From Anthea Mould Head of Clinical Support, NIHR Clinical Research Network
Release of "Guidance on information requirements for local pharmacy review of research studies. A guidance document for NHS/ Sponsors/ CROs on the information required to support local pharmacy review, trial preparation and set up of research studies" (Version 2)
Many of you will be aware that the NIHR Clinical Research Network has been undertaking a continuous improvement project in conjunction with the National Pharmacy Clinical Trials Advisory Group, Sponsors and other key partners. The objective of this is to streamline elements of clinical trial set up and delivery. Following a scoping exercise and using feedback from commercial sponsors , ' Local Pharmacy Study Review' emerged as the area where the biggest gains could be made.
Version 1 of the guidance developed was tested by more than 20 Trusts in excess of 100 studies. Feedback from the sites has now been incorporated into the documents. Version 2 of the guidance along with some background information and FAQs can be found at http://bit.ly/crnlocalpharmacyreview In testing out this guidance, sites found that where information from commercial sponsors is forthcoming including the prompt response to queries, the majority of reviews were turned around by pharmacy teams within 10 working days
What Next ? NHS sites are advised that this document has been released to commercial sponsors for use with immediate effect. We have also referenced this through the Commercial Costing Template. Please make your teams aware of this guidance and incorporate it into your procedures as soon as possible. Further information on the website includes the applicability of this guidance for non-commercial studies.
Commercial partners will continue to test out the guidance and feedback on its impact - documents for use by sponsors during phase 2 of the pilot can also be found on the same web page.
Feedback and questions? You can feedback via the website or contact the following members of the team directly.
Anthea Mould, Head of Clinical Support Clinical Research Network Tel 0113 343 9080/ 07825608389 [email protected]
Mandy Wan, Paediatric Research Pharmacist Mobile: 0788 1511317 [email protected]
Julie Shenton, Lead Pharmacist Clinical Trials Tel. 0845 602 6772 ext 6891 [email protected]
The NIHR Clinical Research Network and the National Pharmacy Clinical Trials Advisory Group along with the Commercial Clinical Operations Group would like to thank all the staff and teams who were involved in developing this initiative and for your involvement in the pilot.