SOP 3: Developing and Submitting Grant Proposals, and Contract Sign-off © Keele University

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Research Institute for Primary Care & Health Sciences

Standard Operating Procedure (SOP) Summary Box

Title Developing and Submitting Grant Proposals, and Contract Sign-off

SOP Index Number SOP 3

Version 3.0

Approval Date 09-Nov-2015

Effective Date 23-Nov-2015

Review Date November 2017

Lead Author Rhian Hughes

Reference KCTU/SOP3/v3.0/23-Nov-2015

DISCLAIMER

This SOP is the property of Keele Clinical Trials Unit (Keele CTU), Research Institute (RI) for Primary Care and Health Sciences, Keele University and the content cannot be

reproduced without specific permission from the owner.

All SOPs and associated documents must be accessed through the dedicated SOP area of the RI Intranet to ensure the correct version is being used. If this document is being

accessed through any other method, such as electronic copies saved onto a network drive or in printed form, it is only valid for use if the version number and effective date shown

above is the same as that shown on the RI Intranet.

Any superseded versions of this document need to be promptly withdrawn from use.

Updates to this document will be via a dedicated CTU email. All individuals undertaking functions outlined in this document are responsible for ensuring that they are trained in the

procedures outlined in the correct version of this document. SOP Template v5.0 date 05 Oct 2015

Signature Box

Role Print Name Signature Date

CTU QA Manager

Ruth Beardmore Signed hard copy stored in approved SOP file with QA office

09-Nov-2015

Sponsor QA Manager

Emma Skinner Signed hard copy stored in approved SOP file with QA office

09-Nov-2015

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Version History Log

Version Date Approved

Reason(s) for Change Implementation Plan

2.0 05-03-12 Approval of version 2.0

3.0 23-Nov-2015 Updates to CTU procedures for adoption, review and sign-off of new studies

Sponsor procedures for in-principle approval

Changes in roles

All RI staff will be notified of the revised SOP. Staff are expected to read the updated version of the SOP when it is released, as applicable to their role. The updated procedures are to be implemented from the SOP effective date.

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Table of Contents 1. Purpose ........................................................................................................................ 4

2. Scope and Applicability ................................................................................................. 4

3. Procedures ................................................................................................................... 4

3.1 Studies that can be Supported by Keele CTU ........................................................ 4

3.2 Planning and Developing the Grant Application, Identifying the Academic Team,

Setting the Timelines ........................................................................................................ 5

3.3 Writing the Research Proposal ............................................................................... 6

3.3.1 CTU Support and CTU Feasibility Review ....................................................... 6

3.3.2 Think Tank Support .......................................................................................... 6

3.3.3 User Involvement / PPI .................................................................................... 6

3.3.4 NHS and Clinical Research Network Support .................................................. 7

3.3.5 Intellectual Property ......................................................................................... 7

3.3.6 Costing the Research Proposal ........................................................................ 7

3.4 CTU Adoption, Sponsor Risk Assessment and In-principle Approval, RI / UHNM

Sign-Off: Procedures and Timeline ................................................................................. 8

