Table 1 Suggested content of the data pack ready for sharing
Suggested content of data pack | Description |
|---|---|
Anonymised data | Electronic data collected for each patient in the trial in a format that can be recognised by a wide range of statistical software (e.g. SAS, Stata, R). The use of “StatTransfer” or other similar product may be useful for this purpose |
Blank CRF | Blank CRFs with descriptions of the data collected. These could be annotated to provide a map of the data variables within the dataset, or provided as blank CRFs along with dataset specifications |
Dataset specifications | Meta-data describing the datasets e.g. data-freeze date, variable labels, variable descriptions, formats, anonymisation method applied to each variable and summary of amendments made during the trial e.g. changing data definitions, adding/removing variables |
Protocol | Trial protocol, including all amendments |
Statistical analysis plan | Methods of analysis and procedures for data handling used in the final statistical analysis (this is useful if researchers want to replicate published analyses to facilitate their understanding of the dataset) |
Analysis programs | Programmes used for generating and analysing data used in the final analysis report (this is useful if researchers want to replicate published analyses to facilitate their understanding of the dataset) |
Clinical study report (CSR) (or equivalent) if applicable | Report of efficacy and safety data from the trial that forms the basis of submissions to regulatory authorities e.g. EMA |