Longitudinal evaluation of the accuracy and completeness of clinical trial protocols - evidence for improvement?

M. Briel, B. von Niederhäusern, L. Hemkens, S. Schandelmaier, Y. Tomonaga, E. von Elm

Status: Abgeschlossen Dauer: Nov. 2014 - Juli 2017

The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) were published in 2013 and the new Swiss federal Law on Research in Humans (Humanforschungsgesetz, HFG) came into effect in January 2014. The present project aims to investigate the accuracy and completeness of clinical trial protocols approved by Research Ethics Committees before the introduction of SPIRIT & HFG and thereafter. In addition, we will evaluate the extent of appropriately registered protocols before the introduction of SPIRIT & HFG and thereafter (in national or international registries).\n

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