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Table 1 Examples of the objectives of research using CSR data

From: European Medicines Agency Policy 0070: an exploratory review of data utility in clinical study reports for academic research

Objective CSR section(s) that may be required Examples
Assessment of reporting and evaluation of bias Methods, results (aggregate summary tables and text), narratives, participant listings Eyding et al [4], Schroll et al [9], Hodkinson et al [10], Jefferson et al [11], Vedula et al [15]
Comparison of methods and/or results (including adverse events) with data registries or manuscripts Methods, results (aggregate summary tables and text) Eyding et al [4], Le Noury et al [8], Schroll et al [9], Hodkinson et al [10], Jefferson et al [11], Maund et al [12,13,14], Vedula et al [15], Nevitt et al [16]
Detailed evaluation of harms and adverse events Results (aggregate summary tables and text), narratives, participant listings Eyding et al [4], Maund et al [12,13,14]
Systematic review and meta-analysis (evidence synthesis) Methods, results (aggregate summary tables and text), narratives Eyding et al [4], Jefferson et al [11],
Maund et al [14], Nevitt et al [16]
Re-analysis (repeating original analysis) Methods, results (aggregate summary tables and text), narratives, participant listings Le Noury et al [8] (also using individual participant data)a
Re-analysis (different method or objective to the original analysis) Methods, results (aggregate summary tables and text), narratives, participant listings Maund et al [14], Nevitt et al [16]
  1. aIn this example, Le Noury et al [8], re-analysis was conducted using both individual participant data (IPD), requested via data sharing platform clinicalstudydatarequest.com [22] in addition to supporting information from CSRs and case report forms