STANDARD OPERATING PROCEDURE
Procedures for arranging sponsorship,
contracts/agreements and indemnity
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UKCRC CTU SOP Template v1.0
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Date
SOP Title: Sponsorship, contracts/agreement and indemnity
SOP No:
SOP Version:
Effective:
1.
PURPOSE
The purpose of this document is to describe the procedures required to 1) ensure that
appropriate arrangements for sponsorship are in place for trials managed by the CTU, 2)
implement appropriate contracts and model agreements with research sites and third
parties, and 3) ensure activities undertaken by the CTU on behalf of the sponsor are
appropriately indemnified in order to comply with the necessary regulations including but
not limited to, the NHS Research Governance Framework for Health and Social Care
(2005)1, the Medicines for Human Use (Clinical Trials) Regulations 2004 No.10312 and the
ICH Guidelines for Good Clinical Practice (GCP)3.
2.
SCOPE
This procedure applies to all research studies and clinical trials carried out by the {CTU
name}, and all {CTU name} staff are responsible for ensuring that the appropriate
sponsorship arrangements are in place, the contracts are implemented and the
insurance/indemnity cover is adequate for the relevant research activities, unless the
sponsor SOPs are to be followed or the sponsor wishes to conduct this process
themselves.
3.
INTRODUCTION
There are a number of processes that need to be put in place prior to the start of a clinical
research study. These include: obtaining sponsorship; ensuring contracts are in place;
and ensuring there is adequate and appropriate insurance/indemnity cover.
The sponsor is defined by the EU Directive 2001/20/EC as ‘an individual, company,
institution or organisation which takes responsibility for the initiation, management and/or
financing of a clinical trial’. The sponsor therefore can be the main funder of the research,
the employer of the Chief Investigator (CI), the educational institution, or the care
organisation where the research is to take place. For CTIMPs, if the main sponsor is not
based in the European Economic Area (EEA; e.g. an American company) it is a statutory
requirement to appoint a legal representative based in the EEA for the purposes of the
trial.
4.
ABBREVIATIONS
4.1
Acronyms and abbreviations
CTA
Clinical Trial Authorisation from MHRA
4.2
IRAS
Integrated Research Application System
MHRA
Medicines and Healthcare products Regulatory Agency
mNCA
Model agreements for non-commercial research in the Health Service
Definitions
Contract: A written, dated, and signed agreement between two or more involved parties
that sets out any arrangements on delegation and distribution of tasks and obligations and,
if appropriate, on financial matters. The protocol may serve as the basis of a contract.
Funder: The Institution, Body or Individual(s) providing funding for the study (unless the
Sponsor already covers this role) either through grants, contracts or donations.
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SOP Title: Sponsorship, contracts/agreement and indemnity
SOP No:
SOP Version:
Effective:
Indemnity: Indemnity provides protection against any action by an individual, a group or
an organisation that believe they received bad or negligent services, and incurred a loss as
a result. Most professional bodies have professional indemnity cover; in some cases it is
compulsory. The limit of an indemnity policy relates to the maximum amount of money that
an individual or organisation will pay out in the event of a claim being made.
Sponsor: An individual, company, institution or organisation which takes responsibility for
the initiation, management and/or financing of a clinical trial.
5.
RESPONSIBILITIES
CI: Must ensure sponsorship of the trial has been obtained before ethical approval is
sought. They must also ensure that the appropriate contracts and model agreements with
research sites are implemented, and that the activities undertaken by the CTU are
appropriately indemnified.
Sponsor: Takes ultimate responsibility for the management and/or financing of the study.
The sponsor may delegate these activities as appropriate to the CI, the CTU and/or other
organisations. Delegation of responsibilities must be formally documented in the study trial
master file (TMF).
6.
PROCEDURE
6.1
ARRANGING SPONSORSHIP
Please refer to your sponsor’s SOP(s) on Applying for Sponsorship for specific details on local
procedures that should be adhered to.
6.1.1 The CI can initiate the process of arranging sponsorship either at the time of preparation
and submission of the Research Grant Application if required to do so by the funding body
or sponsor, or on receipt of the Grant Award Letter and subsequent approval of funding.
To ensure that there are no implications with respect to the sponsor’s insurance policy, the
earlier this is initiated the better.
6.1.2 The CI should contact an appropriate representative (for NHS, usually within the Research
& Development (R&D) office) of the institution/organisation to act as sponsor for the study.
Where appropriate, the institution/organisation should be the substantive employer of the
CI. N.B: The institution may wish to approach another organisation to act as co-sponsor
for the study and assume some of the sponsorship responsibilities. The delegation of
responsibilities between the two sponsors should be agreed, documented and authorised
by appropriate representatives of both sponsor institutions/organisations.
6.1.3
The sponsor’s representative should advise the CI regarding the documentation required
to further the sponsorship application (e.g. protocol, ethics application) and current
versions should be provided to them promptly.
6.1.4
The sponsor may wish to perform a risk assessment in order to establish whether their
responsibilities will be executed properly by the trial study team before they formally agree
to be the sponsor. This may be done by the CTU if delegated and as defined in the
contract agreement.
6.1.5
The sponsor will usually inform the CI by letter once sponsorship has been agreed.
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SOP Title: Sponsorship, contracts/agreement and indemnity
SOP No:
SOP Version:
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6.1.6
The CI will usually be asked to sign a letter of sponsorship/sponsor registration form (see
supporting documents), and a copy of this letter should be kept in the TMF.
6.1.7
The CI should ensure that the research team can comply with the sponsor’s requirements
which may be drawn up in a CI letter of responsibility/contract (see supporting documents)
or sponsor SOPs. This will include undertaking to communicate promptly and effectively
with the sponsor to satisfy and reassure the sponsor that the sponsor’s obligations on the
authorisations, the financing and the progress reporting (including emerging safety data) of
the study are being met.
NOTE: It is the trial manager’s responsibility to identify, at the earliest possible stage, the
appropriate sponsor representative who is able to sign off documentation (e.g. protocol
amendments, IRAS applications) on behalf of the sponsor.
6.2
CONTRACTS/AGREEMENT
Please note that all relevant contracts are in place before trial activity commences.
6.2.1. Contracts between the Funder and the CI / Host Institution

