R&D Office
South London & Maudsley NHS Trust / Institute of Psychiatry (KCL)
Information for Commercial Companies in relation to research contracts
There are several issues that need to be considered when wishing to initiate a
project within the South London and Maudsley NHS Trust or Institute of Psychiatry,
KCL. These include:

Funding of the study
o Direct and Indirect Costs
o NHS Cost Identification

Review of Clinical Trial Agreement (including Indemnity Arrangements)

Peer Review of Study

Risk Assessment of Study (for Clinical Trials)

R&D Approval

Involvement of the Clinical Trials Unit

KCL Insurance
Each of these will be covered separately in this document.
Funding of the study
Direct and Indirect Costs

It is a requirement that all grants and contracts to be held by Institute of Psychiatry
or South London and Maudsley NHS Trust staff are administered through the
Institute of Psychiatry, King’s College London Research Grants & Contracts Office.

NHS costs (the support costs that are required to enable clinical services to
accommodate a research study), if they are to be incurred, must be included in any
contract negotiation process. These will be calculated by the R&D Office on the
basis of the identified costs given below. R&D approval will be given only where
NHS costs have been fully included.
NHS Cost identification

The South London and Maudsley NHS Trust requires reimbursement (usually via
the Institute of Psychiatry, KCL Research Grants and Contracts Office) for all NHS
costs that might be incurred as a result of accommodating commercial research
activity. Arrangements for payment to pharmacy can be included in this although
often a separate agreement is made directly with pharmacy. Pharmacy costs have
therefore been included below but may not be included in this agreement.
NHS costs will be calculated by the R&D Office on the following basis:
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R&D Office
South London & Maudsley NHS Trust / Institute of Psychiatry (KCL)
Information for Commercial Companies in relation to research contracts
Access charge to patients
Access charging is based on the recognition that there is commercial value in
information relating to patients, and also that the first outpatient visit can be
expected to take longer than usual if a patient is taking part in research.
Access charge:
£150 per patient
Staff time
Where NHS staff are involved in commercial research, hourly rates will be charged
as follows:
Consultant Psychiatrists and Clinical Psychologists
Other medical grades
Other clinical psychologist grades
Nurses
Occupational therapist
£129 / hour
£ 52 / hour
£ 44 / hour
£ 25 / hour
£ 36 / hour
Administration charges
R&D office administration charges will be applied as follows:
Contract costing and R&D approval processing:
Indemnity & Clinical Trial Agreement Review
£1,000
£200
Pharmacy charges [as agreed with Maudsley Pharmacy]
Below is a guide of the pharmacy costs which have been provided by the Maudsley
Pharmacy. We do request that contact is made with pharmacy to discuss the
requirements of your trial and come to a final costing directly with them.
1) Administration and Set Up charge (including electronic software support,
monitoring visits, close down and organising of trial for:
Oral or injectable
issued by dispensary staff only
Oral and injectable
issue involves dispensary and technical services staff)
Issue by technical Services Staff only
Extra Storage Space (per shelf)
Fridge Storage
Receipt of goods (each delivery)
Controlled Drugs
£ 910
£1920
£1205
£ 85
£130
£15
25% surcharge
2) Dispensing, including returns/compliance check
Per patient visit (dispensing staff only)
Per item dispensed (technical services staff)
Controlled Drugs
£ 34
£ 52
25% surcharge
3) Re-labelling
Per episode
£19
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R&D Office
South London & Maudsley NHS Trust / Institute of Psychiatry (KCL)
Information for Commercial Companies in relation to research contracts
4) Other Charges
Extending working hours (per half hour)
£65
Emergency out of hours, callout to emergency,
on call pharmacist eg for code break (per hour)
£125
Participation in GMP/GCP auditing of trial (per hour) at current hourly rate for
pharmacist/pharmacy technician
5) Disposal of trial-related waste medicines (per bin burn)
£60)
6) Reviewing archived records
£ 38 (minimum charge
£ 32
7) Faxing documentation (per fax)
£1
Radiology charges
The will be considered on a case by case basis
Inpatient stays
Inpatient stays over and above normal clinical requirement: £350 / day
Other costs
On occasion there may be other NHS costs outside the above categories. These
will be considered on a case by case basis.
Review and Approval of Clinical Trial Agreement
There are two template Clinical Trial Agreements currently being used within the
organisation. Both of these agreements contain the ABPI standard indemnity for
Medicinal Clinical Trials. Details of the two types of agreement are set out below:
Both South London and Maudsley NHS Trust and Institute of Psychiatry, KCL
involvement
Where the study involves the South London and Maudsley NHS Trust and Institute
