Standard Operating Procedure (SOP) CRF Stock and Equipment Control

Transcription

1 York Foundation Trust R&D Unit SOP CRF/S86 Standard Operating Procedure (SOP) CRF Stock and Equipment Control IT IS THE RESPONSIBILITY OF ALL USERS OF THIS SOP TO ENSURE THAT THE CORRECT VERSION IS BEING USED All staff should regularly check the R&D Unit s website and R&D Newsletter for information relating to the implementation of new or revised versions. Staff must ensure that they are adequately trained in the new procedure and must make sure that all copies of superseded versions are promptly withdrawn from use unless notified otherwise by the SOP Controller. The definitive versions of all R&D Unit SOPs appear online. If you are reading this in printed form check that the version number and date below is the most recent one as shown on the R&D Unit website: SOP Reference: CRF/S86 Version Number: 3.0 Nelisa Poshai Implementation date of current version: 6 th February 2015 Approved by: Name/Position: Signature: Damon Foster, Head of R&D Signed copy held by R&D Unit Date: 6 th January 2015 Name/Position: Sarah Sheath, SOP Controller Signature: Signed copy held by R&D Unit Date: 6 th January 2015 This SOP will normally be reviewed every 2 years unless changes to the legislation require otherwise York Teaching Hospital NHS Foundation Trust 2015 All Rights Reserved No part of this document may be reproduced, stored in a retrieval system or transmitted in any form or by any means without the prior permission of York Teaching Hospital NHS Foundation Trust.

2 CRF Stock and Equipment Control Version History Log This area should detail the version history for this document. It should detail the key elements of the changes to the versions. Version Date Implemented Details of significant changes nd October th November 2012 Removal of forms from SOP to make formal SOP form template th February 2015 Incorporates Unit name change Version 3.0

3 CRF Stock and Equipment Control Page No Version 2 1 Introduction, Background and Purpose 1 2 Who Should Use This SOP 1 3 When this SOP Should be Used 1 4 Procedure(s) 1 5 Related SOPs and Documents 2 Version 3.0

4 CRF Stock and Equipment Controll 1 Introduction, Background and Purpose The York Clinical Research Facility (CRF) supports the conduct of a broad range of clinical research studies involving healthy volunteers and patients (subjects). It is important to ensure all consumables used in a study are within their expiry date and fit for purpose. Likewise, all equipment used, should be serviced, calibrated and records available for inspection. This supports compliance with the UK Clinical Trials Regulations. 2 Who Should Use This SOP This SOP applies to CRF staff and all clinical research teams undertaking trials within CRF. 3 When this SOP Should be Used This SOP should be used weekly when restocking the trolley and monthly (the first week of each month) for a full CRF stock check and ordering. This SOP should be used at the beginning of a new trial to check that any equipment to be used is calibrated and in good working order then, monthly (first week of each month) when trials are ongoing. 4 Procedure(s) STOCK Weekly stock check: Check trolley contents for expiry dates and restock according to current trial needs. Order replacement stock for supplies that are running low (be aware stock takes a week to arrive). Complete and sign checklist. Monthly stock check: Check all stock held in CRF store, including stock drugs, laboratory solutions and consumables for expiry date. Order replacement stock as required. Out of date stock can be given to the Medical School clinical skills facilitator for use or disposed of in an appropriate way according to York Hospital Waste Management Policy. Complete and sign checklist. EQUIPMENT Prior to the start of a trial: At least four weeks before a trial start date, there is a full list of equipment held in the CRF held on the CRF X drive. Version 3.0 Page 1 of 2

5 CRF Stock and Equipment Controll Make a list of all equipment to be used, check service dates and calibration records, and request servicing/calibration if required. Retain service/calibration records in Trial Site File. Ask the Clinical Trials Assistant to put an alert on the CRF calendar when next service due. Monthly equipment check: Check all in use equipment service and calibration records, consider visits scheduled and the length of time it takes for servicing to take place i.e. Do not wait until equipment is out of date. Request any servicing/calibration. Please note some pieces of equipment particularly in the laboratory will be serviced through the University of York if unsure check with the senior nurse on duty. The following week check to see if servicing/calibration have taken place and chase as required. York Hospital Service department contact details: Red sticker CRF telephone: 6331 quoting the asset number. Blue sticker Facilities telephone: 5566 quoting the asset number. 5 Related SOPs and Documents York Hospital Medical Devices Management Policy Waste Management Policy and procedure R&D/S09 Set up and Management of Research Studies CRF/F86 Stock Control Form Version 3.0 Page 2 of 2