Title: Obtaining NHS Permission at UCLH
SOP Number and Version: 3, V1
Effective Date: 24/02/2015
Review Date: 24/02/2018
Please check this is the latest version of the SOP on the Joint Research Office website:
www.ucl.ac.uk/jro.
Author:
Name: Suzanne Binks
Position: Quality Assurance Coordinator (Research Governance)
___________________________________
Signature
Date
Approved by:
Name: Rajinder Sidhu
Position: Director of Research Support
____________________________________
Signature
Date
Authorised by:
Name: Nick McNally
Position: Director of Research Support
_______________________________________
Signature
Date
Obtaining NHS Permission, SOP 3, V1 24/02/2015
Page 1 of 10
Revision Chronology:
Version Effective
Reason for change:
Number: date:
1
24/02/2015 Initial standardised SOP for use within UCLH.
Author:
Suzanne
Binks
ACRONYMS
ARSAC
CAG
CCTU
CI
CRF
CRN
CRO
CSP
CTIMP
DCD
IMP
IRAS
ISF
JRO
LO
LWENC
MHRA
NIHR
PI
PAF
REC
SOP
SSI
TFC
Administration of Radioactive Substances Advisory Committee
Confidentiality Advisory Group
Cancer Clinical Trials Unit
Chief Investigator
Clinical Research Facility
Clinical Research Network
Clinical Research Office
Coordinated System for Gaining NHS Permission (for all studies going through
NIHR portfolio adoption).
Clinical Trial of Investigational Medicinal Product
Divisional Clinical Director
Investigational Medicinal Products
Integrated Research Application System
Investigator Site File
Joint Research Office
Liaison Officer
Leonard Wolfson Experimental Neurology Centre
Medicines and Healthcare Products Regulatory Agency
National Institute for Health Research
Principal Investigator
Portfolio Adoption Form
Research Ethics Committee
Standard Operating Procedure
Site Specific Information
Trial Facilitation Committee
BACKGROUND
The Sponsor is responsible for the management of research studies and therefore must
ensure the appropriate governance arrangements are in place, including an favourable
ethical opinion from the REC (if applicable) and any other relevant regulatory
approvals prior to undertaking research at the Trust site. There is also a need to assess
local feasibility and to obtain local NHS Permission (R&D approval). It is a condition of
the Research Governance Framework (2nd edition, 2005) that relevant regulatory approvals
and NHS Permission are in place before conducting health and social care research at
UCLH.
PURPOSE
The SOP describes the procedure for obtaining NHS permission from the JRO prior to
recruiting participants at UCLH. As part of the Harmonisation process, one of four Trust
Obtaining NHS Permission, SOP 3, V1 24/02/2015
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Permission Centres will process and issue NHS Permission for a study to take place at
UCLH, depending on the disease area (appendix 1). Harmonisation applies to routes a. and
b. below only. There are three pathways to obtaining NHS permission at UCLH;
a. Commercially sponsored studies (Commercial Harmonisation - appendix 2).
b. Non-commercially sponsored studies proceeding through CSP (Non-commercial
Harmonisation – appendix 3).
c. Non-commercially sponsored studies not proceeding through CSP (appendix 4).
Where a study falls under the remit of the harmonisation process (routes a and b) and the
permission centre is not UCLH, the JRO will not be involved in issuing NHS Permission.
PROCEDURE
Responsible
persons
(Who?)
Actions (When? How?)
1
Creating an IRAS Account
The Sponsor representative and CI submitting an application to the REC (and other
relevant regulatory bodies) and to the JRO will require an IRAS account to be
created. The PI will also require an IRAS account to electronically sign the PI
declaration in section 23 of the SSI form.
Sponsor, CI,
PI, or
delegated
individual
Individuals registering with IRAS for the first time will need to create an account at
https://www.myresearchproject.org.uk/.
2
NIHR Portfolio Adoption
Studies funded by industry and non-commercial organisations registered as partner
organisations of the NIHR qualify for adoption onto the NIHR portfolio.
Sponsor, CI
or delegated
individual
A Portfolio Adoption Form should be submitted via IRAS for adoption onto the NIHR
portfolio. This can be generated by ticking ‘yes’ to question ‘5b’ on the project filter
questions on IRAS.
3
Required Forms for Review
IRAS will produce the necessary forms for submission to the relevant review bodies
(e.g. R&D, REC and MHRA). Not all review bodies will be relevant for every study,
and therefore it is very important to answer the filter questions at the beginning of
the IRAS dataset accurately to ensure the correct study type is identified and the
relevant form sections generated.
