This guideline (which replaces EMA/INS/GCP/454280/2010 Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials) describes some…
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Each year the HSRAA is invited to represent the views of archivists at the MHRA GLP StEM (Stakeholder Engagement Meetings). The 2022 StEM will take…
Raw data in electronic structured format is currently not systematically included as part of marketing authorisation and variation applications submitted to EMA. However, the Regulations…
The latest edition of the EMA Clinical Trials Information System (CTIS) Newsletter provides insights on clinical trials topics. Of particular interest to HSRAA members is…
The EMA Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its third workplan that sets key actions to be delivered between 2022–25. For more…
The use of Adobe Sign for creating and managing GxP e-signatures is increasingly sought after by pharmaceutical and healthcare organisations. In this blog, Gianna de Rubertis…
Arkivum has revised and updated its interactive guide to eTMF and clinical data archiving and preservation. Not only is it packed full of expert insights, great tips and…