the Regulation and CTIS will bring. It is now vitally important that stakeholder organisations, clinical trial sponsors and authorities, prepare their staff and processes to work with CTIS to make use of the strengths that the system and the legislation will bring to their activities.
An extensive online training programme is available and Master Trainer programmes for Member States and sponsors are also ongoing. EMA will organise a public event on 29 July to provide information that will help sponsor organisations to prepare for CTIS.
bron: Highlights of Management Board: June 2021 meeting (18 juni 2021). EMA.
Medicines and Healthcare products Regulatory Agency (MHRA)
Overige
- Drug Discovery Today. Volume 26, Issue 6, Pages 1337-1556 , June 2021.
- Weekend reads: Biotech CEO on leave after allegations on PubPeer; a researcher disavows his own paper; plagiarism here, there, and everywhere (19 juni 2021). Retraction Watch.
- Stop Over-Reporting Adverse Events, FDA Officials Tell Sponsors (14 juni 2021). WCG CenterWatch.
- Ask the Experts: FDA Advice on Protocol Deviations (14 juni 2021). WCG CenterWatch.
- University Outreach Program Increases Black Participation in Cancer Trials (14 juni 2021). WCG CenterWatch.
- Ethical issues in genetics and infectious diseases research: An interdisciplinary expert review (7 juni 2021). Ethics, Medicine and Public Health.
- 6 ways the FDA’s approval of Aduhelm does more harm than good (15 juni 2021). STAT.
- Design of a FAIR digital data health infrastructure in Africa for COVID-19 reporting and research (11 juni 2021). Advanced Genetics.
- Can standardised courses in research ethics prevent publication misconduct? (8 juni 2021). London School of Economics and Political Science.
- FDA Promotes Master Protocols to Modernize Clinical Trials (20 mei 2021). Applied Clinical Trials.
- Patient-Centric Protocol Risk Assessment Tool (updated 27 april 2021). PRA Health Sciences.
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