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SOP No. 13 Authorised Signatory
SOP Title Authorised Signatory
SOP No. SOP 13
Author Tanweer Ahmed
Consultation Undertaken by : Lincolnshire Clinical Research Facility, Research &
Development, research staff and Trust R & D Committee
Lead Manager Sign and Print Name
Dr. Tanweer Ahmed Director of Lincolnshire Clinical
Research Facility & R & D Manager/IP Lead
Date published 11 May 2012
Review date of SOP 10 May 2014
Version 1
1. Purpose:
All research, which takes place in or has links with the Trust, MUST NOT start
without written approval from the United Lincolnshire Hospitals NHS Trust R
& D Department (i.e. any research project, which involves ULH staff, human
subjects, patients, patients data and/or their tissue samples, ULH premises or
facilities, needs approval from the R&D Department prior to commencement),
(Research Governance Framework, 2nd edition 2005). The purpose of this
standard operating procedure (SOP) is to ensure that the R & D Department
provides clear guidelines to Principal Investigators (PI), Chief Investigators
(CI), research nurses/officers/researchers/ULH and external staff for
obtaining appropriate approval from relevant department(s) where the
research studies or clinical trials have direct or indirect resource (staff and or
running costs) implication. All researchers are required to obtain the
necessary approval from the Clinical Director of their department or Business
Unit except in the case of nurses/midwifery projects where they need
approval from the relevant matron. In addition, researchers are also required
to obtain approval from all supporting departments (i.e. Pharmacy, Radiology,
Nuclear Medicine etc) involved in or have resource implications with the
proposed research study/clinical trial. The complete research project
application with all supporting documents should be submitted to the relevant
R & D teams (CLRN for portfolio and the Trust R & D for non-portfolio) for the
Trust approval. If the clinical trial has excess drug or treatment costs then the
researchers are required to produce a short Business Case which will require
approval from the Trust Investment Programme Board.
2. Applies to:
This procedure applies to all researchers (doctors/nurses/allied health
professionals), either employed by the ULH Trust or external organisations.
3. Relevant SOP Documentation
4. Definitions: Chief Investigator – CI Standard Operating Procedure - SOP Principal Investigator – PI Lincolnshire Clinical Research Facility-LCRF
5. Policy: (Relevant literature supporting statement) Research Governance Framework, 2nd edition, 2005 http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4108962
National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP) http://www.crncc.nihr.ac.uk/Resources/NIHR%20CRN%20CC/CSP/Documents/NIHR%20CSP%20Operating%20Manual%20v5_1%2020%2007%202011.pdf The Medicines for Human Use (Clinical Trials) Regulation 2004 and any subsequent amendment http://www.legislation.gov.uk/uksi/2004/1031/contents/made
6. Procedure: (Direction for use of SOP)
This procedure is written to provide clear guidelines for researchers (either
employed by the ULH Trust or external organisations) to obtain the necessary
authorisation before they submit a research project or clinical trial to the
Research Governance teams (portfolio and non-portfolio) for the Trust NHS
Permission.
It is the Principal Investigator’s (PI) or Chief Investigator’s (CI) responsibility to
obtain the necessary authorisation before submitting the research project and
supporting documents for the Trust NHS Permission. For example if the PI or
CI is employed by the Oncology Department and the proposed clinical trial
requires extra scans (see also appendices 1 & 2) and drug dispensing then
the PI or CI (In LCRF, most of PIs delegate responsibility to research
nurses/officers/data managers) is required to obtain the necessary approval
from the Head of Radiology and the Pharmacy Department, in addition to
approval from the Oncology Clinical Director. Within the LCRF some of these
responsibilities (i.e. completing SSI, obtaining necessary authorisation etc)
may be delegated to LCRF manager/cancer team leader/research
nurses/data manager/supporting staff.
If the clinical trial involves excess treatment costs then the PI or CI (or
delegated staff member within LCRF) is also required to produce a short
business case to be presented to the Trust Investment Programme Board. If
the trial has excess treatment costs then please contact, Dr. Tanweer Ahmed
as soon as possible to avoid any delay for further detail in producing a short
business case. The Trust Investment Programme Board meetings are
managed by Trevor Davison (Associate Director of Finance).
