| 2 | Identify collection domains and fields. | Review collection standards in this guide to determine which of the identify data collection domains and fields are already specified in the published domainswhich align with collection requirements. As much as possible, the standard domains should domains in this guide will be used to collect data in a manner that will be effective for data collection. Develop the Develop the data collection tools using these published, standard domains first. Prior to creating a custom domain, confirm that none of the existing published domains will fit the need. Once confirmed, drafting a specification upfront, using conventions domains in this guide first. Create additional fields in alignment with guidance in Section x.x, How to Read Domain Specifications, is recommended to ensure expectations for the custom domain are clear. Determine which domains and fields are already specified in the published domainsReview the domains published in the CDASHIG to . As much as possible, the standard domains should be used to collect data in a manner that will be effective for data collection. Develop the data collection tools using these published, standard domains first.
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| During the development of CDASH-conformant collection instruments (e.g., CRFs, eCOA screens), the SDTMIG domain to which the collected data is to be mapped must be determined. The choice of the SDTMIG domain to use does not depend upon the mode of transmission, the methodology used to generate the data, the medium used to store the data, the person who recorded the data, or the subject described by the data. The SDTMIG domain to be used affects what CDASH variable names, question texts, prompts, controlled terminology, and so on, to use. CDASH suggests a format to be presented to those entering the data, but it does not dictate any data structure in which to store the collected data (often referred to as a data management operational database). |