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.
MHYN
N/A
(NY)
Yes; No
2
Medical History Category
MHCAT
MHCAT
GENERAL MEDICAL HISTORY
3
What is the medical condition or event identifier?
MH Number
Applicant-Defined CRF Completion Instructions
MHSPID
MHSPID
4
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.
MHTERM
MHTERM
5
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).
MHSTDAT
MHSTDTC
6
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.
MHONGO
MHENRF/ MHENRTPT
(NY)
Yes; No
7
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).