Uitgelicht en gespot op internet (week 41 & 42, 2022)

Hierbij weer een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die zijn gespot op het internet.

Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.


Algemene verordening gegevensbescherming (AVG), European Union-U.S. Data Privacy Framework

Applied Clinical Trials

Association of Clinical Research Organizations (ACRO)

Centrale Commissie Mensgebonden Onderzoek (CCMO)

Clinical trial results reporting, Clinical trial registration

Clinical trials – Verenigd Koninkrijk

Clinical trials, Clinical research

Data delen

Dutch Oncology Research Platform (DORP)

EFGCP’s Children’s Medicines Working Party (CMWP) 

The team has developed an open-access ‘Adolescent Inclusion Decision Tree’ for use by trial sponsors, trial investigators, IRBs/ethics committees, and health regulatory agencies, when a trial with age-inclusive trial design is being explored, developed or reviewed. The tool outlines over-arching principles for consideration, and guides users through 5 categories to ascertain the appropriateness of the clinical trial for adolescent inclusion: (1) disease, (2) product, (3) statistical, (4) operational, and (5) legal & ethical.


ELSI Servicedesk


European Clinical Research Infrastructrure Network (ECRIN)

European Medicines Agency (EMA)

International Council for Harmonisation (ICH)

bron: ICH M11 Template, page 3

This topic was endorsed by the ICH Management Committee in November 2018. This new guideline is proposed to provide comprehensive clinical protocol organisation with standardised content, with:

  • A Template which presents the format and structure of the protocol, including the table of contents, common headers, and contents;
  • A Technical Specification which presents the conformance, cardinality, and other technical attributes that enable the interoperable electronic exchange of protocol content.

bron: ICH Multidisciplinary Guidelines M11 EWG

Medicines and Healthcare products Regulatory Agency (MHRA)

Medische hulpmiddelen en In-Vitro Diagnostica


Nationaal Comité advies dierproevenbeleid (NCad)

Netherlands Research Integrity Network (NRIN)

US Food and Drug Administration

Wet zeggenschap lichaamsmateriaal (Wzl)

World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) 


Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties

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