PRACTICE GUIDANCE O
FOR CLINIC
This guidance was prepared on behalf of the Pra
Society of Great Britain and the Institute of Clinic
Additional paper copies may be requested by co
Lorraine Fearon
Practice Division
Royal Pharmaceutical Society of Great Britain
1 Lambeth High Street
London
SE1 7JN
Telephone: 0207 572 2409
Email: practice@rpsgb.org
All rights reserved. No part of this publication
system, or transmitted in any form or by any
photocopying, recording or otherwise - witho
Royal Pharmaceutical Society of Great Britai
N PHARMACY SERVICES
AL TRIALS
ctice Division of the Royal Pharmaceutical
al Research.
ntacting:
may be reproduced, stored in a retrieval
means - electronic, mechanical,
ut the prior written permission of the
n.
June 2005
Index
Section
Page
Introduction
2
1.
The Role of Pharmacy Within a NHS Trust
3
2.
Pharmacy Staff
4
3.
Pharmacy Facilities
5
4.
Pharmacy and Resources
6
5.
Prescription Charges
7
6.
Communication Within and Outside the NHS Trust
8
7.
Pharmacy and the R & D Department
9
8.
Ethics Committee
10
9.
Set-up of a Study
11
10.
Approvals
13
11.
Investigational Medicinal Product Management
14
12.
Prescriptions for Clinical Trials
16
Glossary of Terms
17
References
19
Useful Website addresses
21
Index1
Intro.
This practice guidance on pharmacy services for clinical trials has
been produced jointly by the Institute of Clinical Research and the
Royal Pharmaceutical Society of Great Britain and should be used by
pharmacy staff involved with the provision of clinical trials services at
policy, strategic and operational levels.
The guidance applies to all clinical trials that are regulated by the
Medicines for Human Use (Clinical Trials) Regulation 2004. This
includes commercial and non-commercial clinical trials and investigator
initiated clinical research.
The generic terms "pharmacy" or "pharmacy staff" encompass
pharmacists and pharmacy technicians, although it is recognised that
pharmacists and pharmacy technicians may have diffe