The Biostatistics Design Workshop (BDW) is comprised of statisticians in the TCI-BSRF and provides a forum for statistical collaboration on the development, design, and analysis of investigator initiated cancer protocols (IITs). All investigators are encouraged to contact the biostatistician early in the development stage of their protocol, so they can get advice on study design, data management, and appropriate statistical methods for analyzing endpoints. The time for development of the statistical sections for a protocol ranges between 2‐4 weeks depending on the readiness of the protocol and the engagement of the PI. Typically it takes 2 weeks to gather the information needed for writing the statistical sections, and then 1‐2 weeks for editing. The statistician assigned to your protocol will present it to the BDW once they have completed the statistical sections of the protocol. You do not need to submit or present to the BDW. Please be advised that an automated notification from eRAP will be sent to the PI following the initial BDW review; this is for tracking purposes only. Statisticians will communicate progress to you and provide a final version of the protocol once it is approved.
Following are itemized steps of the BDW review process.