The following key steps are recommended to support development of CRFs using standards in this guide:
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| Order | Step | Implementation |
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| 1 | Identify data collection requirements. | Determine requirements for data collection from the protocol and by reviewing internally maintained libraries of standardized CRFs or from protocol data collection requirementswhen applicable. | | 2 | Identify collection domains and fields. | Determine which of the data collection 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. | | 3 |
| 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). |
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