| 2 | Identify collection domains and fields. | Review collection standards in this guide to identify data collection domains and fields which align with collection requirements. As much as possible, domains in this guide will be used to collect data in a manner that will be effective for data collection. Develop the data collection tools using domains in this guide first. Create and use additional fields in alignment with guidance in Section x.x, How to Extend Metadata. |
| 3 | Identify the target tabulation domain. | During the development of CDASH- conformant collection instruments (e.g., CRFs , eCOA screens), the SDTMIG tabulation domain to which the collected data is to will be mapped must be determined. The choice of the SDTMIG domain will be based on 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). |