01022

Study Phase Identifier

2003-08-22
Definition: This field identifies the phase of the study that a patient has entered. The set of codes will generally be developed for each clinical trial, although there are patterns that trials in particular disease or prevention categories may follow. The phase structure will be based on data collation and reporting needs for the study. It is an operational structure and need not be discussed in the clinical trial protocol documentation or even made known to patient care or data collection personnel. The coding system will usually be developed by the sponsor for multicentered clinical trials to standardize the receipt of automated data. Local codes could be added if an additional local message is desired. Otherwise, local coding conventions will be used. Example: 2^Init Rx, Crs 1^NCI T93-0807 Phases
Length≤250
6 components
1O-Identifier
2O-Text
3OName of Coding System
4O-Alternate Identifier
5O-Alternate Text
6OName of Alternate Coding System