Sponsor, CI,
PI or
delegated
individual
4
Trial Facilitation Committee (TFC) and CRF adoption
Cancer studies must be submitted to a TFC to assess local feasibility. The
requirement for this should be confirmed by the local research team. As part of the
feasibility, a local risk assessment will be performed to highlight any issues and
consideration given to how to mitigate these risks. Clinical Research Facilities
considering studies for adoption will also have their own review committees in
place.
PI or
delegated
individual
Studies taking place in a Clinical Research Facility (CRF) must also seek
authorisation from the relevant review board for this facility.
5
Transfer of Site Specific Information (SSI) Forms
Following TFC agreement that a study can go ahead, the PI/delegated individual
should confirm this with the Sponsor and obtain timelines. The SSI should then be
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Sponsor, PI,
delegated
individual
transferred to the PI/delegate for completion of local study site details.
6
7
Authorisations
Check and send the IRAS forms to the relevant persons for authorisation (e.g. CI,
Sponsor’s representative or PI) for review and electronic authorisation.
Submitting Forms and Documentation for Review
For studies proceeding through CSP, documents should be submitted for NHS
permission through IRAS. For studies that are not proceeding through CSP,
documents should be sent directly to the JRO.
Authorisation
signatories
Sponsor or
delegated
individual
The checklist of documents that are required for the JRO to review can be found in
appendices 4 and 5 (requirements for commercial studies and non-commercial
studies respectively).
8
Contract Review
Not all studies will require a contract. Where a sponsor’s template has been
provided as part of the submission, this will be reviewed against the correct model
agreement template, and finalised ensuring that all legal requirements are in place.
The Contracts Manager will determine whether an agreement is required where a
template has not been provided by a sponsor.
JRO
Contracts
Manager
9
Costing Review
For commercially sponsored studies, the NIHR Industry costing template and
protocol will be used to ensure the study is appropriately costed. Where the study is
not commercially sponsored, the SSI form will be used to ensure adequate funding
is in place for the procedures involved.
JRO Cost
Accountant
10
Pharmacy Review
For trials including medicinal products a review will be conducted by Pharmacy.
Clinical Trial
Pharmacist
11
Radiology Review
For trials involving imaging procedures, a review will be conducted by Radiology.
Radiology
Coordinator
12
Divisional Clinical Director Review
Authorisation will be sought from the Clinical Director of the division in which the
research is taking place.
Divisional
Clinical
Director
13
Research Passport
Where researchers without a UCLH contract are coming onto UCLH premises to
conduct research, a Letter of Access or Honorary Contract will need to be obtained
from the JRO. Please refer to the guidance on the website.
Researcher,
JRO
Administrator
14
ARSAC Research Licence
Where nuclear medicine procedures include radiation doses over and above
standard practice as mandated within a protocol, an ARSAC licence will be
required. It is important to liaise with the Nuclear Medicine Department who will
coordinate the ARSAC application.
PI or
delegated
individual,
Nuclear
Medicine
15
Issuing NHS Permission
Once all the above steps have been completed, NHS permission can be issued. A
letter will be sent via email to the PI for the study, listing the conditions of approval.
Sponsor or
Delegated
Individual
Sponsors should not circulate an ‘open to recruitment’ letter and no participant
documentation should be handed to potential participants prior to receiving this
letter.
16
Starting the Study
Upon receipt of a Trust NHS permission letter, a member of the research team may
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Delegated
individual
need to ensure that all necessary approvals and actions have been undertaken. and
confirm with Pharmacy that the study (if applicable) has been set-up as a validated
protocol on Chemo-care. Once confirmed, the ‘open to recruitment’ letter should be
circulated to all relevant service department staff, Investigators and R&D.
