CDASH RYZE Example.Medical History

This is an example Medical History CRF. This CRF collects verbatim descriptions of any medical conditions or events experienced by the subject. This CRF was designed to allow the applicant to use either MHENRF or MHENRTPT to represent an event was ongoing

Section 1

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
1	Has the subject had any medical conditions or events?	Any Medical History	Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.	Text	MHYN	N/A	Not Submitted	(NY)	Yes; No

Section 2

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values
2	Has the subject had any medical conditions or events?	Any Medical History	Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.	Text	MHYN	N/A	Not Submitted	(NY)	Yes; No
3		Medical History Category		Text	MHCAT	MHCAT			GENERAL MEDICAL HISTORY
4	What is the medical condition or event identifier?	MH Number	Applicant-Defined CRF Completion Instructions	Text	MHSPID	MHSPID
5	What is the medical condition or event term?	Medical History Term	Record all relevant medical conditions or events, as defined in the protocol. Record only one medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria.	Text	MHTERM	MHTERM
6	What was the medical condition or event start date?	Start Date	Record the start date of the medical event or condition using this format (DD-MON-YYYY).	Date	MHSTDAT	MHSTDTC
7	Is the medical condition or event ongoing?	Ongoing	Record the medical condition or event as ongoing (Yes) if it has not ended at the time of data collection; the end date should be left blank.	Text	MHONGO	MHENRF/ MHENRTPT		(NY)	Yes; No
8	What was the medical condition or event end date?	End Date	Record the end date of the medical event or condition using this format (DD-MON-YYYY).	Date	MHENDTC	MHENDAT

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CDASH RYZE Example.Medical History