SDTMIG Section 4.4.7, Relative Timing Variables needs to be linked to a Section in this TIG. This section seems to be missing.
In this example, a General Medical History CRF collected verbatim descriptions of any medical conditions or events experienced by the subject.
Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.
Has the subject had any medical conditions or events?
MHYNNot Submitted
<NY codelist>
Sponsor-Defined CRF Completion Instructions
MHSPID
_________________
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
_________________
Record the start date of the medical event or condition using this format (DD-MON-YYYY).
MHSTDATMHSTDTC
_ _ / _ _ _ / _ _ _ _
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.
Is the medical condition or event ongoing?
MHONGOMHENRF/ MHENRTPT
<NY codelist>
Record the end date of the medical event or condition using this format (DD-MON-YYYY).
MHENDATMHENDTC
_ _ / _ _ _ / _ _ _ _
CDASH Variable
Order
Question Text
Prompt
CRF Completion Instructions
Type
SDTMIG Target Variable
SDTMIG Target Mapping
Controlled Terminology Code List Name
Permissible Values
Pre-Populated Value
Query Display
List Style
Hidden
MHYN
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
N/A
(NY)
Yes; No
radio
MHSPID
3
What is the medical condition or event identifier?
MH Number
Sponsor-Defined CRF Completion Instructions
Text
MHSPID
MHTERM
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.
Text
MHTERM
MHSTDAT
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).
Date
MHSTDTC
prompt
MHONGO
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.
Text
MHENRF/ MHENRTPT
(NY)
Yes; No
radio
MHENDAT
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).
Date
MHENDTC
prompt
This is an example of an SDTM dataset used to represent the medical history collected on the above CRF. This CRF was designed to allow the sponsor to use either MHENRF or MHENRTPT to represent an event that was ongoing. This SDTM dataset used MHENRTPT. More information can be found in SDTMIG Section 4.4.7, Relative Timing Variables.
Rows 1-2:
The reported events were coded using a standard dictionary. MHDECOD and MHBODSYS display the preferred term and body system assigned through the coding process. MHENRTPT was populated based on the response to the "Ongoing" question on the General Medical History CRF. MHENTPT displays the reference date for MHENRTPT, that is, the date the information was collected. If "Yes" was specified for Ongoing, MHENRTPT = "ONGOING"; if "No" was checked, MHENRTPT = "BEFORE".
Row 3:
The start and end date of the reported event was displayed.