Services provided by the Business Units and names of Clinical Directors
(authorised signatories)
1. Services provided by the Women and Children’s Business Unit-
Boston and Grantham:
Authorised Signatory-Clinical Director (Dr. Zafar Ahmed); Deputy- (Mr Magd)
- Pan Trust
2. Services to be provided by the Women and Children’s Business
Unit- Lincoln and Louth :
Authorised Signatory-Clinical Director (Dr. Suresh Babu); Deputy (Maria
Wilde)
3. Services to be provided by Head and Neck Business Unit- Pan
Trust:
Authorised Signatory-Clinical Director (Mr Martin Clark); Deputy (TBC)
4. Services to be provided by the General Surgery Business Unit-
Boston (including the Bostonian):
Authorised Signatory-Clinical Director (Ambika Anand); Deputy (Mr.Greg
Ortonowski)
ry (Pan Trust) *
5. Services to be provided by the General Surgery Business Unit-
Lincoln and Louth:
Authorised Signatory- Clinical Director (Dr. Andrew Simpson); Deputy (TBC)
• NB Both urology and vascular surgery will be managed on a Pan Trust
basis,
6. Services to be provided by the Business Unit for Oncology and
Haematology-Pan Trust:
Authorised Signatory-Clinical Director for Haematology (Dr. Saravanamuttu);
Deputy - Clinical Director for Oncology (Dr. M. Panades); Deputy (Dr.
Saravanamuttu)
7. Services to be provided by the Business Unit for Medicine and
A&E –Lincoln:
Authorised Signatory-Clinical Director (Dr. Richard Andrews); Deputy (TBC)
Gastro
8. Services to be provided by the Business Unit for Medicine and
A&E - Boston & Skegness:
Authorised Signatory-Clinical Director (Dr. Oluwole Adeyemi); Deputy (Dr.
David Boldy)
- Pan Trust
9. Services to be provided by the Medical Specialties Business Unit-
Pan Trust:
Authorised Signatory- Clinical Director (Dr. Batsi Chikura); Deputy (TBC)
-physiology
10. Services to be provided by the Grantham Business Unit:
Authorised Signatory-Clinical Director (Dr. Dilip Mathur); Deputy (Dr. Andy
Houghton)
- including EAU
oracic medicine
11. Services to be provided by the Louth Business Unit:
Authorised Signatory-Clinical Director (Mr R. M. Nayak); Deputy (Mr Paul
Walker)
- including medical and surgical
12. Services to be provided by the Orthopaedics Business Unit –
Lincoln:
Authorised Signatory-Clinical Director (Mr Michael Feeney); Deputy (TBC)
13. Services to be provided by the Orthopaedics Business Unit –
Boston:
Authorised Signatory-Clinical Director (Mr Motkur Prabhaker); Deputy (TBC)
14. Nurses/midwifes/Allied Health Professionals
Matron of the Department/Unit
Supporting Departments and names of authorised signatories.
1. Pharmacy
Authorised Signatory-Chief Pharmacist (Jacqui Miller)-but please contact
Caroline Taylor (Senior Clinical Trials Pharmacist) in the first instance
2. Radiotherapy Physics
Head of Radiotherapy Physics (Martin Cawley)
3. Radiotherapy
Operational Lead for Radiotherapy (Angela Turbin)
4. Radiology
Head of Radiology (Andrew Prydderch)
5. Chemotherapy
Please contact chemotherapy sister (Tracy Wilson) for Lincoln Hospital and
chemotherapy sister (Mandy Dawson) for Pilgrim Hospital
6. IRMER Procedure
Michael Wynn-Jones or Dr. Idris Robert
See Appendix 1 and 2 for detail
7. Path Link
1) Cellular Pathology
Fraser Sim
2) Blood Sciences
Chris Charlesworth
3) Microbiology
Brian Davies and Mark Cioni
4) Immunology
Richard Cartwright
8. Occupational Therapy
Associate Director of Patient Services-Therapy (Anita Cooper)
9. Physiotherapy
Trust Lead Physiotherapist (Neil Ellis)
9. Speech and Language Therapy
Speech and Language Therapy Clinical Coordinator (Phillipa Monteith)
7. Responsibilities It is the responsibility of the PI or CI to ensure that the SSI form is completed
and to obtain all necessary authorisations from all those supporting
departments where the research study or clinical trial has direct or indirect
resource (staff and or running costs) implications. This should be done before
submitting the research project or clinical trial for RM & G assessment and
Trust NHS Permission.
