standard operating procedure for the preparing and maintaining a ...

ACCORD
NHS Lothian R&D and
The University of Edinburgh
SOP Number: GS001v1.1
Effective Date: 15/FEB/2012
STUDY EVALUATION
SOP NUMBER:
GS001
VERSION NUMBER: 1.1
EFFECTIVE DATE:
RELEASE DATE:
15/February/2012
01/February/2012
Signature
Date
02/Feb/2012
Signature kept on file
AUTHOR: Karen Maitland, Research Governance Coordinator, NHS
Lothian R&D
Signature kept on file
02/Feb/2012
APPROVED BY (1): Christine Phillips, Deputy Director, ACCORD
02/Feb/2012
Signature kept on file
APPROVED BY (2): Paul Dearie, QA Manager, ACCORD
REVIEWED BY: Marise Bucukoglu
Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the
latest version
Page 1 of 4

ACCORD
NHS Lothian R&D and
The University of Edinburgh
SOP Number: GS001v1.1
Effective Date: 15/FEB/2012
1. INTRODUCTION
Before any study can begin, involving NHS Lothian patients as participants or NHS
Lothian resources, Management Approval (MA) from NHS Lothian R&D must be
obtained in writing. In order to determine if MA will be granted, a review of the study
must be undertaken. Research review comprises of two sections; governance review
and Scientific and Risk Analysis (SARA) review.
In addition, any study that requires NHS Lothian and/or the University of Edinburgh
(UoE) to assume the role of sponsor(s) must be reviewed by a representative(s) of
the sponsor(s) prior to officially becoming the sponsor(s).
2. PURPOSE
To document the procedures governing the review of clinical research in NHS
Lothian from the perspective of the host organisation (NHS Lothian). Also to
document the procedures for assuming the role of sponsor from the perspective of
NHS Lothian and UoE.
3. SCOPE
This SOP applies to NHS Lothian research governance staff and UoE research
governance staff.
4. REFERENCES
Research Governance Framework for Health and Community Care (Scotland 2006
2 nd ed)
Medicines for Human Use (clinical trials) Regulations 2004 as amended
ACCORD Sponsorship Policy
http://www.accord.ed.ac.uk/standardopprocs/3colpolicies.html
Procedures for Sponsorship, Co-Sponsorship, Agreements and UoE Insurance -
Version 2.1, 14 October 2010 (K:\MVM\Governance Office\Sponsorship\Sponsorship
Guidelines)
Sponsor Process – Pre and Post Funding – Version 1.1, 14 October 2010
(K:\MVM\Governance Office\Sponsorship\Sponsorship Guidelines)
5. PROCEDURE
5.1 Sponsorship
5.1.1 Studies that require NHS Lothian and/or UoE to act as the study sponsor - as
defined by the Research Governance Framework for Health and Community Care
(Scotland 2006 2 nd ed) and the Medicines for Human Use (Clinical Trials)
Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the
latest version
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ACCORD
NHS Lothian R&D and
The University of Edinburgh
SOP Number: GS001v1.1
Effective Date: 15/FEB/2012
Regulations 2004 as amended where applicable – may be forwarded to the Clinical
Research Facilitator at a development stage in accordance with SOP FA001. Such
studies will typically include CTIMPs, other complex interventional studies and
studies investigating a novel device. The Clinical Research Facilitator will inform
representative(s) of the sponsor(s) that the study requires sponsorship.
5.1.2 Other studies may not require facilitation. Such studies that require NHS
Lothian and/or UoE to act as the study sponsor will come to the attention of the
sponsor(s) representative(s) via a request for sponsorship.
5.1.3 The sponsor(s) representative(s) will use documents: “Procedures for
Sponsorship, Co-Sponsorship, Agreements and UoE Insurance” and “Sponsor
Process – Pre and Post Funding” to ascertain if the study is appropriate for
sponsorship according to the current proposed study methods, procedures and
details. If it is not appropriate, the sponsor(s) representative(s) will liaise with the
Chief Investigator (CI), or designee, to make revisions as necessary.
5.1.4 When the sponsor(s) representative(s) is satisfied that NHS Lothian and/or UoE
can act as the sponsor, it can be recorded in research submissions and any other
relevant documents/agreements. The sponsor(s) representative may feel it is
appropriate to document that NHS Lothian and/or UoE will act as the sponsor “in
principle”, subject to further actions/milestones.
5.1.5 The Clinical Research Facilitator or Study Manager or the sponsor(s)
representative(s), or designee, will subsequently contact the Edinburgh Research
and Innovation (ERI) Contracts Team Manager and/or the R&D Principal Research
Manager to discuss the study and agree how to proceed with respect to contractual
arrangements. This will proceed and conclude in accordance with work instruction
GS001-W01 (Agreement Preparation – Sponsor).
5.1.6 During the course of the study, issues relating to sponsor oversight of the study
will be forwarded to the sponsor(s) representative(s) for resolution. The nature of
sponsor responsibilities are described in the ACCORD policy “Sponsorship Policy”.
5.2 Management Approval
5.2.1 The review of studies that require management approval from NHS Lothian will
undergo a two stage evaluation; governance review and Scientific and Risk Analysis
(SARA) review. The process of governance review and SARA review are described
in work instruction GS001-W02 (Research Review). Governance review will be
completed before SARA review. SARA review will culminate in a presentation of the
study by the SARA reviewer at the SARA meeting. Other matters relating to research
governance can be discussed at the SARA meeting and the proceedings of the
SARA meeting are described in work instruction GS001-W03 (Scientific and Risk
Assessment). If it is decided that management approval is granted to a study, this will
be issued in accordance with GS001-W02.
5.2.2 If management approval is subject to specified conditions (e.g. REC approval,
funding award), evidence that the conditions have been met will be forwarded to the
NHS Lothian R&D office.
Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the
latest version
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ACCORD
NHS Lothian R&D and
The University of Edinburgh
SOP Number: GS001v1.1
Effective Date: 15/FEB/2012
5.2.3 Amendments will be reviewed and considered for management approval
according to work instruction GS001-W05 Amendments.
5.3 Hosted Studies
Studies hosted by NHS Lothian but sponsored by an organisation other than NHS
Lothian and/or UoE may require an agreement to be prepared between the host
organisation and the study sponsor(s). The Principle R&D Manager, or designee, will
ensure that such an agreement is prepared if required, and authorised in accordance
with work instruction GS001-W04 (Agreement Preparation – Host). The agreement
will be executed in parallel with the issue of management approval.
6. RELATED DOCUMENTS
GS001-W01 – Agreement preparation – sponsorship
GS001-W02 – Research review
GS001-W03 – Scientific and risk assessment
GS001-W04 – Agreement preparation – host
GS001-W05 - Amendments
GS001-T01 – Management approval template – optional inserts
GS001-F01 – SARA review and risk assessment form
GS001-F02 – Governance review checklist
GS001-F03 – Amendments checklist
ACCORD Sponsorship Policy
7. DOCUMENT HISTORY
Version Effective Reason(s) for change(s):
Number: Date:
1.0 25/APR/2011 Addition of amendments work instruction
Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the
latest version
Page 4 of 4