Coordinated System for gaining
NHS Permission
Streamlining the NHS Permissions process
The National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permission (CSP)
standardises and streamlines the process of gaining NHS Permission (also known as R&D approval) for
commercial and non-commercial research in England, which is required before any clinical research in the
NHS can commence. CSP is the NIHR Clinical Research Network’s recommended route for commercial
clinical research studies in England to gain their NHS Permission(s).
CSP is accessible via the Integrated Research Application System (IRAS), the system used to apply for
the permission and approvals for a research study. IRAS enables information to be entered once into
an integrated data set, which then populates the separate application forms. CSP is designed to run in
parallel to your applications made through IRAS to other regulatory bodies such as the NHS Research
Ethics Committee (REC), and provides an efficient process for gaining NHS Permission to make setting up
commercial research in the NHS faster and easier.
Current CSP target timelines are:
•
80% of studies obtaining NHS Permission through CSP within 40 calendar days from receipt of a valid
R&D application
In addition, local sites have internal process improvement targets of:
•
•
15 calendar days from receipt of a valid R&D submission to completion of study-wide review
15 calendar days from receipt of a valid SSI submission to NHS Permission issued at an NHS
organisation
It is important to note that the use of CSP relates solely to the processing of information for R&D office
purposes. It does not replace the Sponsor’s responsibility to provide the current versions of documents to
research teams.
Using CSP to apply for NHS Permission
The steps to gain NHS Permission using CSP are summarised in the flowchart overleaf and detailed further
below:
STEP 1 - PAF SUBMISSION
The first step in the CSP process is to complete a Portfolio Application Form (PAF) to enable your study to
be registered for Network support even if your study has already been deemed eligible for the Portfolio. A
PAF is generated in the Project Forms section of IRAS when question 5b in the Project Filter is answered
with ‘yes’. The PAF is completed and electronically submitted through IRAS to CSP.
Selecting your Lead CLRN
When submitting your PAF, you will be asked to select a Lead Comprehensive Local Research Network
(CLRN) for your study, which will act as the main point of contact in England for your study. This is usually
determined by the location of the lead NHS R&D office, which may also be the location of the Chief
Investigator (CI). However, it may be more appropriate to choose a Lead CLRN where the Study
Coordinator is located, for example.
STEP 2 - R&D SUBMISSION
Once the PAF has been validated you will receive an email requesting the electronic submission of your
R&D application. Documents to support this application should be attached to the IRAS R&D Form
Checklist for your study, and these will be submitted electronically to CSP along with the form. This R&D
Checklist also includes documents required for a submission to NHS REC; this ensures consistency
between information reviewed by both the NHS REC and R&D departments.
When submitting your initial R&D application through IRAS to CSP you may not have all of the documents
detailed at the end of the R&D Checklist, such as the NHS REC Favourable Opinion letter. Once you have
received these documents they should be attached to the R&D Checklist in IRAS and submitted to CSP as
a document only submission. If any documents forming part of the initial submission package are not
applicable, please provide a comment on the R&D Checklist. Following NHS REC approval, any new
versions of documents should be supplied and must match the version numbers listed in the NHS REC
Favourable Opinion letter.
Receipt of your R&D application will enable the Lead CLRN to begin the study-wide governance review.
STEP 3 - SSI SUBMISSION
Once the R&D application has been validated you will be asked to electronically submit your Site Specific
Information (SSI) application(s), which are submitted by the Principal Investigator (PI)/Study Coordinator
for each NHS organisation participating in the study. A valid application consists of the form and associated
documents required for the submission as detailed within the IRAS SSI Form Checklist. The application will
be validated by the CLRN Research Management & Governance staff at each NHS organisation, who will
then commence the local governance review and work with the PI and/or research team to resolve any
issues that may arise.
STEP 4 - NHS PERMISSION LETTER ISSUED
When your study has been deemed eligible for the Clinical Research Network Portfolio, the study-wide
governance review has been completed and the NHS organisation has completed its local governance
review, a Governance Report is generated. This provides the evidence that all governance criteria have
been reviewed and is used to highlight any identified risks or issues. The NHS organisation will then
issue an NHS Permission Letter to the PI, copied to the Chief Investigator/Study Coordinator. It is only upon
receipt of this permission letter that the study can begin at that NHS organisation.
