CDASH RYZE Example.Routine Laboratory Testing

This is an example CRF used to collect routine safety labortory tests from local laboratories in tobacco studies. The lab names may be collected only when multiple labs are used by a site. The lab test name are often pre-printed on the CRF. The names are not included as they are study specific. In order to save space, some of the permissible values are only shown in the metadata specifications.

Section 1

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values
1	What was the name of the laboratory used?	Laboratory Name	Record the laboratory name	Text	LBNAM	LBNAM
2	Was the lab performed?	Lab Performed	Indicate whether or not lab specimen was collected, or measurement performed.	Text	LBPERF	LBSTAT	LBSTAT = "NOT DONE" where LBPERF = "N" and LBSTAT = null where LBPERF = "Y"	(NY)	Yes; No
3	What was the date of the lab specimen collection?	Specimen Collection Date	Record the date of specimen collection .	Date	LBDAT	LBDTC
4	What was the time of the lab specimen collection?	Specimen Collection Time	Record time of collection (as complete as possible).	Time	LBTIM	LBDTC
5	Was the subject fasting?	Fasting	Record whether the subject was fasting prior to the test being performed	Text	LBFAST	LBFAST

Section 2

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values
6	What is the lab test name?	Lab Test Name	Record the name of the lab measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.	Text	LBTEST	LBTEST; LBTESTCD	LBTEST and LBTESTCD	(LBTEST)	WBC; RBC, cells,Protein Urinalysis; Cholesterol, Albumin, Creatinine
7	What was the result of the lab test?	Result	Record laboratory test result.	Text	LBORRES	LBORRES
8	What was the unit of the lab result?	Unit	Record or select the original unit in which these data were collected, if not pre-printed on CRF.	Text	LBORRESU	LBORRESU		(UNIT)	g/L; mg/dL; mg/L; U/mL; ug/L; sec; RATIO
9	What was the lower limit of the reference range for this lab test?	Normal Range Lower Limit	Record the lower limit of the reference range of the lab test.	Text	LBORNRLO	LBORNRLO
10	What was the high limit of the reference range for this lab test?	Normal Range Upper Limit	Record the upper limit of the reference range of the lab test.	Text	LBORNRHI	LBORNRHI
11	Was this result clinically significant?	Clinically Significant	Record whether lab results were clinically significant.	Text	LBCLSIG	LBCLSIG		(NY)	Yes; No

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CDASH RYZE Example.Routine Laboratory Testing