3.4.1 Scientific Peer Review ..................................................................................... 8

3.4.2 CTU Feasibility Review .................................................................................... 9

3.4.3 CTU Adoption Process ..................................................................................... 9

3.4.4 Sponsor In-principle Approval for CTIMPs ....................................................... 9

3.4.5 Sponsor In-principle Approval for Non-CTIMPs ............................................... 9

3.4.6 Sign-Off of Costings ....................................................................................... 10

3.4.7 RI or UHNM Sign-Off ..................................................................................... 10

3.5 After Grant Submission ......................................................................................... 10

3.6 Confirmation of Award .......................................................................................... 10

3.6.1 Contracting Arrangements ............................................................................. 10

3.7 Operationalising Funded Projects ......................................................................... 10

3.7.1 Study Support Template ................................................................................ 11

3.7.2 Study Sponsorship Arrangements for CTIMPs ............................................... 11

3.8 Grants Submitted in Collaboration with External Institutions ................................ 11

3.9 Sharing of Research Data with Collaborators ....................................................... 11

4. Key Personnel to whom this SOP Applies .................................................................. 12

4.1 PhD Supervisors and Students ............................................................................. 12

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1. Purpose This SOP describes the support processes in place for developing and submitting grant applications for clinical studies of any design that involve primary data collection and that may benefit from Keele CTU support services, and for adopting studies onto the CTU portfolio. 2. Scope and Applicability This SOP applies to all individuals undertaking functions outlined herein. This includes all core Keele CTU staff and all other research, management or admin staff, or students who wish to have their studies adopted for set-up and delivery by the Keele CTU.

This SOP must be followed in line with the NHS Research Governance Framework, and the University, Research Institute and CTU policies. Where applicable to Clinical Trials of Investigational Medicinal Products (CTIMPs) this SOP must be followed in line with the UK Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, and the EU Clinical Trials Directive. Where applicable to non-CTIMP studies this SOP must be followed in line with the appropriate Good Clinical Practice guidance. 3. Procedures

3.1 Studies that can be Supported by Keele CTU Currently, Keele CTU supports Phase III and IV clinical studies (including pilot studies) of any design that:

Are led by Chief Investigators (CIs) / Principal Investigators (PIs) who are Keele University academics affiliated with the Research Institute for Primary Care and Health Sciences (iPCHS); or with the Health Services Research Unit (HSRU) in the Research Institute for Science and Technology in Medicine (iSTM). In these circumstances, Keele CTU will normally be the lead CTU and either Keele University (Keele) or the University Hospitals of the North Midlands NHS Trust (UHNM) will be the Sponsor.

Include Keele academics working as PI co-applicants in studies led by academics from another University. In these circumstances, Keele CTU may be either the lead CTU or a collaborating CTU (for example, taking responsibilities for functions such as coordinating investigation sites, and other specific tasks, as delegated by the Sponsor). The host University of the study’s CI would normally be the Sponsor.

Include UHNM PIs supported by the Keele hub of the Research Design Service (RDS) and the HSRU. In these circumstances, the Keele CTU may be either the lead CTU or a collaborating CTU (for example, taking responsibilities such as coordinating investigation sites, and other specific tasks). Either Keele or UHNM will be Sponsor.

Research proposals to be supported by the CTU will normally:

Fit within the relevant iPCHS or HSRU research group’s strategy and areas of expertise, or

Be supported by the Keele hub of the Research Design Service, or

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Be proposals developed in response to funders’ commissioned calls that align with the expertise of Keele research groups,

Be of a scientific quality that is competitive for national or international funding

Be feasible to be supported by the CTU’s infrastructure, skills and its NHS partnerships.

3.2 Planning and Developing the Grant Application, Identifying the Academic

Team, Setting the Timelines See Milestones for Grant Applications and CTU Adoption See Pathway for Projects to be adopted on the Keele CTU Portfolio The study CI/PI, supported by their relevant research group(s) within iPCHS or HSRU, are responsible for developing and prioritising the academic content of their research proposals, for recruiting the study team / collaborators with the appropriate combination of expertise and experience, allocating tasks and setting deadlines to achieve timely grant submission. Where PIs are based in UHNM, the RDS will provide academic support to develop the grant application and will support identification of academics to be invited to become part of the study team. It is important to consider CTU involvement in study development and grant writing as soon as possible and to involve the HSRU Trial Manager / iPCHS New Studies Manager in helping CIs / PIs in planning the development of the grant application and in providing CTU input. In addition, it is important to identify and recruit experienced researchers to become part of the study team, including a named academic who can represent the CTU. For studies to be adopted by the CTU, the study team should normally include:

Clinical / topical expertise appropriate to the research question

A CTU affiliated statistician*

Experienced CTU affiliated methodologist(s)* (triallist, epidemiologist, social scientist) as relevant to the methods included in the study

Systematic Reviewer / Health Economist if appropriate for the research question

PPI representative(s)

