Monitoring strategies for clinical intervention studies

Author:

Klatte Katharina1,Pauli-Magnus Christiane1,Love Sharon B2,Sydes Matthew R2,Benkert Pascal1,Bruni Nicole1,Ewald Hannah3,Arnaiz Jimenez Patricia1,Bonde Marie Mi1,Briel Matthias1

Affiliation:

1. Department of Clinical Research; University Hospital Basel and University of Basel; Basel Switzerland

2. MRC Clinical Trials Unit at UCL; University College London; London UK

3. University Medical Library; University of Basel; Basel Switzerland

Publisher

Wiley

Subject

Pharmacology (medical)

Reference131 articles.

1. Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials;Brosteanu;Clinical Trials,2009

2. Risk-adapted monitoring is not inferior to extensive on-site monitoring: results of the ADAMON cluster-randomised study;Brosteanu;Clinical Trials,2017

3. Study protocol ("Prospektive cluster-randomisierte Untersuchung studienspezifisch adaptierterStrategien für das Monitoring vor Ort in Kombination mit zusätzlichenqualitätssichernden Maßnahmen") www.tmf-ev.de/ADAMON/Downloads.aspx

4. Cost-effectiveness of full versus targeted monitoring of randomized controlled trials;Fougerou-Leurent;Fundamental & Clinical Pharmacology,2018

5. Impact of a targeted monitoring on data-quality and data-management workload of randomized controlled trials: a prospective comparative study;Fougerou-Leurent;British Journal of Clinical Pharmacology,2019

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