V10 – 29/07/2015
South London & Maudsley NHS Foundation Trust
R&D Approval Cover Sheet
Please refer to guidance notes before completing this form
Link to guidance notes
1. SLaM investigator: (as it appears on NRES/IRAS forms – this is where approval letter will be sent)
Full Name:
2. Project title: (as it appears on other documentation eg IRAS forms)
3. Ethics Reference (where available)
4. Project type
Type of Project
Tick all
that
apply
a) Externally funded
(Non-commercial funding body – e.g. Charity)
Further instructions
Funders Name
IoPPN Grant Code
b) Commercial Study
(company is sponsor, responsible for
protocol, retains Intellectual Property/
Publication rights)
c) Clinical Trial of an Investigational Medicinal
Product (CTIMP) or study involving a drug
d) Student
Please contact the R&D Office
Please contact the R&D Office as a risk
assessment will be required.
Student name (if different from above)
5. SLaM Clinical Academic Group (CAG) involvement & approval
Please tick all SLaM CAGs likely to be involved in the research project. Please send a brief e-mail to
each CAG director including a short outline of your study. Details are in the guidance notes attached to
this form.
Please attach each CAG director’s e-mail response to this cover sheet and submit with your
application.
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SLaM CAG
Tick those that apply
Child and Adolescent Mental Health Services
Psychosis
Behavioural and Developmental Psychiatry
Psychological Medicine
Mood, Anxiety and Personality
Addictions
Mental Health of Older Adults and Dementia
6. Recruitment Information
Please provide the estimated date that you will recruit your first participant within SLaM (please see the
guidance notes for why we need this information).
Estimated date of first patient recruited in SLaM
7. Pharmacy Arrangements
If your project involves the dispensing of medication please list which Pharmacy(ies) will be involved in
the dispensing. Please send a brief e-mail to each pharmacy including a short outline of your study.
Please attach each pharmacy(ies) e-mail response to this cover sheet and submit with your
application.
Site
Pharmacist Involved
8. Human Tissue (IoPPN Staff/Students only)
If your project involves the use/storage of Human Tissue this is now regulated by the Human Tissue
Authority. Where the study is being run within Institute of Psychiatry, KCL there is a Human Tissue
Licence in place to cover this activity; however a record of all tissue needs to be retained by the
organisation. Please ensure that you have contacted the relevant person from the grid below and give
them details of your study. Please attach an e-mail confirmation to this cover sheet and submit with
you application.
Named
Contact
Claire
Troakes
Tissue Type
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e-mail address
Claire.troakes@kcl.ac.uk
9. Access to SLaM IT Systems/Case Notes
SLaM System & Description
Access required for
(name of staff)
SLaMnet - The Trust Intranet
Includes service directories, policies, discussion forums, access
to reporting facilities and PJS, News, events diaries etc
PJS - Electronic Patient Journey System
Holds all clinical records for patients including, demographics,
referral/movements, assessments, care plans, events,
medication and risks
IRS - Trust Data warehouse and reporting suite
Secure site consists of automatically refreshed patient activity
workforce and financial reports (either summary or detailed).
Prior notification is required of the records needing to be
accessed
10. Clinical trials / interventions studies –requirements for recording research involvement in the
SLaM patient health record:
Where the study is a clinical trial/interventional study and as such affects a patient’s clinical care, it is a
Trust requirement to ensure that the patient’s participation in the study is noted in the patient’s health
record, and include a copy of the patient’s consent form in the record. This is to ensure that information
about patients’ involvement in clinical trials can be accessed at a later date, for example in the event of a
serious incident investigation.
This can either be done by the research team or by the patients care co-ordinator or clinical team, but
please take this requirement into account when organising your study within SLaM.
Is this an interventional study Y/N
If yes, please give details of how the involvement
of SLaM patients in the study will be recorded on
epjs and who will do this
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SLaM R&D submission process:
If your study is on the NIHR portfolio and the R&D approvals are being processed via NIHR CSP, please
contact Jenny Liebscher, SLaM R&D Governance Manager for details on the SLaM submission process.
Jennifer.liebscher@kcl.ac.uk 020 7848 0251
For all other non-portfolio studies please complete and return this form together with the documents listed below
to your SLaM R&D governance reviewer (contact details are at the end of this page). If you do not know who
your R&D reviewer is please contact Jenny Liebscher.
REC and R&D processes are to done in parallel where possible (Method A)
Method A: Please send the R&D submission documents below in two stages.
Stage 1:
Date
Received
Office
As soon
as youStamp
receive(R&D
the first
REC Use
letterOnly)
inviting you to the REC meeting please send us::

IRAS NHS R&D Form with all declarations signed

Protocol (as submitted to ethics)

Draft IRAS NHS SSI Form for SLaM. To create this, go into your project area in IRAS, then into the
NHS R&D form, and above the navigate section is the option to add an NHS SSI form. Please leave Q23
blank, the R&D office will contact you to discuss the local set up requirements of the study with you and you
can then complete this section with details of your R&D contact and submit the signed SSI form to us formally

SLaM R&D Approval cover sheet

Where your study involved the administration of a substance (whether or not it is a Clinical Trial of an
Investigational Medicinal Product (CTIMP) we will request your protocol to send for risk assessment (for
KCL/SLaM sponsored studies this will have been done by us at an earlier stage).
Stage 2 (as and when you receive them):

Relevant CAG authorisations (e-mail of approval when you receive it)

A copy of all correspondence with the Ethics Committee, and the final REC approved documents as
listed on the REC approval letter. It’s the responsibility of the CI to check the version numbers and dates of
the documents listed in the final REC letter. Please contact the REC coordinator before you submit the
documents to our office if there are any discrepancies or mistakes in the REC letter.

Information sheets and consent forms should be on SLaM headed paper with local contact information

Evidence of proper HR arrangements with the Trust. This will be assessed during the R&D review
process. Please see guidance on R&D cover guidance notes for details. Please be aware that students and
academic employees without an NHS position need to apply for a research passport to access an NHS
organization for research purposes.
For further information please visit the link below:
http://www.nihr.ac.uk/systems/Pages/systems_research_passports.aspx
Additional Documents needed for Clinical Trials of Investigational Medicinal Products
As there are additional legal requirements for this type of study the R&D Office will also require the following
documents to be submitted in addition to those listed above.

Evidence of training in Good Clinical Practice for all members of the research team conducting trial
related procedures.

Where your trial is sponsored by KCL, SLaM, GSTT, KCH you will also need to provide evidence of
Pharmacovigilance and Trial Master File and Essential Documents training which is available through the
KHP CTO at: http://www.khpcto.co.uk/NonCommercial/trainingEvents.html . This training needs to have been
undertaken, or updated within the last 18 months.

Confirmation of Clinical Trial Authorisation from the MHRA
Method B: If you are adding SLaM as a site, please send all the documents listed in Stage 1 and 2
together.
R&D Contacts
Jenny Liebscher R&D Governance Manager jennifer.liebscher@kcl.ac.uk 020 7848 0251
Adriana Fanigliulo R&D Research Governance Facilitator adriana.fanigliulo@kcl.ac.uk 020 7848 0862
Alice Murray R&D Research Governance Facilitator alice.1.murray@kcl.ac.uk 020 7848 0790
SLaM / IoPPN R&D Office, Room W1.11 Institute of Psychiatry, Psychology & Neuroscience, De Crespigny
Park London SE5 8AF
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