CTU Trial Manager / Study Coordinator *NB RDS statisticians and methodologists are affiliated to the CTU The benefits (or otherwise) of external collaboration must be considered at an early stage, and plans should be in place to include external co-applicants or collaborators, if appropriate. Involving external collaborators may take more time for meetings/feedback; hence this process should be instigated as early as possible. The timelines and delegation of tasks associated with the application should be agreed and clearly articulated, including timelines for submitting the proposal to the CTU Leadership Group for decisions on CTU adoption. The agreed timeline must ensure sufficient time for appropriate engagement of the grant writing team, and of the key staff involved in the sign-off procedures before the submission deadline. i.e.

PPI

Think Tank discussion (Clinical Trials or Epidemiology Think Tank)

CTU input

Peer review, feedback and response loop

Costing exercise

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CTU adoption

Finance and Sponsor Office sign-off

RI (or UHNM) sign-off It is recognised that response-mode applications will often need to be fast-tracked through CTU procedures. However, response-mode applications cannot by-pass CTU requirements for grant applications or the sign-off procedures outlined in this SOP, therefore careful planning and clear communications for response-mode applications are crucial. 3.3 Writing the Research Proposal The CTU recognises that funders’ application forms will vary. CIs / PIs should follow a standard protocol when writing their research protocol, to ensure all aspects of scientific design, logistics, participant safety and data integrity are addressed. The CTU expects that for CTIMPs, CIs / PIs will pay full regard to addressing the headers provided in the HRA Standard Protocol Template as the basis for populating funders’ grant application forms. This should be considered good practice for non-CTIMPs too.

3.3.1 CTU Support and CTU Feasibility Review It is vital that the iPCHS New Studies Manager or the HSRU Trial Manager are informed of the proposal at an early stage and are engaged in providing CTU input as the proposal is developed. They provide: crucial coordination, support and advice in identifying the components that need to be included in the research protocol to ensure feasible research delivery; help to complete core components of grant applications forms, including identification and description of core CTU functions as they need to be applied to the study protocol, CVs, Intellectual Property, research environment, PPI; and help to ensure key functions / costs in the proposal are identified. They can also support CIs / PIs in identifying and recruiting academic members of staff to the study team to represent and provide CTU expertise, if gaps are identified. 3.3.2 Think Tank Support See Aims of Clinical Studies Think Tanks. Think Tank meetings are regularly held to support the development of and peer review process for clinical trials and epidemiological studies. CIs / PIs are encouraged to request a Think Tank to review and provide constructive feedback on the proposed study. The iPCHS New Studies Manager or the HSRU Trial Manager as appropriate can help organise the Study Think Tank. The iPCHS Academic Support Manager holds the calendar for dates/times of Think Tank meetings. 3.3.3 User Involvement / PPI Most funders now require evidence of user involvement / patient and public involvement (PPI) in the development and conduct of research proposals, and it is CTU policy to demonstrate commitment to user involvement in research wherever possible. There are excellent resources available within iPCHS (for primary care studies) and the RDS to ensure evidence of PPI activity in the development, delivery and dissemination of research (iPCHS PPI Framework and Policy and RDS PPI Enabling Involvement) Think early in the development of the proposal about how user involvement could contribute to the study, including checking what evidence is required in the grant application form, and liaise early with the iPCHS (PPI Request Form) or the RDS link – PPI Projects Co-ordinator, to plan and establish the appropriate level of user involvement for the study, including identifying a PPI co-applicant where appropriate.

