Interested in accessing data from one of our trials?
Start by checking the information on the study page and protocol
If you are interested in exploring the possibility of accessing data from one of our trials, the first step is to check the information available on the study page and protocol, if available, to see if it is likely to meet your needs.
Does it meet your needs?
Check the data request requirements
Once you have checked the study page information, look at the application form and key questions that reviewers use to assess applications.
Completing the application form is an iterative process.
The form requires information about:
- Objectives and policy
- Study design
- Qualifications and suitability
- Data and samples required
- Ethical approval and consent requirements
- Planned outputs
- Authorship and publication
- Implications for the unit
- Funding and resources needed and support available
- A detailed protocol and statistical analysis plan are required along with other relevant documents e.g. grant applications, ethics approval.
There are several steps to an application
Applications go through the following stages:
- Discussion with Unit's principal investigator, usually before formal application, to scope the science, practicality and resource requirements. View Senior Staff profiles. To contact the relevant study team, please use the email address on the study page.
- Discussion of the detail of the intended proposal with the senior scientist at the Unit with overall responsibility for that research area.
- Review of the detail of the intended project by the Trial Management Group (or equivalent).
- Review by the Unit's Scientific Strategy Group, especially if there are resource implications for the Unit, e.g. it would involve Unit staff in undertaking new analyses or collecting additional data.
- Review by the Trial Steering Committee (or equivalent), which includes independent members, to assess the impact on the study.
- Review by the Independent Data Monitoring Committee, if intermediate or immature data are requested.
Download the application form
Key questions during review
Rationale, Merit, and Conduct of Project
- Scientific merit of the proposal
- Whether the trial data requested are suitable for answering the proposed research objectives
- Biases that might be present e.g. is the study population likely to be representative of the applicants' population of interest
- Whether the original researchers or previous applicants already have plans to use the data in the way proposed by the applicants i.e. prevent duplication
- Analyses are sufficiently well described to allow assessment that the methods in the proposal are fit for purpose
- Whether the applicants have sufficient resources to complete their study
- Motivation and suitability of the applicants, including whether the team (a) is suitably qualified to perform the analyses and (b) has the facility to handle the data.
Protection of Participants
- How would confidentiality be maintained?
- Does the original documented patient consent cover the proposal to release their data?
- Is approval by a Research Ethics Committee required?
Protection of the Integrity of the Original Trial
- Would the proposed use of data jeopardise the conduct or results of the trial from which the data are derived? If so, the proposal is unlikely to be supported at this time.
- Is there duplication? Have these data already been requested for this purpose?
- Are there implications for the future conduct or interpretation of the trial
- What resources would be required at the Unit to help investigators to understand the data, prepare the dataset, transfer the dataset, and perform the specified analyses.
- Are these resources available to or from the Unit?
- If not, could they be made available?
- What is the opportunity cost? (How much will the Unit's other work - e.g. ongoing trials - be affected when resources are diverted to fulfill this data request?)
- Are Unit staff considered providers of data or full collaborators?
- Are raw or summary data required?
- What version of the trial dataset is required?
- Do new data need to be collected? If so this will need approval by a Research Ethics Committee.