DATA ELEMENTS BEING REQUESTED
Provide the range of data being requested from the identified dataset. Address required patient set, time-point, data fields such as demographics and results, and whether the request is for a redacted full CSRs or an IPD. Be as specific as possible.)
Provide synopsis of the methods and analysis plan including the analytical methods to be used to test the hypothesis. Details about any exploratory analyses to support the hypothesis or to describe the patient sample or data set.)
Provide how this research has scientific merit. Tie-in to how it strengthens the understanding of the study or advances the field of study.
RESOURCES/COLLABORATION REQUIRED FROM SPONSOR OR STUDY LEADERSHIP
Identify expected need for assistance from BSC or study personnel beyond delivery of requested dataset. Considerations may include explanation of procedure details beyond the protocol, understanding of past analysis, product details. Note that need for BSC collaboration may impact timeliness of data delivery.)
Provide preliminary plans for presentation and publication of results.