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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

SOP No. 13 Authorised Signatory - ulh.nhs.uk · SOP No. 13 Authorised Signatory SOP Title Authorised Signatory ... (TBC) 4. Services to be provided by the General Surgery Business

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Text of SOP No. 13 Authorised Signatory - ulh.nhs.uk · SOP No. 13 Authorised Signatory SOP Title...

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 Investigators (PI) or Chief Investigators (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)

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4108962http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4108962http://www.crncc.nihr.ac.uk/Resources/NIHR%20CRN%20CC/CSP/Documents/NIHR%20CSP%20Operating%20Manual%20v5_1%2020%2007%202011.pdfhttp://www.crncc.nihr.ac.uk/Resources/NIHR%20CRN%20CC/CSP/Documents/NIHR%20CSP%20Operating%20Manual%20v5_1%2020%2007%202011.pdfhttp://www.legislation.gov.uk/uksi/2004/1031/contents/made

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 Childrens 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 Childrens 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 SOPs can be located on the Research and Developments shared file and a hard copy of all SOPs are kept in the Trial Master File

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4108962http://www.crncc.nihr.ac.uk/Resources/NIHR%20CRN%20CC/CSP/Documents/NIHR%20CSP%20Operating%20Manual%20v5_1%2020%2007%202011.pdfhttp://www.crncc.nihr.ac.uk/Resources/NIHR%20CRN%20CC/CSP/Documents/NIHR%20CSP%20Operating%20Manual%20v5_1%2020%2007%202011.pdfhttp://www.legislation.gov.uk/uksi/2004/1031/contents/made

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.

http://intranet/subsites/Radiology/Homepage.htm