Standard Operating Procedure (SOP)
SOP number:
SOP-JRO-24-001
SOP full title:
Out of Hours Emergency Cover
SOP effective:
24 Jan 2017
Review date:
24 Jan 2019
SOP author signature:
SIGNED COPY HELD WITHIN THE NJRO
Jack Oliver, Research Management & Governance Manager, Research & Development
SOP approval signature:
SIGNED COPY HELD WITHIN THE NJRO
Ms Susan Ridge, Research Governance Manager, Research & Development
SOP HISTORY
Version
Date
Reason for change
1. BACKGROUND/INTRODUCTION
Good Clinical Practice (GCP) guidelines require sponsors to have a system in place to
enable trial participants and medical personnel to contact a member of the trial team
outside usual clinical hours.
2. PURPOSE
This document describes the procedure for verifying emergency Out Of Hours (OOH)
contact details are current and correct in that they provide contact with appropriate
medical or trial staff.
Out of Hours Emergency Cover - Testing and Monitoring Access
SOP Template Version 1.1, 12-2-12
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SOP-JRO-24-001
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3. SCOPE
This SOP is intended for use by all staff who are involved in the setup, verification and
monitoring of emergency contact details provided for clinical research studies connected
to the Newcastle upon Tyne Hospitals (NuTH) Foundation Trust.
4. PROCEDURE
It is the responsibility of the Chief Investigator (CI) (if single site) or Principal
investigator (PI) to ensure that:
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4.1
The OOH contact details provided to participants are current and correct
The OOH contact details provided to the site switchboard are current and correct
Formal testing of the system is carried out, prior to the first patient appointment,
to provide evidence that an emergency response is in place OOH.
Patient information
4.1.1. Each trial participant will receive a trial Alert Card which will detail the PI’s
contact details and site central switchboard telephone number for advice in an
emergency both during and out of office hours. Trial participants will be advised
to carry this card at all times.
Where the site is part of NuTH, participants must be advised to use the NuTH
switchboard telephone number (0191 2336161) OOH.
4.2.
Setup of OOH emergency cover system
4.2.1. Site Switchboard must be informed of the trial and provided with the agreed
emergency OOH contact details.
Where the site is part of NuTH, the following details are to be forwarded to
switchboard via e-mail ([email protected]).
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4.3.
Trial title
Trial acronym (if applicable)
Contact details for use during working hours
Contact details for use OOH
End date of the OOH contact requirement (if known)
Initial testing of the OOH emergency cover system
4.3.1. An emergency OOH test record must be completed containing as a minimum the
following trial details; Trial title, Site (R&D) identification number, EudraCT
number (if applicable), and PI contact details.
4.3.2. A test call will be made outside of normal working hours (i.e. Monday to Friday
5.00pm – 9am, weekends and bank holidays.
Out of Hours Emergency Cover - Testing and Monitoring Access
SOP Template Version 1.1, 12-2-12
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SOP-JRO-24-001
Friday, 28 July 2017
This document is designed for on-line viewing.
Printed copies, although permitted, are deemed Uncontrolled 7days after the date above
4.3.3. The tester must be able to speak to either: a member of the trial team; or an
on-call member of staff who is able to locate details of the protocol/ participant
and provide suitable advice.
4.3.4. A record must be kept of the date and time the test was made and the outcome.
4.3.5. If an appropriate person was contacted, then the record must be marked as
complete, signed, dated, a copy stored in the Trial Master File and, a copy
forwarded to NuTH R&D.
4.3.6. The call is considered unsuccessful if the switchboard team are unable to make
any contact on the telephone number(s) provided for any reason, including a
wrong number or continuous ringing; unable to speak to anyone on the
telephone number provided with access, understanding or experience of the trial
or trial related documentation.
4.3.7. Any unsuccessful test calls should be documented and participants should not be
recruited until a successful test call has been completed.
4.4.
Intermittent monitoring of OOH emergency cover arrangements
It is the responsibility of NuTH R&D delegated staff for monitoring the OOH medical
cover arrangements and intermittently testing the system for all appropriate and
active clinical trials sponsored by NuTH.
4.4.1. NuTH R&D delegated staff will intermittently test the OOH contact details
provided to NuTH switchboard on randomly selected clinical trials for as long as
there is participant involvement.
4.4.2. Testing of the contact details will be conducted as per points 4.2.3 to 4.2.7.
4.4.3. Tests should continue until a successful test call has been completed.
4.4.4. The outcome of each test call is to be reported back to the CI/ PI and a printed
report should be forwarded for filing in the Trial Master File.
5. REVIEW AND MONITORING OF THIS DOCUMENT
This SOP must be reviewed every 2 years or if there is significant revision to the process,
or changes to legislation which dictate otherwise.
The use of the SOP will be monitored during the annual audit cycle of research projects
performed by or on behalf of NuTH R&D.
Out of Hours Emergency Cover - Testing and Monitoring Access
SOP Template Version 1.1, 12-2-12
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SOP-JRO-24-001
Friday, 28 July 2017
This document is designed for on-line viewing.
Printed copies, although permitted, are deemed Uncontrolled 7days after the date above
6. REFERENCES
MHRA: Good Clinical Practice for Clinical Trials
https://www.gov.uk/guidance/goodclinical-practice-for-clinical-trials
7. APPENDICES
N/A
Out of Hours Emergency Cover - Testing and Monitoring Access
SOP Template Version 1.1, 12-2-12
Page 4 of 4
SOP-JRO-24-001
Friday, 28 July 2017
This document is designed for on-line viewing.
Printed copies, although permitted, are deemed Uncontrolled 7days after the date above