Joint Research Office
Office Location:
1st Floor Maple House
149 Tottenham Court Road
London W1T 7DN
Postal Address:
UCL,
Gower Street
London WC1E 6BT
Tel No. 0203 447 9995 Fax No 0203 447 9937
Web-sites: www.ucl.ac.uk/jro; www.uclh.nhs.uk
JRO RMG RSS SOP-02
Standard Operating Procedure (SOP) for
Categorisation and Sponsorship of “Simple”
Studies
SOP ID Number
Version Number
JRO RMG RSS SOP-02
Version 1.0
Author:
Name and Job Title
Approved by
Date:
Dr Susan Kerrison
Head of Risk and Regulation
Target Trusts
UCLH and Royal Free
Target Audience
SRA, DIO and RNCs
Effective Date
March 2012
Related SOPs
SOP e-Document kept: G: \RM&G Team\NIHR RMG RSS SOPs\ Final;
S:RMG\NIHR RSS SOPs
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SOP for Categorisation and Sponsorship for “Simple” studies
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Review Date
March 2014
Revision Chronology
Previous SOP ID Number
Effective
Date
Reasons for Change
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Author
Joint Research Office
Standard Operating Procedure (SOP) for
Categorisation and Sponsorship of “Simple” Studies
1. SUMMARY
This SOP is part of the suite of SOPs to implement the NIHR Research Support Services
Framework. It describes the processes for granting UCL, UCLH and RFH sponsorship to
“simple” studies.
2. DEFINITIONS
Box 1
“Simple” or “Complex”
Any study where the following boxes are selected for screening question 2 on the NHS R
and D and NHS REC form should be deemed a “simple” study. Any other studies should be
treated as "complex".
•
•
•
•
Study administering questionnaires/ interviews for quantitative analysis, or using
mixed quantitative/qualitative methodology
Study involving qualitative methods only
Study limited to working with human tissues samples (or other biological samples)
and data
Study limited to working with data
“External sponsored studies” - studies not sponsored by UCL, UCLH or RFH for which
UCLH or RFH host approval is required.
3. PURPOSE and SCOPE
The purpose of this SOP is to
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describe the process for classifying studies as “simple” or “ complex”
outline steps required to process a “simple” study including deciding on
sponsorship, establishing whether contract is required
identify the responsibilities for processing “simple” studies
The SOP does not cover the specific requirements for NHS permission which is dealt with in
NIHR RSS RMG SOP 05
This SOP does not apply to UCL sponsored CTIMPs. A list of published UCL sponsored
CTIMP SOPs are available at:
http://www.ucl.ac.uk/jro/standingoperatingprocedures/document-library
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4. RELATED SOPs
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JRO RMG RSS SOP 03
JRO RMG RSS SOP 05
JRO RMG RSS SOP 07
JRO RMG RSS SOP 06
Sponsorship and Approval of “Complex” studies
NHS Permissions
Honorary contracts and letters of access
External Agreements: Set up and Control
5. JOINT RESEARCH OFFICE (JRO) POLICY
All SOPs produced from the JRO must be used in conjunction with local NHS Trust and UCL
policies and procedures. Where applicable there is also a requirement to include
stakeholder engagement as appropriately identified.
The JRO represents both UCL, UCLH or RF as the Sponsor and UCLH and RF as
Participating Sites, depending on the type of research study. The JRO is responsible to
ensure that appropriate research management and governance processes are in place. The
RMG RSS SOPs will provide a quality assurance system for these requirements.
6. BACKGROUND
This SOP complies with


Research Governance Framework for Health and Social Care 2005 (2nd Edition),
NIHR Research Support Services framework
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7. RESPONSIBLE PERSONNEL AND THEIR DUTIES
Responsible person
1 Database and Information
Officer (DIO)
Summary of duies
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2 Senior Research Administrator
(SRA)
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3 RM & G Network Manager/
QA manager
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4 Research Network Coordinator (students)
5 Research Network Coordinators (RNC)
Assesses whether project is a research study.
Assesses whether project is “simple” or
“complex”.
Sets REDA flag accordingly
Refers “complex” studies to RNC.
Assesses whether a sponsor is required
Refers hosted studies to SRA
Assesses eligibility for UCL sponsorship
Refers study to contract/finance team is
required
If eligible processes study for UCL sponsorship
If UCLH or RFH NHS permission is required,
refers to SRAs
Assesses whether project is research
Assesses whether project is “simple” or
“complex”.