REFERENCES
Health Research Authority
http://www.hra.nhs.uk/research-community/
IRAS
https://www.myresearchproject.org.uk/Signin.aspx
NIHR Clinical Research Network Portfolio
http://www.crn.nihr.ac.uk/can-help/funders-academics/nihrcrn-portfolio/
APPENDICES
Appendix 1: Permission centres and their disease areas
University College London Hospitals NHS
Foundation Trust (UCLH)
Cancer
Non-malignant Haematology
Nervous System Disorders
Dementias and Neurodegenerative Disorders
Stroke
Diabetes
Endocrine and Metabolic
Ophthalmology
Great Ormond Street Hospital NHS
Foundation Trust (GOSH)
Paediatrics
Ear, Nose and Throat
Reproductive Health and Childbirth
Genetics
Barts Health NHS Trust (Barts)
Gastroenterology
Hepatology (non-commercial studies)
Surgery, Critical Care, Accidents and Aesthetics
Musculoskeletal and Immunology and
Inflammation
Dermatology
Infectious Diseases and Microbiology (noncommercial studies)
Renal and Urology
Respiratory (non-commercial)
Cardiovascular
North Central London Research Consortium
(NoCLoR)
Public Health Research
Health Services Research
Oral and Dental
Mental Health
Primary Care
Age and Ageing
Respiratory (commercial studies)
Infectious Diseases and Microbiology (commercial
studies)
Hepatology (commercial studies)
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Appendix 2: Commercial Harmonisation Pathway
UCLH PERMISSION CENTRE (PC) notified of new study via email
(from CSP team, study team, sponsor or CRO)
Study wide
/Local checks
Study registered on internal database and allocated to a Liaison
Officer (LO)
Portfolio
adoption form
(PAF) list North
Thames as
Lead LCRN
LO sends email to CI/PI/sponsor introducing the harmonisation
process and initiates all applicable internal review processes:







LO conducts
study wide
review
Costing review
Contract review
Pharmacy review (CTIMP studies only)
Imaging review (studies involving ionising radiation)
Obtain Divisional Clinical Director (DCD) authorisation
Confirm review and adoption of study with CRF/TFC
Local SSI
submission
submitted by
study team
Contract finalised. LO requests
partially signed agreements
from study sponsor
LO conducts
local checks
LO receives partially signed
contract and obtains internal
signatures
Contracts fully signed
Pharmacy, imaging and DCD
authorisation obtained
Study wide (if applicable) and
local checks completed
LO request Portfolio Database Administrator (PDA) to grant NHS
Permission
PDA issues NHS permission letter to PI and sends contract via
email.
LO returns hard copies of the contract to the sponsor/study
team.
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Appendix 3: Non-commercial Harmonisation Pathway
Permission Centre (PC) is notified about the study at
PAF submission stage.
Permission Centre initiates costing and contract
reviews and completes the Study Wide review
Cost Accountant completes the
costing and sends to the Divisional
Portfolio Officer (DPO) and
Contracts Manager
DPO initiates all applicable internal review processes:
Contract manager
completes the
Contract Review
and sends to PI and
Sponsor for review
and signatures
once costing is
confirmed.
 Imaging review (studies involving ionising radiation)
 Pharmacy review (CTIMPs only)
 Obtain Divisional Clinical Director (DCD)
authorisation
 Confirm review and adoption of study with CRF/TFC
 Research Passport application for letter of access or
honorary contract
Study team completes
SSI submission.
Divisional Portfolio
Officer (DPO)
validates and informs
the study team of the
outcome.
Portfolio Adoption
Team (PAF) Confirms
Portfolio Eligibility
If North Thames Lead
CRN, Permission
Centre completes
Study Wide Review
and requests Quality
Check from LCRN
Final NHS Permission
Internal reviews
complete and
confirmed
Letter of access/
honorary contract ready
for issue
The Divisional Portfolio Officer instructs Permission
Centre to issue NHS Permission letter.
Receipt of fully
signed contracts
Permission Centre issues NHS permission letter to PI and sends contract via email.
Letter of access/honorary contract is issued to research team member(s).
Hard copies of the contract sent to the sponsor/study team
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 Divisional Clinical
Director (DCD)
authorisation
 Pharmacy
authorisation
 Radiology
authorisation
 Costing review
complete
 Contract fully
signed
 Study Wide
review complete
 Local Review
Completed
 Portfolio Eligibility
confirmed
Appendix 4: Non-commercial Non-harmonisation Pathway
Document set for a new study received by JRO through
R&D inbox: randd@uclh.nhs.uk (see submission checklists
in appendices 4 and 5)
Study is registered on R&D internal database and allocated
to a Portfolio Coordinator (PC)
The PC begins local review of the study and initiates all
applicable internal review processes:








Costing review
Contract review
Pharmacy review (CTIMP studies only)
Imaging review (studies involving ionising radiation)
Divisional Clinical Director (DCD) authorisation
Research Passport application for letter of access or
honorary contract
Confirm review and adoption of study with CRF/TFC
Documentation checked for completeness
Contract/costing
finalised. Partially signed
agreements requested
from the counter party
Contracts received and
signed by UCLH
signatory
Internal reviews
complete and
confirmed
Letter of access/
honorary contract
ready for issue
NHS Permission letter is issued to the Principal Investigator via email.
Letter of access/honorary contract is issued to research team member(s).
Hard copies of contracts sent to counter party/study team.
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Appendix 5: Commercial study submission checklist
For studies proceeding through CSP, submit via IRAS.
For studies not proceeding through CSP, submit via harmonis@uclh.nhs.uk
Item
Documents
Requirements
IRAS Forms
1.
R&D Form
2.
REC form
3.