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3.3.4 NHS and Clinical Research Network Support Where the research proposal requires NHS engagement, iPCHS’ New Studies Manager or HSRU Trial Manager (as appropriate) will support CIs / PIs to liaise with iPCHS’ NHS Engagement and Partnerships Manager and the Spoke Manager of the Primary Care Delivery Arm of the Clinical Research Network (for primary care studies) or the relevant Trust R&D Manager (for secondary care studies) at an early stage, to provide input into feasibility of NHS involvement, design of site-based research activity, potential sites, potential service support and treatment / excess treatment costs and, where required, NHS sign-off and NHS / CRN letters of support. 3.3.5 Intellectual Property The NHS Engagement and Partnerships Manager (for primary care studies) and the relevant Trust R&D Manager (for secondary care studies) can provide advice on identification and management of intellectual property relating to the planned research. 3.3.6 Costing the Research Proposal

The iPCHS’ Business and Finance Manager must be alerted to plans to submit a grant application as early as possible, and must agree the timelines with regard to availability of relevant information to enable completion of accurate and validated costing for the application. Costing of grant applications needs to be an iterative process, where the scale of activity within the research proposal is balanced against grant funding limits, the requirements to secure funding for the core research team and for CTU functions. Where iSTM or UHNM are taking the lead in submitting the grant proposal, iPCHS’ Business and Finance Manager will liaise with the relevant Finance Managers to ensure CTU costs are incorporated into the application. The following need to be taken into account:

Staff support - careful consideration needs to be given regarding the staff members role, which should then be broken down across the component phases of the study. The level of seniority and balance of expertise that is required needs to be decided upon, full or part-time, duration etc. Consideration in particular needs to be given to the following:

o Time allocated to CI / PIs o Statistics / Health Economics / Social Science support o Other methodological input o Research Assistant(s) (RAs) o Study Co-ordinator(s) (SCs) o Research Nurse o IT, database design and maintenance o Quality Assurance (QA) and Sponsor costs (e.g. MHRA fees) o Health informatics support o Administrative support o Collaborators’ time o Supervision and support time from co-applicants

Staff recruitment costs

Associated consumable costs for staff (travel, office costs)

Equipment

Data collection costs o Case report forms o Patient information leaflets o Letters to participants/GPs etc.

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o Printing o Mailing o Data entry o Transcribing costs (if applicable) etc.

User involvement expenses and payments for time and meeting costs

Training costs, both initial and further training events if applicable

Study meetings and associated venue and travelling costs

Steering groups (TSC and DMC) costs

PhD/MPhil studentship fees (if allowed in the funding scheme)

Site costs

Dissemination costs o Conference attendance(s) o Open access publishing o Printing and dissemination of study reports o Communications with users, clinicians and other stakeholders

Indirect costs and overheads (the Business and Finance Manager will advise on what the grant scheme allows and what Keele University expectations are in relation to overheads)

Service Support Costs

Treatment and Excess Treatment Costs

For CTIMPs, the following must also be considered o Pharmacy costs o IMP supply and clinical trial labelling costs

Where grant schemes require ethics approval to be in place before a start date can be confirmed or grant income released, resources to support CTU protocol development, sponsor approval, site identification and set-up, preparation and submission of regulatory applications will need to costed and appropriate funding identified. 3.4 CTU Adoption, Sponsor Risk Assessment and In-principle Approval, RI / UHNM

Sign-Off: Procedures and Timeline The final stages of writing the grant application needs careful management to ensure:

Full protocol development

Internal scientific peer review and incorporation of feedback

Adoption of the study via the CTU Leadership group

Sponsor notification / in-principle approval

Accurate costings

RI or UHNM sign-off 3.4.1 Scientific Peer Review See RDS and CTU Proposal Review Form The RDS, HSRU, iPCHS and CTU operate an integrated internal peer review process for new grant applications. Peer review and response to reviewers’ feedback must be completed satisfactorily, in order to gain CTU adoption and RI or UHNM sign-off of the grant application prior to submission. The HSRU Trials Manager and iPCHS New Studies manager (as appropriate) will liaise with senior research group leads to identify (normally three) peer reviewers for the study protocol. iPCHS’ Academic Support Manager will manage the peer review process and feedback to CIs/PIs. The HSRU Trials Manager and iPCHS New Studies Manager (as appropriate) will liaise with CIs/PIs to ensure feedback from the peer reviews is addressed appropriately.