Following receipt of a favourable response from the sponsor, the funder may issue a
contract to the Sponsor/Employing organisation of the CI.

Once the CI or designated team member has reviewed and agreed the contract, it should
be signed off by the relevant parties as per local processes (e.g. the sponsor, the
appropriate contract department of the Host Institution and/or by the Director of the CTU)..
This will highlight the responsibilities required of the sponsor and set the terms and
conditions of the funding agreement along with a timeline for study payments.

The trial manager is responsible for ensuring that a copy of this contract is retained in the
TMF within the CTU and that the terms and conditions are followed.
6.2.2. Sub-contracts

Where the CTU is being sub-contracted as a service provider (e.g. randomisation
provision, database provision, trial management), the CTU, together with the Host
Institution’s office(s) for business development, will produce a contract agreement that will
include full details on the provision of services.

This contract will then be sent to the study’s CI (or delegate) for review and signed off by
the relevant parties as per local processes (e.g. employer or host institution).

The lead CTU member is responsible for ensuring that a copy of this contract is retained in
the TMF within the CTU and that the terms and conditions are followed.
6.2.3 Site agreements

Site agreements will be issued between the sponsor and the appropriate NHS trust(s) for
each of the research sites. For non-commercial research in the Health Service a model
agreement (mNCA), that has been developed to ensure compliance with the applicable UK
law and institutional arrangements is the preferred model and is available to use (see
supporting documents).
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SOP Title: Sponsorship, contracts/agreement and indemnity
SOP No:
SOP Version:
Effective:

The CI or designated CTU team member should instruct and monitor contract activity.

At each site, the Principal Investigaor (PI) is responsible for ensuring that the research
team complies with the site-specific delegated responsibilities outlined in the model
agreement.

Delegation of roles and responsibilities may be documented in for example, a Study
Delegation Log (see supporting documents) which clearly defines the undertakings of the
various parties with a contracted role in the clinical research study. The Study Delegation
Log should then be signed by all parties.

The study should not commence at the sites concerned until all such required contracts
are in place.

A copy of the signed site agreement must be kept in the TMF and study site file.
6.2.4 Other third party contracts/agreements



The sponsor will liaise with third parties (e.g. manufacturers, non-NHS laboratories,
commercial research etc) to have a contract/agreement issued.
The sponsor is responsible for monitoring contract activity and ensuring that the third
parties comply with the study protocol, although this may be delegated to the CTU.
The lead CTU member is responsible for ensuring that a copy of this contract/agreement is
retained in the TMF within the CTU and that the terms and conditions are followed..
6.2.5 Financial Disclosure

The CI or designated team member should ensure that the financial arrangements are
transparent and that they follow the terms and conditions of the contract.
6.3
INDEMNITY

The sponsor must provide indemnity for all investigators taking part in the clinical trial.

If the sponsor is an NHS Trust they will generally only be able to provide cover in the event
that clinical negligence is proven.
If the sponsor is a University, they may also be able to provide insurance for non-negligent
harm. (Refer to the Sponsor’s SOPs for full details)
The CI or designated CTU study team member should check that the sponsor’s indemnity
arrangements are in place prior to the start of recruitment and are clearly detailed in the
protocol and the patient information sheet.
The CI or trial manager must inform the sponsor of any substantial amendments made to
the study protocol in order to ensure that the insurance and indemnity cover is applicable
throughout the entire course of the study. Failure to do so could compromise the validity of
any insurance and indemnity cover.



