New UK process for handling amendments to NIHR CSP studies

NIHR CSP Guide for Researchers
New UK process for
handling amendments
to NIHR CSP studies
A revised UK study amendment handling
process is being introduced across the UK in
November 2014. The purpose is to reduce the
number of study amendments that NHS
organisations need to review for continuing
NHS Permission, thereby speeding up the
timelines of amendments that do need review.
The process is recommended to run in parallel
to regulatory review and harmonises across all
four UK nations, the principle of a 35 calendar
day default approval of amendments for NHS
organisations and introduces the categorisation
of amendments into Category A, B, or C. The
new process will benefit both researchers and
NHS organisations by reducing overprocessing and minimising unnecessary delays
to the implementation of Category C
amendments.
CATEGORY A
CATEGORY B
CATEGORY C
• An amendment that
impacts or affects ALL
participating NHS
organisations, therefore
needs to be considered
and may need change
control actions
• An amendment that
impacts or affects
SPECIFIC participating
NHS organisations. Only
at these organisations
does it need to be
considered and take any
change control actions
required
• An amendment that has
no impact on NHS
organisations hence
does not require
management or
oversight. R&D do not
need to be notified of
such amendments,
however will have
access to all documents
within their CSP
Module.
 Subject to
regulatory
approval,
Category C
amendments can
be implemented
immediately.
For Category A and B amendments, NHS
Organisations have a maximum of 35 days to
raise an objection otherwise the amendment
can be implemented at the end of the 35 day
period. They are encouraged to implement
earlier where possible.
What must I do?
 Amendments should be submitted to CSP
electronically through IRAS for England-led
studies. We strongly recommend that this
happens in parallel to the applications to
other regulators.
 Where the study is led by another Devolved
Administration, the amendment should be
sent to the Lead Nation contact who will
liaise with England.
The Sponsor/CI is responsible for providing
details of the amendment, including copies
of revised documents, to all participating
Investigators and study teams.
What happens once I submit my
application?
Key principles
The Lead Local Clinical Research Network
 Applies to both substantial and nonsubstantial amendments1 as categorised by
the Sponsor.
(LCRN) will confirm:
 Studies must have gained approval through
CSP.
 The 35 day period starts on receipt of a full
amendment submission (i.e. amendment
form, letter and revised documents).
 Where required, regulatory approval must
be in place before an amendment can be
implemented. The only exception to this rule
is an urgent safety measure.
1
As defined by REC, examples of substantial and nonsubstantial amendments can be found on the HRA
website.
November, 2014



whether the submission is complete
whether the amendment is Category A,
Category B or Category C
the implementation date.
Details of the amendment will be available to
the participating R&D offices through CSP,
where necessary for impact review and
contract revision as required (agreement of
which should not delay implementation).
Your Lead LCRN (see website) can offer advice on
preparing and submitting amendments. Further
guidance is also available from NIHR CRN or
specifically for commercial companies via our
‘Support My Study’ service.
Submitting your amendment in IRAS
1. Amendments must be submitted
electronically through IRAS.
2. To submit an amendment to CSP, go to the
checklist tab on the R&D form.
3. Amendment documents should be attached
to the relevant rows of the IRAS checklist. You must ensure the correct document categories
are selected.
For substantial amendments
 You must attach both the signed PDF
and XML version of the Notice of
Substantial Amendment Form.
For non-substantial
 Attach PDF under the non-substantial amendment category.
Other supporting documents
 Attach to the checklist specifying the correct
document category.
4. Regulatory approvals should be uploaded to the
checklist and submitted as and when these are
received.
5. To submit the amendment to CSP (including
regulatory approvals once received) go to the
e-submission tab on the R&D form.
6. Select your Lead LCRN from the drop-down list.
7. The submission can be made as either a ‘document
only submission’ (NB, this will not include the revised application form) or an ‘R&D
application e-submission’ (i.e. includes both the revised application form and documents
added to the checklist)’. Changes to the SSI form and/or local supporting documents must be
submitted through the SSI submission tab.
You don’t need to update the IRAS data set every time. On some occasions, in addition to submitting
the amendment form/letter and supporting documents, it will be necessary to submit a revised
application form, please use the table of examples below as a guide.
Revised R&D submission
with signatures needed
Revised R&D submission
needed without signatures
Revised SSI submission
with signatures needed
Document only
submission
• If the amendment alters
the IRAS project filter
settings enabling
additional sections of the
form (e.g. use of ionising
radiation and/or collection
or storage of tissue
where previously there
was none).
• To add a new site to Part
C, you will need to submit
the revised form as part
of your amendment, but
there is no need to have
the form re-signed.
• If the PI changes and the
original SSI form required
an electronic
authorisation or
signature.
• Change relates to the
content of supporting
documents only.
• Providing copies of
regulatory approvals
received after submission
of the amendment.