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3.4.2 CTU Feasibility Review The iPCHS New Studies Manager or the HSRU Trial Manager will contribute their CTU Feasibility Review at the same time as the Scientific Peer Review is completed. 3.4.3 CTU Adoption Process See Pathway for Projects to be adopted on the Keele CTU Portfolio The CTU Adoption Process is an iterative one. CIs / PIs need to approach the CTU early in the development of their research protocol. They should ensure the HSRU Trial Manager or iPCHS New Studies Manager (as appropriate) are involved in supporting the development of the study at an early stage. Where feasible, CIs / PIs should convene a clinical study Think Tank (section 3.3.2 above), to enable CTU co-applicants to be identified and recruited to support their study, and for key issues relating to scientific design and CTU methodology to be addressed in the research design. CTU Adoption is formalised via the CTU Leadership Group, and is finalised once the CTU Leadership Group are satisfied that there is the appropriate level of CTU engagement in the development and management of the study, peer reviews of the study are appropriate and feedback has been appropriately addressed, CTU costs are incorporated either into the grant submission or separate resources are identified and committed to the CTU, the CTU has the capacity to deliver the study, appropriate sponsor arrangements can be put in place. The iPCHS New Studies manager or the HSRU Trial Manager will manage the process to submit studies to the CTU Leadership group for formal adoption. Requests for CTU adoption can be managed either via a meeting of the CTU Leadership Group or through email. 3.4.4 Sponsor In-principle Approval for CTIMPs See SOSOP1 Applying for Sponsorship See POO1 Sponsor Oversight Framework See POO2 Sponsor Management Framework Where Keele is required to be sponsor of the study: As soon as the protocol / grant application is at a sufficiently detailed stage of development the CI/PI will submit it to the Sponsor QA Manager for review and risk assessment. The Sponsor QA Manager will normally provide a response on whether or not Keele will, in principle, be able to sponsor the study within five working days. Where UHNM is required to be sponsor of the study: As soon as the protocol / grant application is at a sufficiently detailed stage of development the CI/PI will submit it to the UHNM R&D Manager for review and risk assessment. The UHNM R&D Manager will normally provide a response on whether or not UHNM will in principle be able to sponsor the study within five working days. 3.4.5 Sponsor In-principle Approval for Non-CTIMPs The CTU Leadership Group will confirm sponsorship arrangements at the same time as they decide on CTU adoption of a study. The RI Director is authorised to confirm Keele as sponsor. The UHNM R&D Director is authorised to confirm UHNM as sponsor.

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3.4.6 Sign-Off of Costings The iPCHS Business and Finance Manager will scrutinise and validate CTU costings and ensure that these are included in the grant application, in line with feedback from the peer and CTU feasibility reviews. 3.4.7 RI or UHNM Sign-Off All grant applications must be signed off by the relevant RI or UHNM Director, the CTU Director, authorised Finance / Contracts lead for the Institution submitting the grant application, and NHS host organisation. Sign-off can only be completed if peer review, CTU feasibility review and adoption, and costings processes have been completed as described in this SOP. 3.5 After Grant Submission

CIs/PIs must ensure that the iPCHS New Studies Manager or the HSRU Trial Manager continue to be included in any correspondence from the funder so that they can keep the study file up-to-date and maintain a record of any changes. This will include: confirmation of arrival of grant submission; requests for additional information; peer reviews and responses to peer reviews; any changes to the protocol or to costings which are required by the funder. If the funder requires significant changes to the study protocol or costings in a way that affects the feasibility of CTU contribution to the study, the CTU Leadership Group must be consulted on changes being proposed, impact on the CTU and mitigating actions. The CTU Leadership Group may review its decision on CTU adoption. Copies of all correspondence to and from the funder, including copies of peer reviews, responses and copies of the letter confirming the outcome of the application must be retained in the relevant study file, ready to be transferred to the Study Master File.

