Request for Research Sponsor Form
It is a requirement that all research activity in the NHS has a Sponsor. It is important that an approach to the appropriate organisation is made at the earliest possible opportunity.
If you would like UHL to consider acting as Sponsor for your research activity, please complete the following proforma, and send it, along with supporting documentation for the attention of Carolyn Maloney, using .
The University Hospitals of Leicester follow a process of review to aid the final decision. Please note, that a period of not less than 14 days must be allowed for the initial Sponsor review. You must not submit your study to a Research Ethics Committee, the HRA, or to any other Regulatory body until you have received confirmation in writing (usually by email) that the UHL have agreed ‘in principle’ to Sponsor the proposed activity.
Full title of StudyIRAS Number
Short Title of study (including acronyms)
Name of Chief Investigator (CI) / Name of substantive employer (where does your pay slip originate)
Address (at work)
Telephone No.
Mobile & Landline
Email address – the one you access most and will use during the course of this research
Category of Research – taken from IRAS / ☐Clinical trial of an Investigational Medicinal Product
☐Clinical investigation or other study of a medical device
☐Combined trial of an investigational medicinal product and an investigational medical device
☐Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice
☐Basic science study involving procedures with human participants
☐Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology
☐Study involving qualitative methods only
☐Study limited to working with human tissue samples (or other human biological samples) and data (specific project only)
☐Study limited to working with data (specific project only)
☐Research tissue bank
☐Research database
If your work does not fit any of these categories, select the option below:
☐Other study
Name / Address of main funder – the organisation providing financial support for the research
Details of main contact for funder. Please include contact name, email address and phone numbers
Amount of funding / Financial: £ In Kind: £
Which organisation will receive the funding?
Name and contact details of academic support (if a student project)
Please estimate the numbers of volunteers participating in the whole study:
Minors * / Adults
Patients
Healthy Human Volunteers
*Minors are those under 18 years of age.
Is the study Single Site or Multi-Site? Please list proposed additional sites if Multi Site. Please note, research within UHL (3 hospitals) is viewed as Single Site.
Will any of the research activities be conducted in any of the following? / Loughborough Hospital / Hinckley Hospital
Market Harborough / Coalville
Fielding Palmer / Oakham
Melton Hospital / East Midlands Sports &
Exercise Medicine Centre
Does the study involve any novel invasive procedure? / ☐Yes ☐No
If so please describe
Are you proposing to use any support services within UHL:
☐Imaging ☐Laboratory Services
☐Cardiac Investigations ☐Medical Devices,
☐Nuclear Medicine, ☐Ophthalmology,
☐Audiology ☐Medical Illustration
☐Orthodontics, ☐Radiotherapy.
☐Respiratory Services
If so, please give details:
Will you be using equipment for the research that is not already within the hospital? – ECG Machines, BP Monitors, Electronic Temperature monitors (patient), Fridges, Freezers etc.
☐Yes ☐No
If so, please give details.
Will you be requesting that samples are released for you to use from a Tissue Bank facility? / ☐Yes ☐No
If so, please give details
Have you / are you planning to engage with a statistician? Please give details / ☐Yes ☐No
Please give details of statistical support and the name of the provider
Are you using external services to support any aspect of your research – external means any service NOT provided at UHL and includes University of Leicester & Leicester CTU
☐Yes ☐No
Please give details of service and proposed provider
Data Asset, Collection and Information Flow Mapping Questions
Question / Expansion / explanation of question / Researcher Response / Sponsor Comment
(Office use only)
What type of database/s will be used? / Please give details of all database or data collection tools that will be used during the study. This includes any paper or electronic tools and any statistical analysis tools to be employed.
Is/are the database(s) / data capture tools bespoke or off the shelf? Please give full details. / Are you planning to develop your own data collection tools using generic programmes available through your ICT Platform (e.g. Excel), or will you be subscribing to use a licenced product or purchasing software to install on your computer? Please give details.
Is the data capture tool listed as an Asset on the UHL Data Asset Register? / Is the data capture tool / database listed on the UHL Data Asset Register? If so, please provide the reference number
Where is it held? / Where will the data tool be held? Will this be on UHL Desk top computer or laptops / via internet access etc.