of Psychiatry, KCL companies are strongly advised to use our template tripartite
agreement which is available from the R&D Office upon request. If this contract is
used without amendment then it will not need to be reviewed by the Institute of
Psychiatry, KCL and South London and Maudsley NHS Trust, thereby speeding up
the process of study set-up.
South London and Maudsley NHS Trust only
Where the study only relates to the South London and Maudsley NHS Trust (very
rarely the case), companies are strongly advised to use the model agreement
produced by the Department of Health and ABPI. This is available from the
Department of Health Website or from the R&D Office. If this agreement is used
without amendment then it will not need to be reviewed by the legal department
within South London and Maudsley NHS Trust, thereby speeding up the process of
study set-up.
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R&D Office
South London & Maudsley NHS Trust / Institute of Psychiatry (KCL)
Information for Commercial Companies in relation to research contracts
Peer Review
It is a requirement that all commercially sponsored research undertaken with South
London and Maudsley NHS Trust is peer reviewed through the R&D Office. You
will be asked to provide a protocol or summary to the R&D Office (preferably
electronically), which will then arrange for this to be peer reviewed.
Risk Assessment (Clinical Trials)
It is out policy that all Clinical Trials (both medicinal and non-medicinal) are required
to go through a risk assessment process. You will be asked to provide a protocol or
summary to the R&D Office (preferably electronically) who will then arrange for this
to be risk assessed by a subgroup of our Clinical Trials Co-ordinating Committee.
R&D Approval
It is a requirement that any investigator wishing to undertake research that is to
involve the use of South London and Maudsley NHS Trust patients, their records or
materials, or that will use South London and Maudsley NHS Trust resources in any
way, must seek R&D approval from the joint South London and Maudsley NHS
Trust/Institute of Psychiatry, KCL, R&D Office. This can be facilitated by the
Sponsor Company or undertaken by the investigator concerned.
Involvement of the Clinical Trials Unit
It is a requirement that all Medicinal Clinical Trials are considered by our Clinical
Trials Unit which should be contacted at an early stage.
King’s College London (KCL) Insurance Arrangements
Outside the usual indemnity arrangements with the Trust and any insurance that the
company has for itself, KCL will be able to provide cover for its staff under its no
fault compensation insurance. This insurance covers KCL’s legal liability for (i)
bodily injury to people participating in a sponsored clinical trial or human volunteer
study, and (ii) payment of damages or compensation in respect of any claim made
for bodily injury to persons participating in a sponsored clinical trial or human
volunteer study. The basis for damages or compensation will be in accordance with
ABPI guidelines being payable irrespective of fault on KCL’s part (so-called ‘No
Fault Compensation’).
The 2006/07 limits are:£5,000,000 limit per clinical trial/study (including costs) irrespective of the number of
research subjects.
£10,000,000 limit in any period of insurance
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R&D Office
South London & Maudsley NHS Trust / Institute of Psychiatry (KCL)
Information for Commercial Companies in relation to research contracts
For further information regarding this please contact Paul Labbett at King’s College
London Enterprises.
Details of all these processes are available on our website
www.iop.kcl.ac.uk/RandD
Contact Details
R&D Office
Mrs Gill Lambert
Research Governance/Clinical Trials Facilitator
R&D Office (PO05)
Room W1.08
Institute of Psychiatry, KCL
De Crespigny Park
Denmark Hill
London
SE5 8AF
e-mail g.lambert@iop.kcl.ac.uk
Telephone 020 7848 0215
Fax 020 7848 0147
Research Grants Office
Lorraine Davison
Senior Management Accountant & Contracts
Research Grants Office (PO04)
Institute of Psychiatry, KCL
De Crespigny Park
London SE5 8AF
email: l.davison@iop.kcl.ac.uk
Tel: 020 7848 0121
Fax: 020 7848 0671
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R&D Office
South London & Maudsley NHS Trust / Institute of Psychiatry (KCL)
Information for Commercial Companies in relation to research contracts
Clinical Trials Unit
Caroline Murphy
Clinical Trials Unit Manager
Mental Health & Neurology CTU
Institute of Psychiatry, KCL
103 Denmark Hill
De Crespigny Park
London SE5 8AF
e-mail c.murphy@iop.kcl.ac.uk
Tel: 020 7848 5273
Fax: 020 7848 5229
King’s College London Enterprises
Mr Paul Labbett
Director of Research Grants & Contracts
9th Floor, Captial House
Guy’s Hospital
St. Thomas’s Street
London
SE1 9RT
e-mail paul.labbett@kcl.ac.uk
Tel 020 7848 8184
Pharmacy Department
Glynis Ivin
Clinical Trials Pharmacist
South London and Maudsley NHS Trust
Maudsley Hospital
Denmark Hill
London
SE5 8AZ
e-mail glynis.ivin@slam.nhs.uk
Tel 020 7919 5043
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