Procedure for R&D Approval within SLaM
Researcher:
Is study eligible for UKCRN Portfolio?
http://www.ukcrn.org.uk/index/clinical/portfolio_new/P_eligibility.html
If unsure contact R&D Office for advice
Yes
Use CSP system (IRAS) for
approval (see over). Contact
R&D Office for advice.
No
Researcher:
Submits paperwork to R&D Office
 R&D Approval Form & SSI (IRAS)
 Electronic copy of protocol if study is a clinical trial of an investigational medicinal product or involves a drug or
requires peer review
 R&D Cover Sheet
 Honorary Contracts (if already in place)
 Research Passport (if already completed)
 Ethics & MHRA Approval (where required)
 Evidence of additional training if CTIMP is also required
Access to ICT
Required
R&D Office:
Reviews Paperwork to confirm application complete and checks:
 if Access required to Trust ICT systems
 Honorary Research Contracts/letter of access required (HRC/LOA)
HRC/LOA required
R&D Office:
Completes Calidcott Guardian Approval Form and
sends electronically to Caldicott Guardian
(information taken from ethics/R&D Forms)
R&D Office:
Sends Research Passport Pack to Researcher for
completion and return to the R&D Office
Caldicott Guardian:
Reviews and approves access and returns completed
form to R&D Office
R&D Office:
Completes all Governance Checks on the project (including
ethics/MHRA approval) adds information to R&D Database and
HRC/LOA spreadsheet and issues R&D Approval.
R&D Office:
Scans and e-mails ICT Approval forms to ICT for
processing
R&D Office:
Issues Honorary Research Contract/Letter of Access
and ID Badge request form for researcher
CI decides study to be
considered for portfolio
adoption
Study will not be processed
through CSP. Usual
process of application for
approval followed
NO
YES
CI or delegee logs onto IRAS
Click on Create New Project
Complete IRAS filter questions as follows:
Q3a – England selected as where lead R&D office located to enable Q5a
Q5a - Select Yes for application to be processed through NIHR CSP
SLaM Lead NHS R&D Contact
Jenny Liebscher, South London and
Maudsley NHS Foundation Trust,
R&D Governance and Delivery
Manager, R&D Office (PO05),
Institute of Psychiatry, De
Crespigny Park, Denmark Hill,
London, SE5 8AZ.
Jennifer.liebscher@kcl.ac.uk
Telephone 020 7838 0251, Fax 020
7848 0147
N.B. The Portfolio Adoption Form
(PAF) has been re-named as the
CSP application form
Complete rest of Filter
Before submitting any applications, Portfolio Adoption Form (PAF) must
be completed – link located in Project Forms list on left hand side of
Navigation Page.
Complete all data fields on PAF, including details of Lead NHS R&D
contact (CSP Lead for Trust where CI based and/or lead site where
research will be undertaken).
On Navigation Page select Submission tab.
Click on Submit button to electronically submit PAF to NIHR Coordinated
System
The current status of the application will be displayed on this tab
Timelines for Adoption
PAF sent to Portfolio Team at UKCRN for review
The Portfolio Team have 2 working days to
decide if studies are potentially eligible or
not eligible.
The Portfolio Team then have a further 30
days to review studies to decide if potentially
eligible studies are to be adopted.
Study adopted onto
portfolio
Studies that are not adopted will be processed
through CSP until the point at which they
decide that the study is not eligible. At this
point, the usual process for gaining permission
should be followed.
NO
POTENTIALLY
PAF sent to CSPU for uploading to CSP ReDA *
KEY
* CSP ReDA is the system which tracks the CSP process
CSPU – CSP Unit, part of UKCRN, based in London
CLRN – Comprehensive Local Research Network
Study not processed
though CSP
Study potentially eligible for adoption onto portfolio
CSPU allocate study to a CLRN to act as Lead for the study – usually where CI
based or primary/lead research site. CLRN notified via CSP ReDA
CI or designee completes NHS R&D Form in IRAS:
CI adds NHS SSI Form for study, creates copies for participating sites and transfers to PIs (see IRAS guidelines).
Click on link to NHS R&D Form on Project Forms list on left hand side of Navigation Page.
PI or designee completes remaining data fields on NHS SSI Form in IRAS (see IRAS guidelines).
Complete all required data fields.
PI clicks on Submission tab with NHS SSI Form highlighted.
Click on Submission tab
PI selects local CLRN name (which covers the trust where the research will take place) from the drop down list.
Click on Submit button to send form electronically to UKCRN
Click on Submit button to send form electronically to UKCRN.
Lead CLRN notified of NHS R&D Form submission via CSP ReDA
Lead CLRN contacts CI to ensure funding approved.
Lead CLRN checks NHS R&D Form to ensure complete and filters correct
(i.e. all appropriate fields present).
CLRN notified of SSI submission via CSP ReDA
CI notified of
valid application
by email from
CSP ReDA
CLRN checks SSI for completeness and
notifies trust of SSI submission
PI notified of
valid application
by email from
CSP ReDA
PI submits all supporting documentation needed for approval to CLRN^
CI submits all supporting documentation needed for approval to Lead CLRN^
Trust undertakes local governance checks
Global checks undertaken by CSPU or Lead CLRN
All checks completed
CSPU or Lead CLRN perform Quality Assurance checks on governance checks
Target 7 days for
QA checks
CSPU/CLRN sign off and trust notified that can print off Governance Report and submit with other required documents to local Permission Signatory for approval and sign off
Target 21 days
for sign off
PI and CI informed by email alert from CSP ReDA that study approved at trust