Prior to Building A Study

Sites may want to consider creating two documents in order to assist with the study build efforts; a study design specification and a study review document.

Foundry Health can provide additional guidance on what should be reviewed and what types of findings/topics might be worth documenting. This can be covered during customer onboarding phases, or, requested via service desk ticket.

Study Design Specification

This document should contain every unique form and contain the data field(s) to be collected upon during the trial. Typically this would include the form and item names as well as prompts, data types, barcode requirements, ranges, units, SAS variables, ect. Additionally, a schedule of events may also be included in this document for assembling the study activity plans.

Study Review Document

This document could be used to track findings within the form design and activity plan review and clearly indicate to the study designer what the finding is and what the expected update should look like.