EFSPI/PSI working group on data sharing: accessing and working with pharmaceutical clinical trial patient level datasets – a primer for academic researchers

Table 3 Key components of a research request form

Proposal component	Additional notes
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)
Studies for which data is requested	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.
Name and affiliation of other members of the research team	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.
Source of Funding	Currently Data Holders do not require payment for the preparation and access to the patient level datasets.