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Name and affiliation of the lead researcher
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Statement of the Scientific Goals of the Research
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Synopsis of Research Proposal
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Lay version may also be needed
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Statistical Analysis Plan (SAP)
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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
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Studies for which data is requested
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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)
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Include all studies to be combined including those obtained from other sources (e.g. studies completed by your own institution)
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Name and affiliation of other members of the research team
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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.
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Some Data Holders require CVs or other information as reference.
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Conflicts of interest
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Both real and potential
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Source of Funding
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This is the funding source for the researcher.
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Currently Data Holders do not require payment for the preparation and access to the patient level datasets.
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