01022

Study Phase Identifier

2015-07-13
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
LengthNot specified
22 components
1O-Identifier
2O-Text
3CName of Coding System
4O-Alternate Identifier
5O-Alternate Text
6CName of Alternate Coding System
7C-Coding System Version ID
8O-Alternate Coding System Version ID
9O-Original Text
10O-Second Alternate Identifier
11O-Second Alternate Text
12CName of Second Alternate Coding System
13O-Second Alternate Coding System Version ID
14C-Coding System OID
15O-Value Set OID
16C-Value Set Version ID
17C-Alternate Coding System OID
18O-Alternate Value Set OID
19C-Alternate Value Set Version ID
20C-Second Alternate Coding System OID
21O-Second Alternate Value Set OID
22C-Second Alternate Value Set Version ID

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