Sets REDA accordingly
Refers “complex” studies to RNC.
Assesses whether a sponsor is required
Refers study to contract/finance team if required
Processes sponsorship for UCLH and RFH if
required
Processes NHS permissions for UCLH and RFH
in accordance with RMG RSS SOP 05
Assesses whether projects referred by DIO,
RNC or SRA are research
Quality control host approval and sponsorship
processes as outlined in relevant SOP
Advise and confirm sponsorship decision on a
cases by case basis when required

Reviews and processes student studies
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
Assesses whether project is a research study
Assesses whether project is “simple” or
“complex
Processes “complex” studies in accordance with
RMG RSS SOP 03
Assesses whether projects referred by DIO,
RNC or SRA are research
Advises and confirms a decision whether
contractual arrangements are required
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6 Head of Risk and Regulation
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7 Contracts Manager

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8. PROCEDURE
8.1 The following people may receive studies from research teams
 Database Information Officer (DIO)
 Senior Research Administrators (SRA)
 Research Network Co-ordinators (RNC)
On receipt of a study, the DIO, SRA, or RNC should assess whether the study is research.
Information about this can found at http://www.nres.npsa.nhs.uk/applications/is-your-projectresearch.
If the DIO, SRA or RNC is uncertain whether to classify the project as a research study then
they should refer the study or the Senior RNC or Head of Risk and Regulation for an
opinion.
8.2 If the study is deemed a research study then the DIO, SRA and RNC should assess
whether the study is to be categorised as “simple” or “complex” as in Box 1 above. After
categorisation the flag should be set in REDA.
8.3 All “complex” studies will be referred to the RNC for processing. DIO and SRAs will
handle both the sponsorship and host approval processes for “simple” studies.
8.4 For simple studies, the DIO or SRA will decide whether the study requires sponsorship
or has a sponsor outside UCL, UCLH or RF. If UCLH, RFH or UCL sponsorship is required
the DIO or SRA will assess which model is applicable - see box 2. After contracts review see
8.5 below, studies with a sponsorship which is not UCLH, RFH, or UCL which require UCLH
or RFH NHS permission will be then be approved in accordance with JRO RSS RMG SOP
05
Box 2 Rules for UCLH, RFH or UCL Sponsorship of “Simple” studies
1. UCLH and Royal Free will sponsor non CTIMPs where
•
The study is registered and managed within the JRO
•
The study is single site and recruiting only NHS patients at the site sponsoring the
study.
2. UCL will sponsor other “simple” studies if Chief Investigator (CI) has a substantive
employment contract or an honorary contract/passport with UCL.
3. UCL will sponsor student studies, if students are undertaking a recognised course with
UCL
4. The JRO has flexibility in how it allocates sponsorship particularly for single site and
student studies. In some circumstances, it might be advisable to take a pragmatic approach
to allocation of sponsorship. The Research Network Manager will advise.
8.5 Studies will handled by the following staff
UCLH or RFH hosted “simple” studies
SRAs
UCLH or RFH sponsored “simple” studies
SRAs
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UCL students studies
Other UCL sponsor “simple” studies
RNC (students)
DIO
Contracts
8.6 The RNC (students) will assess the need for agreement for student studies. Only in
exceptional circumstances will formal agreements be required for student studies. In other
circumstances, the requirements for studies will be written into a specifically tailored
approvals letter.
8.7 At the time of finalising this SOP, a review of requirements for contracts is in progress
which may change the following requirements. When this SOP was approved, studies in
following categories needed to be referred to the contracts/finance team for a review

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studies where monies are transferred between institutions eg UCL and UCLH or UCL
and North Midx
involves a commercial organisation
involves the transfer of identifiable data or human tissue between institutions
including UCL. Identifiable data is data which contains person information in
particular the names and addresses or dates of birth of patient. That is data which
has not been anonymised or pseudonymised. Pseudonymised data is data which
has identifiable information removed and replace with a unique key.
Processing UCL, UCLH and RFH sponsored and hosted “simple” studies
8.8 For UCL sponsored “simple” studies, no UCL risk assessment form, or UCL insurance
form is required to be completed. Investigators will be asked to complete a Data Protection
Form but this is currently under review. The investigator will be advised on the appropriate
wording for complaints and insurance for Subject Information Sheet and Protocol as in
Appendix 1.
8.9 For studies hosted UCLH or RFH which meet the criteria for either UCLH or RFH
sponsorship as in Box 2, no other sponsorship approval processes are required.
