Complete IRAS to NHS Permission Granted

1
Set up account on IRAS website Using filter
questions as appropriate generate and complete
data set for project for guidance visit Link to
Help page.
Complete IRAS data set
1
Complete IRAS to NHS Permission Granted
If you would like your project to be considered
for adoption onto the NIHR portfolio, complete
and submit a PAF. NB This is the only opportunity
to do this. See this link for portfolio
eligibility criteria. It is better to apply and
be rejected than fail to apply.
See link for checklists
Complete checklist, uploading documents as
requested depending on study type
2
IRAS form will allow you to generate data
sets/forms for MHRA, RD and Ethics applications.
Submit PAF (NIHR Portfolio only)
3
The owner of the IRAS form must generate SSI
forms.
SSI forms are transferred to sites for completion.
Submit data sets to authorising organisations
(except Site NHS Permission)
4
For CSP studies, SSI forms are submitted by the
main site transfer the completed form to main
site.
5
Generate SSI Forms
Explicit support of the study must be gained from
departments whose support is needed. See here for
proformas.
Submit SSI form with all signed documents. See
our website for further information.
Complete SSI Forms
Complete SSI Forms
6
The main site submits completed SSI form through
IRAS to CSP with associated documents
Return SSI Forms to main site
7
Gain local approvals from support departments
Gain local approvals from support departments
8
8
Submit SSI form with all required documents
(valid RD application pack
Main site submits SSI form with local documents
through CSP
9
10
CSP Studies
Non- CSP Studies
RMF begins the Research Support Services risk
assessment process. Checks around the following
are done Application quality, suitability for UH
Bristol sponsorship, complexity/organisational
responsibility, IMP, consent, study type, data
and tissue, research team, recruitment and
retention, finance, resource, other relating to
study, regulatory and contractual requirements.
Your Research Management Facilitator will take
the project through approval.
Register the project on e-dge if not already done
Allocate RMF to project
11
Governance checks commenced
Start RSS risk assessment
12
Ensure standard wording incorporated, with all
required documents
Discuss with researcher New application OR
Revisions/ additional information
Has feasibility with support departments and
trial unit been discussed?
What are the funding arrangements?
Approval may be issued pending finalising some
items, like for research passports or contracts.
Ensure these are complete.
Monitoring and recruitment plan developed and
agreed
Approval issued by email
13
Ensure all conditions of approval are met
Start recruiting