Who owns the user licence for the database? / If you will be purchasing a new user licence for the data tools, who will the ‘owner’ of the licence be? What is the name of the director of the organisation that ‘owns’ the software. If you plan to use existing software, where is the licence held? Who ‘owns’ or is responsible for the renewal of the licence and the controller of the licenced product within UHL?
Who is the data capture ‘go-to’ person at UHL / Who will be responsible for queries / issues relating to the database at UHL?
Is access to the data restricted? / Who will have access to the database? Will access be restricted? How do you plan to restrict access?
How are staff trained to use the system? / Please provide details of how the training will be delivered and by whom.
Are there defined access controls? / Is there functionality within the system to show who has access?
Does Remote Access to the system (s) exist? / Can the system(s) be accessed remotely to UHL? If so, how is this achieved?
Is 3rd party access allowed? / If UHL are not the owner of the system(s) the answer to this question is N/A.
If UHL is the owner and access to 3rd parties has been provided the answer is YES
Question / Expansion / explanation of question / Researcher Response / Sponsor Comment
(Office use only)
Are there validation processes in place? / Do you have a validation process in place? If not who will be conducting validation of the data? How will you ensure that what you are putting into the data tools is correct? UHL as sponsor recommend a minimum of 10% validation which must be increased if errors found are above 10%.
How frequently will validation take place? / Who will conduct validation and how frequently? Ideally this needs to be someone separate from the research team but could be a collaborator.
Who will manage data queries? / If data cleansing / validation identifies issues, who will be responsible for addressing the queries? This needs to be clear on the Delegation of Authority and Signature Log for each study.
How will data cleansing be carried out? / Do you have a plan for data cleansing? Who will be carrying out data cleansing and how frequently?
What QC measures are in place? / What quality control measures are in place to assure the quality of the data is consistent? Who will conduct the quality control checks? NB if study small – could be included in provision for validation processes.
Does a Confidentiality Agreement exist? / Does a Confidentiality Agreement exist between the system owner and the Data Owners.
Other HCP Social /Care access – name protocol / Is there an Information sharing agreement between UHL and HCP Social Care?
Registration / Deregistration / Please describe the registration process that allows individuals to access the system(s). Is access provided via a username or email log-in. Are user accounts password protected etc, Also please describe if any processes are in place to deregister individuals’ access to the system(s)
Define the Password Strength / What is the minimum allowance for Password strength? Please define whether or not passwords require upper, lower case and numbers etc.
Mobile Equipment / Is any mobile equipment used e.g. USB Sticks etc
If Multi-Centre – who will provide support to sites & manage data queries? / Validation, QC, data queries etc. will all need to be managed at the separate sites. How will this be managed? Who will manage these processes? What support will be given to sites in respect of the use of the data tools?
Has the CRF informed the database? / In some circumstances the database will be informed by the CRF but in others it will be the reverse. How will you reflect sections in the CRF within your data tool? You will need to consider this specifically when purchasing off the shelf tools.
Is the CRF Electronic or paper form? / Is the Case Report Form electronic or paper?
Question / Expansion / explanation of question / Researcher Response / Sponsor Comment
(Office use only)
Who will complete the CRFs/e-CRF / Who will complete the CRFs?
Is identifiable data being stored outside of the NHS? / It is fine to store identifiable participant data outside of the NHS provided that your participant has explicitly consented for this. The clause in the consent form must be clear that their data will be stored at XYZ University or other facility.
If yes, does the consent form give explicit consent for this? / Remember that a consent form is a piece of identifiable participant data and consideration must be given for the long term storage of these forms at the end of the study. Again – ensure that there is an explicit clause in your consent form.
What will source data comprise of? / What will comprise source data?
Will the data be sent internally, externally or both? / Will data be sent within UHL Only (Internal), UHL to UoL or other organisations outside UHL (External) or both
Is the data custodian different to the CI? / If the data custodian is different to the CI please give an explanation as to the reasons behind this.