In ULH, on occasions, PIs or CIs delegate this responsibility to the LCRF
Manager, Cancer Team Leader, research nurse or data manager.
8. References: Research Governance Framework, 2nd edition, 2005 http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4108962
National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP) http://www.crncc.nihr.ac.uk/Resources/NIHR%20CRN%20CC/CSP/Documents/NIHR%20CSP%20Operating%20Manual%20v5_1%2020%2007%202011.pdf
The Medicines for Human Use (Clinical Trials) Regulation 2004 and any subsequent amendment http://www.legislation.gov.uk/uksi/2004/1031/contents/made
This SOP will be reviewed every two years; a more updated revision of the SOP will be implemented if new local, national or international regulations/guidelines changes. This would then replace the existing document. All SOP’s can be located on the Research and Development’s shared file and a hard copy of all SOP’s are kept in the Trial Master File
Appendix 1
Does the research protocol include any procedures that
involve ionising radiation?
Ionising radiation procedures include: Medical treatment under guidance of X-ray
imaging X-Rays, CT, fluoroscopy
Breast screening Nuclear medicnie
Dexa Radiotherapy
Non-ionising radiation procedures include:
MRI
Ultrasound
YES NO
NB. Please note, Section 2c of the NHS REC / IRAS form poses the question of whether the project involves ionising radiation, if the answer is yes to this question, the form will then automatically generate further questions and populate the relevant parts of the SSI as required.
If the research protocol includes medical exposures that involve ionising radiation, even if it is part of normal patient care, Schedule 1 IRMER procedure 8 must be completed by the Principal
Investigator (PI)/Research Nurse. Please liaise with Head of Radiation Protection and R&D at earliest opportunity.
Completion of Schedule 1 is required to identify responsibilities and the necessary consideration when carrying out a research exposure to ensure local compliance with the Ionising Radiation (Medical Exposure) Regulations 2000 (IRMER), completion is not approval for the trial to run
To obtain approval for research involving ionising radiation the following is required; IRMER sign-off
for radiation safety, SSI sign-off from Radiology for capacity base
For IRMER sign-off (PAN Trust) please go to
Head of Radiation Protection (Michael Wynn-Jones)
PI/Research Nurse to provide copies of the Protocol, Main REC form, SSI and PIS to Head of Radiation Protection
For SSI sign-off please go to
Head of Radiology PAN Trust (Andrew Prydderch)
PI to meet with Head of Radiation Protection to obtain advice on completing Schedule 1 IRMER Procedure 8
Schedule 1 IRMER procedure 8 PI to complete Part A and D
Named IRMER practitioner(s) to complete Part B http://intranet/subsites/Radiology/Homepage.htm Medical Physics Expert (MPE) to complete Part C
Completed IRMER form to be submitted to Research Governance Office
Please note SSI sign-off for radiology encompasses capacity base for nuclear medicine, radiology
and radiotherapy. This is the only sign-off required on the SSI form for these departments. 20
Days
Appendix 2; R & D Guide for IRMER Procedure 8 and Radiology Sign Off
. NB. It is important to stress that in order to minimise time delay and avoid confusion the PI should contact the Head of Radiation Protection in the first instance. The Head of Radiation Protection is the first point of contact for Medical Physics Expert (MPE) advice, however, he may refer you to other medical physics experts such as the Lead Physicist for Nuclear Medicine, Diagnostic Radiology or Radiotherapy.