SSI form
Fully signed and dated by the CI and Sponsor (and any other
signatories)
Optional – fully signed and dated by the CI and Sponsor (and any
other signatories)
Fully signed and dated by the PI
Supporting study documents
4.
Protocol
Latest REC approved version
5.
REC approval
6.
Participant Information Sheet
All the correspondence related to REC, this includes provisional
approvals, response to further clarification & any amendments
made since the original approval and related correspondence
Latest REC approved version localised & on local site headed paper
7.
Consent Forms
Latest REC approved version localised & on local site headed paper
8.
GP Information sheet/letter
9.
Advertisement & Invitation
Letter
13. SmPC
(If applicable) Latest REC approved version localised & on local site
headed paper
(If applicable) Latest REC approved version localised & on local site
headed paper e.g. Participant invitation letters, posters, newspaper,
website adverts, diary care, questionnaires etc.
(If applicable) All correspondence related to MHRA, this includes
Objections and response to further clarification and any
amendments made since the original approval/objection
Applicable where exposure to radioactive material is involved that is
in addition to routine care
Latest REC approved version - applicable for device trials and
CTIMPs only
Latest REC approved version - applicable for trials involving drugs
14. Evidence of valid Insurance
Fully signed and dated
15. Contract Template
As agreed for harmonisation studies i.e. ABPI 2011 mCTA
16. Costing Template
Completed NIHR industry costing template
10. MHRA approval
11. ARSAC Certificate
12. Investigator’s Brochure
Additional Supporting documents
Most up to date version. Please DO NOT include personal details on
17. CV for Principal Investigator
18. CVs of all members of the
local research team
19. GCP Certificates for all
members of the local team (as
listed on the SSI form)
20. Other Regulatory approvals
21. Research Passports
22.
Anticipated site initiation date
the CV e.g. home address, date of birth
For those listed on SSI form. Most up to date. DO NOT include
personal home addresses & details on the CV’s
Applicable for CTIMPs only. Please ensure this is no more than 2
years old.
Any other e.g. CAG, GTAG, etc. and all correspondence
Applicable where members of the local research team are not
directly employed by the local research site.
Optional: This information will help us to work towards a deadline
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Appendix 6: Non-commercial study submission checklist
For studies proceeding through CSP, submit via IRAS.
For studies not proceeding through CSP, submit via randd@uclh.nhs.uk
Item
Documents
Requirements
IRAS Forms
1.
R&D Form
Fully signed and dated by the CI and Sponsor (and any other signatories)
2.
REC form
3.
SSI form
Optional – fully signed and dated by the CI and Sponsor (and any other
signatories)
Fully signed and dated by the PI
4.
Portfolio CSP Reference No
Applicable if the study is going through the NIHR CSP Portfolio route
5.
Protocol
Latest REC approved version
6.
REC approval
7.
Participant Information Sheet
All the correspondence related to REC, this includes provisional
approvals, response to further clarification & any amendments made
since the original approval and related correspondence
Latest REC approved version localised & on local site headed paper
8.
Consent Forms
Latest REC approved version localised & on local site headed paper
9.
GP Information sheet/letter
(If applicable) Latest REC approved version localised & on local site
headed paper
(If applicable) Latest REC approved version localised & on local site
headed paper e.g. Participant invitation letters, posters, newspaper,
website adverts, diary care, questionnaires etc.
(If applicable) All correspondence related to MHRA, this includes
Objections and response to further clarification and any amendments
made since the original approval/objection
Applicable where exposure to radioactive material is involved that is in
addition to routine care
Latest REC approved version - applicable for device studies and CTIMPs
only
Latest REC approved version - applicable for trials involving drugs only
Supporting study documents
10. Advertisement & Invitation
Letter
11. MHRA approval
12. ARSAC Certificate
13. Investigator’s Brochure
14. SmPC
15. Evidence of valid Insurance
Fully signed and dated
16. Contract Template
(If applicable) e.g. mNCA, MTA, DTA
17. Funding or Grant award letter
Fully signed and dated
Additional Supporting documents
18. CV for Principal Investigator
19. CVs of all members of the
local research team
20. GCP Certificates for all
members of the local team (as
listed on the SSI form)
21. Other Regulatory approvals
Most up to date version. Please DO NOT include personal details on the
CV e.g. home address, date of birth
For those listed on SSI form. Most up to date. DO NOT include personal
home addresses & details on the CV’s
Applicable for CTIMPs only. Please ensure this is no more than 2 years
old.
Any other e.g. CAG, GTAC, etc. and all correspondence
22. Research Passports
Applicable where members of the local research team are not directly
employed by the local research site.
23. Anticipated site initiation date
Optional: This information will help us to work towards a deadline
Obtaining NHS Permission, SOP 3, V1 24/02/2015
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