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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 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1Has the subject had any medical conditions or events?Any Medical HistoryIndicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.TextMHYNN/ANot Submitted(NY)N;Y

Section 2 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
2What is the category?Medical History Category
TextMHCATMHCAT

GENERAL MEDICAL HISTORY
3What is the medical condition or event identifier?MH NumberApplicant-Defined CRF Completion InstructionsTextMHSPIDMHSPID



4What is the medical condition or event term?Medical History TermRecord 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.TextMHTERMMHTERM



5What was the medical condition or event start date?Start DateRecord the start date of the medical event or condition using this format (DD-MON-YYYY).DateMHSTDATMHSTDTC



6Is the medical condition or event ongoing?OngoingRecord 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.TextMHONGOMHENRF/  MHENRTPTMHENRF or  MHENRTPT(NY)N:Y:
7What was the medical condition or event end date?End DateRecord the end date of the medical event or condition using this format (DD-MON-YYYY).DateMHENDTCMHENDAT



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