8.10 Studies which require NHS permissions will then be processed under JRO RMG RSS
SOP 05.
8.11 The study documentation should then be entered onto REDA.
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Flow diagram for a “simple” study
Study sent to SRA, DIO or RNC
SRA. DIO or RNC to register and assign R and D number
SRA, DIO or RNC decides “simple” or “complex” according to definition
below based on question A5 of ethics form - see Box 1. Flag set on
REDA accordingly
Simple
Complex
SRA or DIO to decide if sponsorship required – see
Box 2 for sponsorship rules.
Yes
Trust eg RFH or UCLH
sponsorship processed by SRA
RNC. Then
follow SOP03
No
Yes
UCL sponsorship DIO
Other sponsor ie
hosted study
Does the study need a contract ?
Yes
Refer to contracts and finance team. Contracts to
inform SRA or DIO if contract required and flag
set
No
Is UCLH or RFH NHS permission required ?
Yes
S
No
Agree study after documentation
entered onto database
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9. IMPLEMENTATION & TRAINING
This SOP will be implemented according the procedure agreed by the Approvals
Development Group.
10. PUBLICATION & COMMUNICATION
This SOP is published
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JRO website: http://www.ucl.ac.uk/jro.
G: \RM&G Team\NIHR RMG RSS SOPs\ Final;
S:RMG\NIHR RSS SOPs
The fully approached and signed master copy is also stored in a designated binder
within the JRO.
11. REVIEW
SOPs will be reviewed every 2 years unless an earlier review is required.
12. REFERENCES
JRO Website
http://www.ucl.ac.uk/jro
Research Governance Framework 2005 (2nd Edition)
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digita
lasset/dh_4122427.pdf
NIHR RSS Framework (including Appendix 1 – Glossary of Terms and Acronyms)
http://www.nihr.ac.uk/systems/Pages/RSS_Documents.aspx
13. SIGNATURES
Author:
Name / Job Title
Signature /
Date:
Reviewed by:
Name / Job Title
Signature /
Date:
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Authorised by:
Name / Job Title
Signature /
Date:
16. ACRONYMS
CI
CTIMP
DIO
GCP
ISF
JRO
MHRA
NIHR RSS
PI
QA
REC
REDA
RM&G
RNC
RFH
SI
SOP
SRA
TMF
UCL
UCLH
Chief Investigator
Clinical Trial of Investigational Medicinal Products
Database & Information Officer
Good Clinical Practice
Investigator Site File
Joint UCL/UCLH/Royal Free Research Office
Medicines and Healthcare products Regulatory Agency
National Institute for Health Research (NIHR) Research Support Services
Principal Investigator
Quality Assurance
Research Ethics Committee
Research Database
Research Management & Governance
Research Network Co-ordinator
Royal Free Hospital NHS Trust
Statutory Instrument
Standard Operating Procedure
Senior Research Administrator
Trial Master File
University College London
University College London Hospitals NHS Foundation Trust
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Appendix 1 Wording for patient information sheets and protocols where study is
sponsored by UCL
Wording for patient or subject information sheets
“What if there is a problem “ or “What happens if something goes wrong ? “
If you wish to complain, or have any concerns about any aspect of the way you have been
approached or treated by members of staff you may have experienced due to your
participation in the research, National Health Service or UCL complaints mechanisms are
available to you. Please ask your research doctor if you would like more information on this.
In the unlikely event that you are harmed by taking part in this study, compensation may be
available.
If you suspect that the harm is the result of the Sponsor’s (University College London) or the
hospital's negligence then you may be able to claim compensation. After discussing with
your research doctor, please make the claim in writing to the [add name of Chief
Investigator] who is the Chief Investigator for the research and is based at [add location
name for Chief Investigator]. The Chief Investigator will then pass the claim to the Sponsor’s
Insurers, via the Sponsor’s office. You may have to bear the costs of the legal action initially,
and you should consult a lawyer about this.
Wording for protocols
University College London holds insurance against claims from participants for harm caused
by their participation in this clinical study. Participants may be able to claim compensation if
they can prove that UCL has been negligent. However, if this clinical study is being carried
out in a hospital, the hospital continues to have a duty of care to the participant of the clinical
study. University College London does not accept liability for any breach in the hospital’s
duty of care, or any negligence on the part of hospital employees. This applies whether the
hospital is an NHS Trust or otherwise.”
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