Table 3 Key components of a research request form

Name and affiliation of the lead researcher

Statement of the Scientific Goals of the Research

Synopsis of Research Proposal

Lay version may also be needed

Statistical Analysis Plan (SAP)

Including endpoints to be evaluated, analytic methods to used and methods to control for bias in post-hoc or data driven analyses. Should also state whether specific populations are to be analysed e.g. effects of treatment in special patient groups

Studies for which data is requested

Use unique study ID if known and database version required (if the study has been conducted over a long period of time and has been analysed at different follow-up time points)

Include all studies to be combined including those obtained from other sources (e.g. studies completed by your own institution)

Name and affiliation of other members of the research team

There should be a professionally qualified statistician or confirmation that the proposed research team has the relevant statistical expertise to perform and take responsibility for all statistical analyses should be provided.

Some Data Holders require CVs or other information as reference.

Conflicts of interest

Both real and potential

Source of Funding

This is the funding source for the researcher.

Currently Data Holders do not require payment for the preparation and access to the patient level datasets.