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Life Sciences 2010: Delivering the Blueprint The Office of Life Sciences has published
a report describing the progress that has been made since Government created the Office for Life Sciences in January 2009 to strengthen research in the life sciences, and laying out plans for future work.
EMEA – FDA Good Clinical Practice Initiative The European Medicines Agency has published
a GCP initiative document outlining a process which focuses on enhanced and systematic Good Clinical Practice related information exchanges between the European Medicines Agency and the US Food and Drug Administration combined with collaboration in the conduct of Good Clinical Practice inspections of clinical trials.
Revised 'Defining Research' leaflet NRES have released their
updated leaflet for ‘Defining Research’ which now also aims to distinguish surveillance and usual practice from research, service evaluation and audit.
Preparing raw clinical data for publication: Guidance for journal editors, authors, and peer reviewers New guidance published on the British Medical Journal (BMJ) website in late January sets out how personal information from clinical trials should be shared to help minimize risks to patient privacy. They advise researchers to seek informed consent about data sharing and list 28 items of personal and clinical information that can make patients identifiable in anonymised datasets.
Guidance on requesting amendments to health and social care records The NIGB have launched the
'Guidance on requesting amendments to health and social care records' on the 14 January 2010.
Last updated: 22 February 2010