Frequently Asked Questions (FAQs)
↓ Confidentiality Agreements
What is a Confidentiality Agreement (CDA)?A CDA is a legal document which forms a contractual agreement between two or more parties by which all involved agree to an obligation to keep a confidential relationship in regards to the information which is included, which often includes sensitive, technical or commercial information.Who is authorised to sign a confidentiality agreement on behalf of the Trust?This can only be signed by an authorised signatory within the Research and Innovation Department. Further details can be found within the guidance contained within the following document: confidentiality agreements guidance.Click here to download the CDA presentation
↓ Clinical Trials Agreements
What is a Clinical Trials Agreement (CTA)?A CTA is a legal document which forms a contractual agreement between two or more parties.
- Bespoke/Model Agreements/Commercial Agreements
- Financial information/Invoice/Pharmacy details
↓ Performance
Where can I find information about how my study is performing against its recruitment target?
The Research and Innovation Department provides a research dashboard where you can find performance information on all research studies being conducted in the Trust. This uses data directly from our research database, EDGE.
Click here to visit our Research Dashboard (only available via the Trust intranet)
↓ EDGE - Research Management System
What is EDGE?EDGE is the primary Local Portfolio Management System (LPMS) for the Leeds Teaching Hospitals NHS Trust (LTHT) used to record all research activity that takes place within the Trust.EDGE is a web hosted system that can be accessed from any web enabled device; EDGE is also being used by some staff at the University of Leeds (UoL) as you do not have to be on the Trust network to access EDGE.How do I gain access to EDGE & Access training?To gain access to the EDGE, you must attend one of our training sessions that are available across our main sites (St James University Hospital & Leeds General Infirmary). Currently training is only available to employees of the LTHT and UoL.You can book onto training via the Research Academy page:http://www.leedsth.nhs.uk/research/research-academy/What do I have to do on EDGE for the studies I am working on?If you are working on a research study on a clinical or non-clinical capacity, it is your responsibility from when the study opens to ensure;
- at least 2 people have access to update the study record and that staff are providing regular updates through the notes function.
- the study details (e.g. planned recruitment end, site target, study contact) are kept up to date
- ALL activity is logged in EDGE. This includes patients that have been;
- pre-screened (e.g. this could be looking at a clinical list)
- approached (even if they declined, this is activity!)
- consented (even if they didn’t meet the eligibility criteria, this is work you have done!)
- Recruited – extremely important that we enter patients that have been recruited onto EDGE the same day or at the very least the same week.
For further information, email leedsth-tr.EDGE@nhs.net
↓ Research Passports
What is a Research Passport and who needs one?A Research Passport is the mechanism for non-NHS staff to carry out research in the NHS. The research passport form is completed by the researcher with their university/employer and is checked and validated by the proposed associated NHS organisations.Click here to view further informationWhere can I find the Research Passport form?The research passport form can be found on The National Institute for Health Research (NIHR) website as the NIHR have produced guidelines for researchers to be compliant with.Click here to view the guidelinesWill I require a Letter of Access (LOA) or an Honorary Contract (HRC)?Typically, an HRC is issued when a researcher’s activity has a direct bearing on the quality of patient care.If you check your proposed research activity using the NIHR algorithm this will tell you exactly which you will be granted and also provides information on which pre-engagement checks will be necessary for your application.
Click here to view the NIHR algorithmHow long will it take before my LOA/HRC is granted?This can vary dependent upon a number of factors. If the form has been correctly filled out by both the researcher and the HR university/employer and is submitted with all pre-engagement check proofs, then as long as there aren’t any amendments to be made it can be processed straight away. The proposed NHS sites check and validate the form in the R&D office before sending to the Trust Human Resources (HR) for final validation, who then complete the request and issue the document.
Click here to view the NIHR algorithmHow long will it take before my LOA/HRC is granted?This can vary dependent upon a number of factors. If the form has been correctly filled out by both the researcher and the HR university/employer and is submitted with all pre-engagement check proofs, then as long as there aren’t any amendments to be made it can be processed straight away. The proposed NHS sites check and validate the form in the R&D office before sending to the Trust Human Resources (HR) for final validation, who then complete the request and issue the document.
↓ General Frequently Asked Questions
My study has HRA approval, what do I do next?Guidance on what documents to submit to the R&I Department and how to gain confirmation of local capacity and capability is below;Where LTHT will be the sponsor of your studyIf you wish to submit your study for Confirmation of capability and capacity and Leeds Teaching Hospitals NHS Trust (LTHT) will be the research governance sponsor, please contact the R&I Office and we will help you with your submission to the HRA and advise you on getting confirmation of capability and capacity at LTHT and in your participating sites.What other approvals do I need to send to you?E.g. CSU, finance. Once you submit your local information pack to the R&I office, it will be allocated to a team member who will review and guide you in what support department approvals are required. What is the process for archiving old study documents?What is the process for archiving old study documents? If you have an old study which is ready to be archived you should refer to the study SOPs.Click here to download the archiving SOPWho should I notify if there is a change of principle investigator or an amendment needs to be submitted?If the local team change here in LTHT, please notify the R&I department and you must notify the sponsor who will advise if this change needs reporting to the REC/MHRA. Who do I notify if there is a serious adverse event (SAE) on a study I am working on?If there is a SAE or other incident which happens on the study then you must follow the Incident Reporting SOP which is available on the intranet.Click here to download the SOP for CTIMPs
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