RESEARCH & DEVELOPMENT

PROJECT REGISTRATION FORM

GUIDANCE NOTES (v2.0)

1.GUIDE TO REGISTRATION PROCESS
Please confirm that you are using the correct version of guidance for the registration form you are completing. This guidance accompanies version 2.0.
The R&D Office is committed to reducing approval times where possible and researchers can assist in this process by providing fully completed forms and documentation. This guidance aims to help you to do this and you are advised to familiarise yourself with what is needed and to seek advice or further guidance from the R&D Office where necessary.
Following a recent review of the approval process, applications are now considered in ‘batches’ at an project registration meeting with those involved in approving studies. It is anticipated that this will streamline the approval process and reduce the time to approval. Trust approval for research is coordinated by the R&D Office with final approval being signed-off by the Trust Chief Executive. Therefore, Trust approval has not been granted until such signed approval is in place and no patient recruitment may occur until this is complete.
Monthly meetings of the R&D project approval group are scheduled. Applications received that are fully complete two weeks in advance of the date of this meeting will be considered – those received within the preceding two weeks of the meeting will be considered at the next meeting. Details of these cut-off dates are available from R&D. Prior to the meeting the projects will be reviewed and any routine queries dealt with where possible. At the meeting a decision on the project will be reached as either:
-Recommend to approve
-Recommend not to approve
-Further clarification/information required.
PIs will be contacted within the two weeks following the meeting with the outcome of their application.
As we all know it has become increasingly complex and confusing as to which approvals need to be applied for before others. The Trust will no longer provide provisional approval, or approval subject to Ethics or MHRA as outlined in the old Trust approval letter. Therefore it is now a requirement of final R&D approval that we have evidence of these other approvals. Ideally you should apply for ethics, MHRA or other approvals at the same time as applying for R&D approval so that all these applications can be done in parallel – you do not need to wait for other approvals prior to submitting your project registration form to R&D. Please note that if you require confirmation of sponsorship from the Trust (for example for a Funder or MHRA) we can provide a letter which states that we will act as sponsor ‘subject to our full R&D approval process’.
If you have queries about information needed for completing the form, please contact the R&D office on Trust.R&. Please note that the form is designed to be completed electronically and the boxes will automatically expand where necessary. If you are having a technical problem completing the form (e.g. cannot tick a box, or a box does not expand as necessary) please contact Caroline Hodgson on .
2.STUDY DETAILS
Please provide a full, accurate title as this is frequently used when cross-matching documents etc for the appropriate file. Consistency in this will reduce errors when cross-referencing and updating project files in the R&D office.
3.PRINCIPAL INVESTIGATOR
Under the Research Governance Framework, the Principal Investigator (PI) takes responsibility for the research within this Trust. We will only accept someone as a PI who has a substantive appointment in an NHS Trust or Higher Education Institution.
4.RESPONSIBLE CLINICIAN
If the PI is not a consultant or senior clinician in the Newcastle upon Tyne Hospitals NHS Foundation Trust, please identify a senior responsible clinician for the study who is in such a position.
5.FUNDER INFORMATION
We will not process registration forms until funding is in place, or in place in principle. We therefore suggest that you do not submit your registration form until this is the case. However there will be occasions when you need to submit this registration form e.g. for the purposes of a funding application where you need to give a reference number.
6.SPONSOR INFORMATION
Under the Research Governance Framework, the Sponsor takes responsibility for ensuring the correct approvals for the research have occurred, that quality research is undertaken, and that the research is managed appropriately. The sponsor is not necessarily the funder. However, in commercially funded studies the sponsor is often the commercial organisation (eg, large drug company) funding the work. For non-commercial/academic studies it is usually the main NHS organisation. If the proposed sponsor is not Newcastle upon Tyne Hospitals NHS Foundation Trust a sponsor agreement letter is required.
7.CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS
Is your study a clinical trial of an Investigational Medicinal Product (ctIMP)?:
The EU Clinical Trials Directive includes all interventional clinical trials involving Investigational Medicinal Products (IMPs) for human use where the aim is to test the safety or efficacy of the product. The term ‘medicines’ embraces all kinds of medicinal products, including pharmaceutical and biological medicines, vaccines, herbal remedies and homeopathic products. The official definition of a ‘medicinal product’ as provided by the Medicines and Healthcare products Regulatory Agency (MHRA) is available at:

the actual algorithm and linked question is Q8, on pages 7-9 of this document which you are strongly advised to check.
If your study is a ctIMP then a Clinical Trial Authorisation (CTA) is required from the Medicines and Healthcare products Regulatory Agency (MHRA) – see: You must also register your study with the European Clinical Trials database (EudraCT) at and obtain a unique EudraCT Number which must be recorded on all documentation. This number is required before a submission can be made to MHRA.
If you are unsure please whether your study is a ctIMP you should not contact MHRA yourself but go through Newcastle Clinical Trials Unit who will do this on your behalf. They will be able to provide advice in the first instance based on previous experience and be able to present your case to MHRA with the full information required. Contact details can be found at
If your study has a commercial sponsor then it would be expected that they would monitor the study in accordance with GCP guidelines. If the Newcastle upon Tyne Hospitals NHS Foundation Trust is sponsor then it is the Principle Investigator’s responsibility to organise monitoring. This can be arranged through the Newcastle Clinical Trials Unit – for advice please contact them directly at They will also advise on the necessary costs to be included for the monitoring needed for a particular study.
8.END OF TRIAL TREATMENT INFORMATION
Please supply the information required including details of e.g. any end of trial drug will be funded if appropriate.
9.TISSUE SAMPLES
The Human Tissue Act provides a legislative framework for issues relating to whole body donation and the taking, storage and use of human organs and tissues. It sets out the requirement to obtain appropriate consent to carry out activities regulated under the Act including: storage and use of whole bodies; removal, storage and use of human material (organs, tissues and cells) from deceased patients, and the storage and use of material from living patients. If your research includes the use of human organs or human material you should check the requirements of the Act as it relates to your research. Please note however that cell lines are excluded from this Act. Where tissue is being transferred between Institutions, a material transfer agreement will need to be in place (arranged via Trust R&D). If you are at all unsure or need further guidance please contact Trust.R& in the first instance.
10.DATA PROTECTION / CALDICOTT ISSUES (please see notes)
Guidance for this section is currently under development. If you have any queries in the meantime please contact Trust.R& in the first instance for forwarding to the relevant person.
11.FINANCIAL INFORMATION
You should note that the way funding of clinical research is organised is undergoing change. For example, NHS service support costs will usually be recovered through the Local Research Networks. All excess treatment costs should be included and these must be discussed with the relevant Clinical Director(s). Costs that are not relevant to The Trust do NOT need to be included (e.g. those that are already included on blue form for NewcastleUniversity).
You should provide supplementary documentation wherever necessary to show how you have arrived at your costs. This may be an excel spreadsheet showing your calculations, however, we will accept supporting information in the most appropriate manner for each application.
You are advised to consult the Department of Health ‘Attributing revenue costs of externally funded non-commercial research in the NHS’ document (ARCO) for an overview of how costs are categorised. This is available at:

12.CHIEF INVESTIGATOR
These sections need only be completed if you are NOT submitting an NRES form (formerly COREC form) to R&D alongside this registration form.
13.PATIENT/SAMPLE INFORMATION
If approval is given, it will be for the stated number of samples/patients. Recruitment to a project/trial is required to stop when the maximum number of participants (patients and control participants if relevant) has been reached. You MUST contact R&D before recruiting any patients over and above this number.
14.SUBMISSION CHECKLIST
Applications should be accompanied by all those documents listed as ‘necessary’. Your registration will not be logged (and therefore will not enter into the approval process) until all of this documentation is received. Part applications will not be considered and date of receipt of your project will be recorded on the date that the last required document is received by the R&D office.
Some documents (under “to be forwarded”) may not be needed, or can be sent through to the R&D office once they become available during the application period.
If sending subsequent documents, or sending documentation by email please use the Trust project registration number wherever possible as this will reduce delays or errors in reconciling these against the correct project. If submitting document electronically please address toTrust.R&d state the Trust project reference number (if known) AND the PI/full project title.
15.PRINCIPAL INVESTIGATOR SIGNATURE
The PI is responsible for running the study in accordance with the Research Governance Framework for Health and Social Care (available at ).
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