What is the definition of the Data? / NonPCD – Non identifiable
PCD1 – data is identifiable (Patient and Staff) but only contains non sensitive information such as name, DoB, address etc.
PCD2 – data is identifiable but contains information that is sensitive (ethnicity, religious belief etc.)
Where will the enrolment log be held? / Please describe the storage arrangements for the enrolment log. Please include provision for enrolment logs held at other sites.
Specific Location of Originating Data? / Where does the data originate from? This description should include the physical location of data collection (e.g. department, clinic etc.) and also how the data has been derived (e.g. patient notes, a self-complete questionnaire etc.).
Is it Bulk Data? / Bulk data is defined as more than 50 occasions of data instances. All data collected in relation to an individual participant would class as one instance of data.
Purpose of Transfer / This field should be populated with “As per research protocol”. Please select from the drop-down list.
Specific Location of Destination for Data / This is the physical location of where the data will be sent. Please provide as much information as possible, considering the following: department, clinic, named office, etc. Please also include the name of the data custodian.
Question / Expansion / explanation of question / Researcher Response / Sponsor Comment
(Office use only)
Legal Cover for Flow / By what means do you have the authorisation to collect this data?
· Patient Consent
· Legal Request
· Section 251
· Public Interest
· N/A
How is data sent / For any data that is sent either internally or externally, please select all means of data transfer that apply.
Where will the master list of participant study numbers be held? / Will the master list hold details of participants recruited from other sites? Where will the master list be held? NB the Master List will contain information about screen failures as well as those patients enrolled into the treatment arms.
Is there a backup of the database or system restore protocol? / If a database is to be held on a drive within a UHL system then it is likely that this will be backed up. If the database is provided through an internet connection, please describe the backup facilities in place.
Is there a disaster recovery plan in place? / If a database is to be held on a drive within a UHL system then it is likely that this will be included in the UHL ICT disaster recovery plan. If the database is provided through an internet connection on a remote server, confirmation that disaster recovery provision is in place must be received.
Where will analysis of the data take place? / Where will the analysis be physically carried out? By who?
How will the data be archived at the end of the study? / How long to you plan to archive the data at the end of the study and for how long?
Does length of storage of data comply with sponsor policies? / Do your plans comply with UHL Archiving policies?
Is the data team included in protocol amendment discussions and implementation? / How will you ensure that the data team are included in any amendments to the protocol during the lifetime of the study?
To be completed for Clinical Trials of Medicinal Products Only
Clinical Trials of Investigational Medicinal Product / Which phase category does the study fall into?
☐Phase 1
☐Phase 2
☐Phase 3
☐Phase 4
If CTIMP study – Are you receiving IMP from a Commercial Provider? / Please give details of provider and products:
If CTIMP study - Have you engaged with Pharmacy? / ☐Yes ☐No
If so, please give details of Pharmacy Contact at UHL:
What provisions are in place for prescribing / continuing medication post study? / Please give details.
Question / Expansion / explanation of question / Researcher Response / Sponsor Comment
(Office use only) / Risk RAG Rating
(Office use only)
When will data lock occur? / When do you plan to conduct data log- do you have a plan for data lock?
When is data release expected? / When do you plan data release?
Is there a data management plan and who wrote it? / Is there a data management plan and who wrote it?
Please send all documentation to be reviewed by the Sponsor to . A review will not commence until a full minimum data set is received.
Minimum dataset includes:
· Full IRAS Dataset (.pdf)
· Latest version of Protocol (word format - on UHL Template – See SOP S-1021 UHL)
· Latest versions of all Patient documentation – include ICF, PIS, letters etc.
· Evidence of Peer Review – See SOP S-1002 UHL
· Evidence of Finance approval – See SOP S-1034 UHL
· Latest versions of GP Letters (where appropriate)
· Copy of All data collection forms – CRF etc.
· Copy of Completed DATA / CRF Questionnaire
· CV of Chief Investigator
· Evidence of relevant training of Chief Investigator
List of Documentation submitted for Sponsor Review
Name of Document / Version Number / Date of Document
Please add rows as necessary