Ensure that all co-applicants have a final copy of the submitted proposal, and copies of all key correspondence from the funder. 3.6 Confirmation of Award On receipt of the grant award, the necessary arrangements for setting-up the following will need to be completed:

Grant contract

Sponsor arrangements

Preparing for study set-up 3.6.1 Contracting Arrangements See Academic Contracts Review Procedure Ensure that the appropriate RI Business and Finance Manager is given a copy of the final grant confirmation letter. At this point, the funder must be informed that all contracting information should be passed to the RI Business and Finance Manager. The RI Business and Finance Manager will liaise with the funder and Directorate of Engagement and Partnerships (DEP) to finalise the funding contract, will set up a research account for the new grant and formalise the budget within that research grant. At this point, the formal contract start date and grant reporting arrangements will be clarified. 3.7 Operationalising Funded Projects Some grant schemes require ethics approval to be in place before a start date can be confirmed or the grant funding released. In this case, specific arrangements will need to be made with the CTU to identify the necessary resources to secure CTU staff support to enable the IRAS application to be prepared. The CI with the support of the iPCHS New

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Studies Manager or the HSRU Trial Manager will initiate Sponsor approval arrangements, development of the protocol to set-up stage and engagement of CTU operational support. For CTIMPs the HRA Standard Protocol Template should be used. 3.7.1 Study Support Template Once funding has been confirmed, the iPCHS New Studies Manager or the HSRU Trial Manager will up-load the study onto the CTU’s Operational Projects log, and liaise with the CTU Senior Trials Manager to identify the CTU operational team who will work alongside the CI/PI to project manage the study. The CI/PI needs then to establish the Study Project Team and Study Management Group, and set the work plan and timeline for completing the study. All studies involving new data collection are required to complete a Study Support Template (SST) (Study Support Template and Guidance Notes for SST Process), which will need to be submitted to the CTU Governance and QA Officer, to ensure that the study’s resource and timeline requirements match what was originally agreed at the CTU sign-off stage. If new staff are to be appointed to the CTU or iPCHS or HSRU from the grant, the PI will need to liaise with the iPCHS Business and Finance Manager to prepare the job description and person specification, to ensure a Post Approval Request is submitted, and then to follow the University recruitment process to appoint the new member of staff. Please note that the process of recruiting new staff can take a number of months so plan early. 3.7.2 Study Sponsorship Arrangements for CTIMPs See SOSOP1 Applying for Sponsorship See POO1 Sponsor Oversight Framework See POO2 Sponsor Management Framework Once funding has been confirmed, the Study team will need to plan the delegation of sponsor functions and prepare their submissions for regulatory approval, by developing their detailed protocol and associated paperwork. For CTIMPs the HRA Standard Protocol Template should be used. 3.8 Grants Submitted in Collaboration with External Institutions

Aspects of this SOP also apply to research grants which are led by other institutions, but include collaboration with Keele staff / CTU. The key aspects of this procedure to follow when staff are involved in collaborations led by other institutions include:

CTU engagement and adoption processes

Research costing

Sponsor in-principle approval (if Keele is to be sponsor)

After grant submission

Contracting arrangements

3.9 Sharing of Research Data with Collaborators Where a successful grant application involves access to and use of collaborators’ research data (this does not include commercially available data sets, e.g. GPRD, HES, Health Survey for England), then the PI will need to complete the collaborator’s permissions documentation. A nominated Data Custodian from within the Study Team (normally the Statistician for quantitative data and the Lead Social Scientist for qualitative data) must be identified. The Head of CTU IT Systems must be involved in allocating space for the data on the CTU’s secure IT Network.

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A record of the data brought in to the RI must be made on the appropriate form (Record of External Data held at iPCHS) All data brought in to the RI must be stored and used in accordance with the RI’s sensitive data policy (Procedures for Data Security & Managing Sensitive Data), SOP 16 Analysis and SOP 17 Archiving and Destruction.

4. Key Personnel to whom this SOP Applies All staff planning to work in collaboration with the Keele CTU should familiarise themselves and comply with this SOP. 4.1 PhD Supervisors and Students Postgraduate supervisors are responsible for ensuring their PhD / MPhil students follow CTU SOPs if their studies involve submission of grant applications or recruitment of patients for their research.