Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
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Statistician Agreement Page<br />
The cl<strong>in</strong>ical <strong>study</strong> as detailed with<strong>in</strong> this research protocol (Version 2, dated 18/JULY/2012), or<br />
any subsequent amendments, <strong>in</strong>volves the use of an <strong>in</strong>vestigational medic<strong>in</strong>al product and will be<br />
conducted <strong>in</strong> accordance with the Research Governance Framework for Health & Social Care<br />
(2005), the World Medical Association Declaration of Hels<strong>in</strong>ki (1996), Pr<strong>in</strong>ciples of ICH-GCP, and<br />
the current regulatory requirements, as detailed <strong>in</strong> the Medic<strong>in</strong>es for Human Use (Cl<strong>in</strong>ical Trials)<br />
Regulations 2004 (UK S.I. 2004/1031) and any subsequent amendments of the cl<strong>in</strong>ical trial<br />
regulations.<br />
Statistician Name: Professor Peter Sasieni<br />
Professor of Biostatistics & Cancer Epidemiology<br />
Deputy Director, Centre for Cancer Prevention<br />
Site: Wolfson Institute of Preventive Medic<strong>in</strong>e<br />
Signature and Date:<br />
!<br />
Barts and The London School of Medic<strong>in</strong>e and Dentistry<br />
Charterhouse Square<br />
London<br />
EC1M 6BQ<br />
Study: R4RA EudraCT: 2012-002535-28 4 / 34