The following steps are recommended to support development of CRFs using standards in this guide.
Order
Step
Implementation
1
Identify data collection requirements.
Determine requirements for data collection from the protocol and by reviewing internally maintained libraries of standardized CRFs when applicable.
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 2.7.2, How to Extend Metadata. Create new domains in alignment with Section 2.8.3,How to Create New Specifications.
3
Identify the target tabulation domain.
During the development of conformant collection instruments, the tabulation domain to which the collected data will 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.