A whole new study
In addition to the information on the Setting up a Study page, the following is relevant where the study is wholly new:
- How can I establish the Sponsor Organisation?
- How does the study get site approval?
- How can the study be registered on a public website?
- The study is definitely a CTIMP/ATIMP: is there anything additional to do?
How can I establish the Sponsor Organisation?
Study Sponsorship
The Research Governance Framework for Health and Social Care states that all research projects must have an identified sponsor. Any organisation which funds, initiates, hosts research or employs staff involved in research can be a sponsor, such as:
- The funding body may be willing to sponsor. However, many charities and public bodies are reluctant to act as the sponsor either because of the volume of research they support or their limited infrastructure.
- Commercial companies.
- Approach your substantive employer (for the research part of your contract)
- Students should contact their University: as a general rule (with some rare exceptions), student research will be sponsored by the University the student is registered with.
Although there are exceptions, the JRMO follow the rule that the sponsor is the Chief Investigator’s substantive employer.
What do I do if I want Barts Health or Queen Mary to sponsor my study?
In order to consider your application, we will need to receive and review all the documents that you intend to submit to regulatory bodies, in their draft form. Please see below for comprehensive guidance about the documents required including how and when ready to submit. All applications for sponsorship should be sent to research.governance@qmul.ac.uk
Applying for sponsorship from Barts Health or Queen Mary
As a minimum dataset for all studies you should submit the following:
- Research Protocol: on JRMO template for a research study, interventional study or MHRA-regulated study, as applicable
- Completed draft IRAS application form (Integrated Research Application System)
- All participant documentation, examples of which are: Participant Information Sheets, Consent Form, GP letter, questionnaires, interview schedules/guides
- Review of research including Peer review and Departmental authorisation
- Signed Conditions of Sponsorship Agreement
- Chief Investigator's CV
In addition to the minimum application pack listed above, for CTIMP studies you should also submit a copy of the Clinical Trials Authorisation (CTA) from the Medicine and Healthcare products Regulatory Agency (MHRA).
Research Protocol
The Research Protocol forms an essential part of any research project. It is a full description of the research study and will act as a ‘manual’ for members of the research team to ensure adherence to the methods outlined. As the study gets underway, it can then be used to monitor the study’s progress and evaluate its outcomes.
No two research protocols will be the same, but they will have a similar structure:
- title
- abstract/summary
- background or rationale of the project
- aims / objectives
- experimental design and methods (including statistical analysis)
- ethical considerations
- benefits of the study
- resources and costs
The protocol should go into as much detail about the research project as possible, to enable the review bodies to fully understand your study. For studies applying for sponsorship from Barts Health or Queen Mary, researchers must complete the JRMO template for a research study, interventional study or MHRA-regulated study, as applicable.
Integrated Research Application System (IRAS)
The Integrated Research Application System (IRAS) is the method by which you submit applications for sponsorship, REC, HRA, MHRA and other approvals. It is a single, integrated, web-based research application system.
It has been designed to capture the information required to conduct health and social care research in the UK. Based on the answers given by the researcher in the Project Filter page, the system ensures that the information collected is appropriate for the type of study, approvals and permissions required.
The IRAS form captures the information required by, and is the only method by with to apply to, the following review bodies:
- Administration of Radioactive Substances Advisory Committee (ARSAC)
- Confidentiality Advisory Group (CAG)
- Gene Therapy Advisory Committee (GTAC)
- Health Research Authority (HRA) for projects seeking HRA Approval
- Medicines and Healthcare products Regulatory Agency (MHRA)
- NHS / HSC R&D offices
- NHS / HSC Research Ethics Committees
- National Offender Management Service (NOMS)
- Social Care Research Ethics Committee
It is also the method by which to apply for eligibility assessment and acceptance on the NIHR Portfolio.
If you are unsure about when and whether IRAS application is required, please email research.governance@qmul.ac.uk
Review of Research (including Peer review)
For studies we sponsor, we will need to see evidence of a review of the quality of the research and the ‘protocol’, and a review to establish the resource and financial implications of the research activity for the institution and department, including strategic fit and the use of available resources.
For more information about who can conduct a review and how to submit for reviews, please see our SOP 14.
Supporting Documents
There will be additional documents for you to complete but these depend on the nature and scope of your study. Please refer to the IRAS Checklist Tab for a full list and the JRMO Document Checklist.
How does the study get site approval?
The HRA expects study sponsors to invite potential participating sites by providing at least the study protocol as early as possible. It gives prospective sites the opportunity to know the basic detail about the study, time to access requirements and communicate back to the study sponsor whether a site would be interested in becoming a participating site. As the HRA expects sponsors to formally invite sites, it is very important for a prospective site to know who is or will be the study sponsor.
How can the study be registered on a public website?
Obtaining Clinicaltrials.gov registration
It is Government policy to promote the registration of clinical studies and give the public access to research findings affecting health and social care.
The HRA requires the registering of specific clinical trials and the JRMO encourages registration of research studies on the Clinical Trials Register. To access the Clinical Trials Register please contact research.governance@qmul.ac.uk
Obtaining an International Standard Randomised Controlled Trial Number (ISRCTN)
Obtaining this number means that your trial is registered on an international database of randomised control trials (RCTs). The ISRCTN Register accepts the registration of RCTs and any other research study designed to assess the efficacy of health interventions in a human population, including observational and interventional studies. Clinical trials should register to obtain an ISRCTN number as some journals require evidence of this number prior to publishing a paper
The study is definitely a CTIMP/ATIMP: is there anything additional I need to do?
CTIMP/ATIMP studies should be discussed with the GCP Team as soon as possible and preferably before any funding applications are submitted.
In addition, you will need to work with the sponsor (see SOP 42a) and apply to the MHRA which is can be found on the IRAS website (see SOP 11a).
Setting up a study with a medical product means you need to have resources to cover some additional aspects, including:
