STANDARD OPERATING PROCEDURE SOP 345 Identifying Trial Patients on Hospital Admission Version 1.3 Version date 22/02/2018 Effective date 24/02/2018 Number of pages 6 Review date January 2020 Author Role NNUH UEA Joint Research Office Approved by Role Signature Melissa Cambell-Kelly Research Matron Date 22/02/2018 Authorized on behalf of NNUH and UEA by Role Professor Alastair Forbes Chief of Research and Innovation Signature Date 24-2-18 Page 1 of 6
It is the responsibility of all users of this SOP to ensure that the correct version is being used. All staff should check the NNUH website for information relating to the implementation of new or revised versions of SOPs. Staff must ensure that they are adequately trained in the new procedure and must make sure that all copies of superseded versions are promptly withdrawn from use. The definitive version of all Joint NNUH/UEA healthcare research SOPs appear online. If you are reading this in printed form please check that the version number and effective date is the most recent one as shown on the R & D website. TABLE OF CONTENTS 1 ABBREVIATIONS 3 2 INTRODUCTION 3 3 SCOPE 3 4 RESPONSIBILITY 3 5 PROCEDURES 4 5.1 Alerts on PAS 4 5.2 Attaching Labels to Patient Notes 4 5.3 Copy of Patient Consent Form 4 6 REFERENCES 5 7 RELATED DOCUMENTS 5 8 LIST OF APPENDICES 5 Appendix 1 : Change Control, Revision and Review Sheet 6 Page 2 of 6
1 ABBREVIATIONS IT NNUH PAS R & D SOP UEA Information Technology Norfolk and Norwich University Hospitals Patient Administration System Research and Development Standard Operating Procedure University of East Anglia 2 INTRODUCTION The aim of this SOP is to describe the procedures to be followed to ensure there is sufficient information within NNUH patient information systems (patient notes and electronic records) to allow identification of patients that are involved in Clinical Trials on hospital admission. This identification is necessary to ensure that staff are aware that the participant is part of a clinical trial involving medicine and/or treatment that might impact on their care. It also allows trial investigators to be aware that their participant has received additional care outside of the trial and to assess if these events influence their trial participation and to complete the necessary paperwork. 3 SCOPE This SOP applies to all research studies which involve the use of NNUH patient information systems, such as patient notes, electronic records and PAS as part of clinical trial or research study activity. 4 RESPONSIBILITY It is the responsibility of the local investigator, or delegate, to ensure that information about trial activity is recorded and kept up-to-date in the relevant patient information systems, and that where activity relates to a clinical trial it is clearly stated which trial this relates to. The R & D Office issues unique registration numbers for all research approved by the Trust and this number should be used as part of the identification process. It is also their responsibility to ensure that patients have information about who to contact in relation to their trial involvement. Contact numbers for the research team should be provided in the Patient Information Sheet, and patients should be issued with a Participant s Contact Card where appropriate (See SOP 510 Medical Cover Section 4). Page 3 of 6
5 PROCEDURES 5.1 Alerts in PAS Alerts should be placed on the PAS system to identify that a patient is participating in research. This is a patient has a medical condition alert (the image is a doctor s bag with a red cross on it). In this alert section of PAS free text can be entered, which should include the patient s trial reference and a contact email or number as to who should be informed. This information is available to the receptionist when a patient is admitted and can be passed on to the admission team. An email alert can also be placed and the details of the recipient of the email should be determined by the local investigator in consultation with the NNUH IT Department. A new alert can be added by staff who have access to this part of the PAS system. 5.2 Attaching Labels to Patient Notes Research Labels (yellow label) must be fixed to the inside front cover of the case notes. Information on the label is important for health records to determine how long the records require retention. An ALERT label should also be placed on the outside front of the notes to draw attention to the information sticker inside the cover. Ophthalmology & Obstetrics maintain separate notes so where a patient has both Trust and individual Health Records folders and an alert initiated, both folders must have labels attached. 5.3 Copy of Patient Consent Form Patient participation in a clinical trial must be recorded in the notes, detailing the version of the Patient Information Sheet which the patient has seen, the version of the Consent Form signed, the name of the clinician/ researcher to whom written consent has been given and confirming that the trial Inclusion/Exclusion criteria have been met and the patient has been given opportunity to ask any questions. A photocopy of the Patient Consent Form should be placed in the patient notes in accordance with Trust Guideline GUI003. A copy of the Patient Information Leaflet should also be placed in the notes alongside this to inform other hospital staff of the basic information regarding the research trial in which the patient is involved. Any subsequent visits and ongoing verbal consent from patient to continue needs to be provided and documented in medical notes. ALL approaches to potential participants should be detailed in patient notes so that other researchers are aware of previous discussions and whether the Page 4 of 6
patient has a preference about whether they would like to be approached further. 6 REFERENCES NNUH Health Records: TPU5 - Case Notes Labels Usage NNUH Health Records: TPU9 - Alerts 7 RELATED DOCUMENTS SOP 510 Medical Cover 8 LIST OF APPENDICES Appendix 1: Change Control, Revision and Review Sheet Page 5 of 6
Appendix 1: Change Control, Revision and Review Sheet Revision Form: SOP 345 Version No Change Date Reason for Change 1.2 01/01/2014 Never authorised as v1.1 when updated to incorporate R & D and REN Office processes. Addition to procedure to include copy of Consent Form in patient notes and combining of SOP control and revision sheets. 1.3 30/01/2017 Additional comments added to the procedure section including alerts on PAS, labels to patient notes and copies of consent forms. Reviewer: Noreen Cushen Designation: Lead Research Nurse and CRF Manager Reviewer: Jocelyn Keshet-Price Designation: Band 7 senior Research Nurse Signature and Date: 18/12/2013 Provided by email 30/01/2017 Page 6 of 6