Gaining NHS Permission for commercial studies using NIHR CSP
For general process advice contact the Industry Information Centre Team.
IRAS
www.myresearchproject.org.uk
Contact: IRAS Helpdesk helpdesk@infonetica.net
or CSP Helpdesk crncc.csp@nihr.ac.uk
CREATE PROJECT DATASET
1. Submit Portfolio Application Form
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Submit
required forms
to regulatory
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NHS REC
2. Submit R&D Application
A B C
Network eligibility
ideally should be
initiated before IRAS
submission
3. Submit SSI Application
Regulatory bodies grant approvals
Submit to Network:
Coordinated System
for gaining NHS
Permission (CSP)
1. Portfolio
Application Form
Upon receipt of valid
form, confirmation
will be provided that
the R&D application
can be submitted.
•
•
2. R&D Application
Upon receipt of valid
R&D Form, Checklist
and documents, Lead
CLRN will undertake
study-wide
governance review
and share across all
participating sites.
3. SSI Application
Upon receipt of valid
SSI Form and
documents,
participating
CLRN(s) will
undertake local
governance review.
Study protocol
Industry
submission
Negotiate and agree
contract and costs
with support from
Network
Draft relevant:
For each participating site: once the study-wide and local governance
reviews are complete and Portfolio eligibility has been confirmed, the
NHS organisation will issue an NHS permission letter.
•
•
Industry Costing
Template
Model agreement
Research can start at a participating site upon receipt of the NHS permission letter from that NHS organisation.
www.crncc.nihr.ac.uk/csp
Submitting an amendment
The Lead CLRN is available to offer advice on preparing an amendment and the associated documents,
prior to it being submitted. Amendment documents should be uploaded the Amendment section of the IRAS
R&D Form and submitted to the Lead CLRN as either a document only submission or a full R&D submission if changes to the R&D form have been made. You should submit your amendment to CSP in parallel to
any regulatory bodies so that the 35 day period to confirm continuation of NHS Permission, if
applicable for the amendment type, does not delay the implementation of the amendment. The
amendments will be categorised upon receipt by the Lead CLRN as either:
a) notifiable - those that require a 35 day period during which an objection can be raised and therefore need
to be notified to all participating sites; or
b) non-notifiable - those that may be implemented by the Sponsor without waiting for the 35 days to elapse.
Participating sites have no action to take when the amendment is non-notifiable.
Examples of substantial and non-substantial amendments can be found on the NRES website at
http://www.nres.nhs.uk/applications/after-ethical-review/notification-of-amendments/examples-ofsubstantial-and-non-substantial-amendments/. For all studies, responsibility for determining whether an
amendment is substantial or non-substantial lies with the Sponsor.
UK wide studies
For studies involving more than one of the devolved administrations (England, Northern Ireland, Scotland
and Wales) IRAS requires the selection of a Lead Administration. This is usually determined by
location of the lead NHS R&D office, which may also be the location of the CI. If the study is led from
England, it will be possible to electronically submit your applications via IRAS to CSP. Where another UK
nation is leading the study, electronic submissions are currently not enabled. In these circumstances, the
R&D application should be emailed to the Lead Administration’s coordinating centre. The Lead
Administration takes responsibility for notifying the other administrations participating in the study so that
they can manually commence their national approval processes (eg CSP for England). This avoids multiple
submissions to each devolved administration by the Sponsor.
Contact us
You can access CSP specific information and support online at:
w: www.crncc.nihr.ac.uk/csp
t: 0113 343 2314
e: crncc.csp@nihr.ac.uk
The Industry pages of our website provides information on other Clinical Research Network support
offerings:
w: www.supportmystudy.nihr.ac.uk
If you have any questions or require further information, please contact our Industry Information Centre:
t: 0113 34 34 555
e: supportmystudy@nihr.ac.uk