Initial Concept to Submission
Clinical Trials Links
The Sponsor is an institution or organisation that takes on the legal responsibility for the initiation and management of the research study, but is not necessarily the funder. You will need to identify an institution that is willing to take on this role, regardless of whether or not it is a Clinical Trial. Many of the main funding bodies are willing to provide grants for research, but are not able to take on the responsibilities of Sponsor.
The OUH Trust is willing to assume Sponsorship of a research study when it is appropriate to do so: usually when a OUH Trust employee has designed the study and is acting as the Chief Investigator. In any situation, the OUH Trust must actively consent in writing to acting as Sponsor of a study.
Sponsorship of a Clinical Trial (or aspects of a trial) carries with it the legal responsibility to ensure compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004 and Amendment 2006.
If you would like the OUH NHS Trust to act as the Sponsor for your trial it is important that you approcah the R&D Department at the earliest stage of your Clinical Trial Protocol development.
The process leading up to the acceptance of sponsorship by the Trust includes the R&D Department being involved in:
At the same time the R&D Finance Team will advise on costing the trial, and any agreements and contracts can be negotiated and drawn up on your behalf.
Early planning will make compliance with the Regulatory Framework much less daunting and onerous.
Specific Funding Requirements
You should contact R&D Finance as early as possible. If your study is a Clinical Trial, there may be additional costs to be incorporated into your funding application. For example:
Clinical Trial Protocol Development
A Clinical Trial Protocol is a document that describes in detail the objectives, design, methodology, statistical consideration and organisation of a trial. The Clinical Trial Protocol is one of the essential documents required for a Clinical Trial and it is important that this is developed early on in the study preparation process. Although you may have prepared a Clinical Trial Protocol during preparation for funding application, there are additional aspects that you need to consider for a Clinical Trial. R&D have produced a generic SOP Template: Study Protocol Development and Review (Template 12) which can be adapted to suit the Clinical Trial Protocol development and review process for your particular trial or department.
One of the first requirements that must be addressed is to ensure that the Clinical Trial Protocol complies with the requirements of the Regulations. If you do not have a GCP compliant Clinical Trial Protocol template of your own you can use the R&D Clinical Trial Protocol (Template 17). This has been designed to ensure that all aspects of the trial procedures have been considered. The R&D staff are happy to review your Clinical Trial Protocol for compliance and to give advice where it is needed.
Alternatively, you can refer to Section E6 of the ICH GCP Guidelines [PDF document] for an outline of the requirements.
Once your Clinical Trial Protocol and essential documents have reached the final stages of development, you will be ready to obtain the necessary approvals: ethics approval, a Clinical Trials Authorisation (CTA) and, if you are involving NHS patients or using NHS facilities, Trust Management Approval (R&D Approval). Before applying for these, you will need to obtain a EudraCT number. EudraCT is the European Clinical Trials Database of all clinical trials commencing in the European Community from 1 May 2004 onwards. Each clinical trial with at least one site in the European Community, receives a unique number for identification, the EudraCT Number. You can do this online here.
All Clinical Trial Protocols need independent peer review. Major funding bodies often undertake this as part of their acceptance procedure. If your study is not funded by such a body, you will need to identify an independent peer to undertake the review.
More information is available on the Peer Review page.
RDS South Central can provide stattistical review support for NIHR Portfolio studies. See the Peer Review page for contact details
All Clinicial Trial Protocols using medicines have to be reviewed by the Clinical Trials Pharmacist as early as possible in the development process. For trials at the OUH Trust please contact Pharmacy by email at email@example.com or by phone on 01865 (2)57860.
You will need to employ some form of document control throughout the review procedure. R&D have an SOP Template: Document Control (Template 07) which can be adapted to suit your study or department.
The safety section is one of the most important aspects of a Clinical Trial Protocol. The approach to patient saftey during a clinical trial needs to be rigorous and well-documented in the protocol.
It is essential that hte whole study team are familiar with the safety reporting requirements for Clinical Trials.
In both these cases, if this is clearly stated in the Clinical Trial Protocol and approved by the MHRA and Research Ethics Committee (REC), then the safety reporting procedures involved in trial conduct can be much less onerous, but remain safe. The safety section in the Clinical Trial Protocol (Template 17) and Trust Safety Reporting Policy on the Policies page will give guidance on this and the R&D team are happy to advise. There is also a Saftey Reporting SOP Template to be used for all hosted Clinical Trials: Safety Reporting Responsibilities and Processes (Template 11).
Participant Information Leaflets and Consent Forms
It is important that the information given to participants, prior to obtaining their written informed consent to take part in the study, is clear and concise. NRES provides detailed guidelines on the production of this document.
Use of these guidelines will avoid unnecessary delay when you come to submit your study for ethics approval. They are updated from time to time, so it is important that you are following the current version.
For all ORH hosted studies please add the OUH NHS Trust Header to the Participant Information Leaflet, Informed consent form, GP letter and advertisements (if applicable). Your Sponsor may also ask to have their logo or header included.
Insurance and Indemnity
Insurance and indemnity is required for all clinical research and is provided by the sponsor. A clear statement of who is providing cover and under what circumstances should appear in the Clinical Trial Protocol, the Participant Information Sheet and Ethics Application Form. The R&D department can advise. For studies sponsored by the OUH NHS Trust the following form of words should be used:
If your study is sponsored by a commercial company or non-commercial organisation they will be responsible for providing indemnity.
Clinical Trials Authorisation (CTA)
All studies falling into the category of Clinical Trials will require authorisation by the Medicines and Healthcare products Regulatory Agency. Application forms can be accessed online. You will need to pay a standard fee with this application. For details see the MHRA website [PDF document].
Read the detailed guidance on how to apply for a CTA. A SOP Template: Preparation of a Clinical Trial Authorisation Application (Template 26) is also available for your use. Should you need assistance in completing this form; the R&D staff will be happy to advise you.
It is in your interest to get the application right first time, since a request for further information from the MHRA will slow the procedure considerably. In extreme cases, if the application is refused, even because of inadequate information being submitted, you may have to pay another fee when resubmitting (this could be £252 - £4,040).
The ethics application form can be generated from the IRAS site.
It is a web-based form and can be worked on repeatedly prior to your submission. You will need to submit this form to R&D when obtaining Sponsorship approval, but we advise that you download it without locking it to enable you to make any changes to the form on the advice of R&D.
Clear guidelines are provided within IRAS on how to complete this form and, should you encounter any uncertainties or difficulties, the R&D staff will be happy to give you advice.
Documents you will need are itemised on the front of the form. These include:
Once you have had your application form signed, approving Sponsorship, you should be ready to submit your ethics application. You will need to book a slot for review by the relevant ethics committee. To do this you should be sure that you would be ready to submit your documents within a four-day time window. For details please refer to the NRES guidelines.
R&D has produced an SOP Template: Ethics Committee Application (Template 27) which can be adapted to suit your particular trial or speciality.
If your Clinical Trial involves gene therapy, you need to obtain approval from the NRES committee, London-West London and Gene Therapy Advisory Committee (GTAC). For more infomation, access this link: new-arrangements-for-the-gene-therapy-advisory-committee
NHS Trust Management Approval
If your study involves recruitment of patients from within one of the NHS Trusts, or uses Trust facilities, you will need to have NHS Trust Management Approval (R&D approval). This will be done either through the Coordinated System for obtaining NHS permissions (CSP) or vial the R&D office. Please see the Trust Management Approval page for more information.
More information on Trust Management Approval.