Transcription of Draft approved by the Cross-Committee Task Force on ...
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Draft approved by the Cross-Committee Task Force on ...
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. 24 September 2020 1 EMA/502388/2020 2 Guideline on registry-based studies 3 Draft 4 5 Draft approved by the Cross-Committee Task Force on Registries May 2020 Draft sent to the EU Regulatory Network for consultation 9 July 2020 Start of public consultation 24 September 2020 End of consultation (deadline for comments) 31 December 2020 6 7 Comments should be included in the form published with this Draft guideline, and should be sent to by 31 December 2020.
119 monitoring of patients, e.g. imaging methods such as CT -scans and laboratory testing, should be 120 strictly limited to normal clinical practice if the registry -based study is not registered as a clinical 121 . trial. 122 Studies based on patient registries may also contextualise the results of uncontrolled trials , provide
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