Insulin Exposure  

Illustrates Domains

CM
FA

Illustrates Variables

CMDOSFRQ
 FAORRES


Content

This CRF was used to record both (1) insulin therapy used before the start of the study and (2) insulin used as background therapy during the study. The CRF uses CMSTRF and CMENRF, but could have used CMSTRTPT and CMENRTPT. See CDASHIG v2.0 Section 3.7, Mapping Relative Times from Collection to Submissions, and SDTMIG v3.2 Section 4.1.4.7, Use of Relative Timing Variables, for more information (available at https://www.cdisc.org/standards).

Title: Insulin Management Prior to Study/Background Therapy

CRF Instructions

Enter a separate record for each type of insulin that was used. If the frequency of use was changed, enter each frequency as a separate record.


CMCAT Hidden/pre-populated
ANTIDIABETIC
CMSPID Hidden/pre-populated
Sponsor-defined
Record the specific type of insulin used by the subject, 1 type of insulin per line. Refer to the protocol for a list of insulins to be recorded.
CMTRT
_________________
Provide the route of administration for the medication. Route
CMROUTE

<From ROUTE codelist>

Record the usual frequency of injections or inhalations per day, or choose "Continuous" if subject was using an insulin pump. Frequency
CMDOSFRQ

<From FREQ codelist>

If available, record the date the insulin was first taken using this format (DD-MON-YYYY). If the subject has been taking insulin for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Prior concomitant medications that are exclusionary should have both a start date and an end date.
CMSTDAT CMSTDTC
_ _ / _ _ _ / _ _ _ _
If a start date is not available, indicate if the concomitant insulin was started before the study. Prior to Study
CMPRIOR CMSTRF

<From NY codelist>

Indicate if the insulin is ongoing (i.e., the subject has not stopped taking this type of insulin at the end of the study). The end date should be left blank. Is the medication ongoing?
CMONGO CMENRF

<From NY codelist>

If available, record the date insulin stopped using this format (DD-MON-YYYY). If the subject has not stopped taking insulin, leave this field blank.
CMENDAT CMENDTC
_ _ / _ _ _ / _ _ _ _
View CRF Metadata
OrderTAUG ReferenceCDASH VariableQuestion TextPromptCRF Completion InstructionsTypeSDTMIG TargetSDTM Variable MappingControlled Terminology Code List NameCRF Implementation NotesPermissible ValuesPre-specified ValueQuery DisplayList StyleHidden
1TAUG-T1D-P&DCMCATWhat is the category for the medication?Concomitant Medication CategoryRecord the medication category, if not printed on the CRF.TextCMCAT

The category is sponsor-defined.
ANTIDIABETIC

Y

2TAUG-T1D-P&DCMSPIDWhat is the medication identifier?CM Number
TextCMSPID

If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.
Sponsor-definedprompt
Y
3TAUG-T1D-P&DCMTRTWhat was the medication?Concomitant MedicationRecord the specific type of insulin used by the subject, 1 type of insulin per line. Refer to the protocol for a list of insulins to be recorded.textCMTRT







4TAUG-T1D-P&DCMROUTEWhat was the route of administration of the medication?RouteProvide the route of administration for the medication.TextCMROUTE

(ROUTE)


RESPIRATORY (INHALATION);SUBCUTANEOUS;


prompt

5TAUG-T1D-P&DCMDOSFRQWhat was the frequency of the medication?Frequency

Record the usual frequency of injections or inhalations per day, or choose "Continuous" if subject was using an insulin pump.

TextCMDOSFRQ
(FREQ)
PRN; QM; QOD; QD; BID; TID; QID; CONTINUOUS
promptradio
6TAUG-T1D-P&DCMSTDATWhat was the start date?Start Date

If available, record the date the insulin was first taken using this format (DD-MON-YYYY). If the subject has been taking insulin for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Prior concomitant medications that are exclusionary should have both a start date and an end date.

DateCMSTDTC




prompt

7TAUG-T1D-P&D

CMPRIOR

Was the insulin taken prior to prior to study start?Prior to StudyIf a start date is not available, indicate if the concomitant insulin was started before the study.TextCMSTRF

(NY)

Sponsors may collect this information rather than start dates. See CDASHIG v2.0 Section 3.7 and SDTMIG v3.2 Section 4.1.4.7 for more information.Yes
promptcheckbox
8TAUG-T1D-P&D

CMONGO

Is the medication ongoing?Ongoing

Indicate if the insulin is ongoing (i.e., the subject has not stopped taking this type of insulin at the end of the study). The end date should be left blank.

TextCMENRF
(NY)See CDASHIG v2.0 Section 3.7 and SDTMIG v3.2 Section 4.1.4.7 for more information.Yes

checkbox
9TAUG-T1D-P&DCMENDATWhat was the end date?End DateIf available, record the date insulin stopped using this format (DD-MON-YYYY). If the subject has not stopped taking insulin, leave this field blank.DateCMENDTC




prompt

This example CRF was used at each visit, including the baseline visit, to record the mean total daily dose of insulin over the previous 7 days for each type of insulin treatment that was ongoing.

Title: Insulin Management - Mean Total Daily Dose

VISDAT FADTC Hidden/pre-populated
Date of visit
Enter the medication identifier for the ongoing insulin treatment.
FACMNO FALNKID
_________________
If insulin is ongoing, record the mean total daily dose of insulin taken in the last 7 days.
DOSTOT_FAORRES FAORRES where FATESTCD = "DOSTOT" and FAOBJ = CMTRT and NSFA.FACOLSRT = "MEAN" and FAEVLINT = "-P7D"
. __.__
DOSTOT_FAORRESU FAORRESU where FATESTCD = "DOSTOT" and FAOBJ = CMTRT Hidden/pre-populated
U
View CRF Metadata
OrderTAUG ReferenceCDASH VariableQuestion TextPromptCRF Completion InstructionsTypeSDTMIG TargetSDTM Variable MappingControlled Terminology Code List NameCRF Implementation NotesPermissible ValuesPre-specified ValueQuery DisplayList StyleHidden
1TAUG-T1D-P&DVISDATWhat is the date of the visit?Visit Date
TextFADTC



Date of visit

Y
2TAUG-T1D-P&DFACMNOWhat is the identifier for the insulin treatment?Related Concomitant Medication IDEnter the medication identifier for the ongoing insulin treatment.TextFALNKID

This does not map directly to an SDTM variable. For the SDTM submission datasets, may be used to create RELREC to link this record with a record in the associated Prior/Concomitant Medications domain.




3TAUG-T1D-P&DDOSTOT_FAORRESWhat was the mean total daily dose over the last 7 days?Mean Total Daily DoseIf insulin is ongoing, record the mean total daily dose of insulin taken in the last 7 days.FloatFAORRESFAORRES where FATESTCD = "DOSTOT" and FAOBJ = CMTRT and NSFA.FACOLSRT = "MEAN" and FAEVLINT = "-P7D"






4TAUG-T1D-P&DDOSTOT_FAORRESUWhat was the unit?Unit
TextFAORRESUFAORRESU where FATESTCD = "DOSTOT" and FAOBJ = CMTRT


U

Y