| 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 conformant collection instruments, the tabulation domain to which the collected data is to be mapped will be determined. A tabulation domain will be used when the nature of the data aligns with the scope of a domain and irrespective of the mode of data 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.
Example 1: A study has meal-consumption diary data captured via a subject-completed PRO. Another study also captures meal-consumption data, but the subject takes a photo of the food prior to and after the meal, and sends the photos to a third party, which determines food consumption. Even though captured in different ways, the data from both studies will map into the SDTMIG Meal Data (ML) domain. Example 2: A study has subjects' blood samples sent to a central lab, which analyzes the samples and sends results to the sponsor via electronic data transfer. In a second study, the samples are analyzed locally and results are captured on a CRF. The laboratory results from both studies are stored in the SDTMIG Laboratory Test Results (LB) domain. CDASH recommends that dates be collected in an unambiguous format and suggests using the DD-MON-YYYY format. This defines the format to be presented to those entering the data, but does not define the electronic format in which to store the data. One system may store each date as a character field; another may store them as numeric values (e.g., an SAS date); and yet another as 3 separate fields formatted as day, month, and year. Each of these is a legitimate way to store the data collected.
During the development of conformant CRFs the tabulation domain to which the collected data will be mapped must be determined. The choice of the 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). |