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SOP Title: Sponsorship, contracts/agreement and indemnity
SOP No:
SOP Version:
Effective:

7.
SUPPORTING DOCUMENTS
Number
Title
SD001
Letter of sponsorship template
SD002
CI letter of responsibility template
SD003
Model Agreement for non-commercial research in the Health Services
(mNCA) template
SD004
Study Delegation Log example
Institution SOP: Applying for Sponsorship
8.
REFERENCES
(1)
Research Governance Framework for Health and Social care. 2nd Edition, (2005)
http://www.dh.gov.uk/en/Aboutus/Researchanddevelopment/AtoZ/Researchgovernance/DH_4002
112
(2)
Statutory Instrument 2004 No. 1031 The Medicines for Human Use (Clinical Trials)
Regulations 2004
http://www.opsi.gov.uk/si/si2004/20041031.htm
(3)
ICH Guidelines for Good Clinical Practice (GCP).
http://www.emea.europa.eu/pdfs/human/ich/013595en.pdf
(4)
Model agreements for non-commercial research in
http://www.ukcrc.org/regulationgovernance/modelagreements/mnca/
9.
the
APPENDICES
Process flowcharts
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Health
Service
SOP Title: Sponsorship, contracts/agreement and indemnity
SOP No:
SOP Version:
Effective:
SD003: MODEL AGREEMENT FOR NON-COMMERCIAL RESEARCH IN THE
HEALTH SERVICES (MNCA) TEMPLATE
http://www.ukcrc.org/index.aspx?o=1692
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SOP Title: Sponsorship, contracts/agreement and indemnity
SOP No:
SOP Version:
Effective:
SD004: STUDY DELEGATION LOG TEMPLATE
Delegation log
STUDY LOGO
SITE NAME - Site staff and responsibilities
Ethics reference: _________, ISRCTN_________, EudraCT_______________
CI
1.
Overall responsibility for <<>> study at site
2.
Submission of ethics, MHRA and R&D applications
3.
Appoint, support and supervise research nurse
4.
Maintain regular contact with and notify <<>> study
office of progress, problems and any unexpected
event or development
5.
Represent centre at collaborators meetings
6.
Maintain site file in accordance with GCP
7.
Patient care and management
8.
Perform treatment as per <<>> protocol and complete
treatment CRF
9.
Identify eligible patients and inform them about <<>>
study
PI
Research
nurse
10. Keep clinic log of all patients referred for <<>>study,
11. Contact eligible patients regarding participation
12. Confirm eligibility, and obtain written informed
consent; forward copy of consent form to study office
13. Arrange and undertake recruitment follow-up clinics
for study participants, including <<>>
14. Ensure patients listed for appropriate treatment and
study paperwork available for <<>> to complete
15. Collect baseline, treatment and follow-up data for all
participants using current version of appropriate trial
paperwork
16. Enter data collected locally into <<web-based
database>>
17. Maintain participant files containing trial paperwork
18. <<Maintain records relating to study drug, including
drug accountability, temperature monitoring, etc.>>
19. Report adverse events in a timely fashion
<<(preferably via the web-based database)>>, and
seek additional clinical details if required
20. Overview of adverse events; assessment of
seriousness and onward reporting as appropriate
21. Report any breaches of trial protocol or GCP
22. Overview of breaches reported; assessment of
seriousness and onward reporting as appropriate
23. Maintain contact with participants (assisting in
tracking down those with whom the study loses
contact) and provide support to participants where
necessary
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SOP Title: Sponsorship, contracts/agreement and indemnity
SOP No:
SOP Version:
Effective:
24. Comply with Research Governance, Ethics, MHRA
and other regulatory requirements
25. Closure of study; archiving of study documents
26. To undertake other appropriate tasks in relation to the
conduct of the <<>> trial as delegated by the CI/PI
Delegation log
STUDY LOGO
SITE NAME - Site staff and responsibilities
Ethics reference: _________, ISRCTN_________, EudraCT_______________
I confirm that the trial related duties described on page 1 of this document have been delegated to
me:
Name
Study Involvement
Initials
Signature
From
To
__/__/__
__/__/__
……………
……………………....
__/__/__
__/__/__
……………
……………………....
CI, Chief Investigator
…………………………….
PI, Principal Investigator
…………………………...
Research Nurse/Recruitment co-ordinator
…………………………...
__/__/__
__/__/__
……………
……………………....
…………………………...
__/__/__
__/__/__
……………
……………………....
…………………………...
__/__/__
__/__/__
……………
……………………....
<<Other study members>>
…………………………...
__/__/__
__/__/__
……………
……………………....
…………………………...
__/__/__
__/__/__
……………
……………………....
…………………………...
__/__/__
__/__/__
……………
……………………....
…………………………...
__/__/__
__/__/__
……………
……………………....
…………………………...
__/__/__
__/__/__
……………
……………………....
…………………………...
__/__/__
__/__/__
……………
……………………....
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