Start Date of Menstruation During a Study aCRF

Illustrates Domains

CE

Illustrates Variables

CEEVINTX
CETERM
CEOCCUR

Content

On-Study Start Date of Menstruation

CECAT Hidden/pre-populated
PUBERTAL STATUS
CESCAT Hidden/pre-populated
FEMALE
Indicate if the subject has started menstruation. If Yes, include the appropriate details where indicated on the CRF. Has the subject started menstruation since the last visit?
MENARCHE_CEOCCUR CEOCCUR

<From NY codelist>
MENARCHE_CEEVINTX CEEVINTX where CETERM="MENARCHE" Hidden/pre-populated
SINCE THE LAST VISIT
MENARCHE_CETERM CETERM Hidden/pre-populated
MENARCHE
If Yes, record the date of the first menstruation using this format (DD-MON-YYYY).
MENARCHE_CESTDTC CESTDTC
_________________
View CRF Metadata
Order  NumberTAUG ReferenceCDASHIG

  Variable 		CDASHIG Variable

  Label 		Question TextPromptData TypeCase Report Form

  Completion Instructions		SDTMIG TargetSDTMIG Variable

  Mapping		Controlled  Terminology Codelist NameCRF  Implementation NotesPermissible

  Values		Pre-specified

  Value		Query DisplayList StyleHiddenNotes/Questions
1TAUG-T1D-P&DCECATCategory for the Clinical EventWhat was the category for the clinical event?Category for the Clinical EventTextN/ACECATCECATN/ASponsor-defined Controlled Terminology

PUBERTAL STATUS



Y

2TAUG-T1D-P&DCESCATSubcategory for the Clinical EventWhat was the subcategory  for the clinical event?Subcategory for the Clinical EventTextN/ACESCATCESCATN/A



FEMALE



Y

3TAUG-T1D-P&DMENARCHE_CEOCCUR

Has the subject started menstruation since the last visit?





Any Reproductive System FindingsTextIndicate if the subject has started menstruation. If Yes, include the appropriate details where indicated on the CRF.CEOCCURCEOCCUR(NY)

No; Yes









4TAUG-T1D-P&DMENARCHE_CEEVINTXEvaluation Interval TextN/AEvaluation Interval TexttextN/ACEEVINTXCEEVINTX where CETERM="MENARCHE"N/A



SINCE THE LAST VISIT



Y

5TAUG-T1D-P&DMENARCHE_CETERMClinical Event Reported TermWhat is the clinical condition or event term?Clinical Event TermTextN/ACETERMCETERMN/A



MENARCHE



Y

6TAUG-T1D-P&DMENARCHE_CESTDTCReproductive System Findings  Test CodeWhat was the date of  first menstruation?

TextIf Yes, record the date of the first menstruation using this format (DD-MON-YYYY).CESTDTCCESTDTCN/A









Y