Background Heart Failure Maintenance Medications aCRF

Illustrates Domains

Illustrates Variables

CMREASOC
CMINDC
CMTRT
CMONGO
CMRRGYN
CMRRGREA

Content

This is an example of a CRF used to collect data on the types of background maintenance medications for heart failure used during the study. The specific types of medications and the reasons for not prescribing a medication are study-specific.

Part 1 of the CRF collects information on selected heart failure medication classes and the reasons they were not taken, as well as information on the specific medication taken. The details for the specific heart failure maintenance medications used were then collected on part 2 of the CRF. (As previously noted, sponsors can customize medication classes and reasons, as needed.)

CRF Instructions

Part 1: Indicate whether the listed class/type of background heart failure medication was prescribed to the subject (see the study protocol for details).

Part 2: List the specific background heart failure medications used. Include all heart failure medications that are to be continued. When a subject has frequent changes in the dose and schedule for oral diuretics, the dosing information can be recorded as PRN.

Part 1

	CMCAT Hidden/pre-populated	Heart Failure Maintenance Medication
	Concomitant Medications Pre-Specified CMPRESP Hidden/pre-populated	Y <From NY codelist>
Indicate if any ACE inhibitors were taken. If Yes, include the appropriate information in Background Heart Failure Maintenance Medications - Part 2.	Were any angiotensin-converting enzyme (ACE) inhibitors taken? ACEHF_CMOCCUR CMOCCUR where CMTRT="ACE Inhibitors"	Yes No <From NY codelist>
Indicate the reason ACE inhibitors were not prescribed. If the reason is unknown, select "Unknown."	If No, provide reason for not prescribing ACE inhibitors. ACEHF_CMREASOC NSCM.CMREASOC where CMTRT="ACE Inhibitors"	Contraindication Treatment not indicated Cost Unknown
Indicate if any beta blockers were taken. If Yes, include the appropriate information in Part 2.	Were any beta blockers taken? BBHF_CMOCCUR CMOCCUR where CMTRT="Beta Blockers"	Yes No <From NY codelist>
Indicate the reason beta blockers were not prescribed. If the reason is unknown, select "Unknown."	If No, provide reason for not prescribing beta blockers. BBHF__CMREASOC NSCM.CMREASOC where CMTRT="Beta Blockers"	Contraindication Treatment not indicated Cost Unknown
Indicate if any ARBs were taken. If Yes, include the appropriate information in Part 2.	Were any angiotensin receptor blockers (ARBs) taken? ARBHF_CMOCCUR CMOCCUR where CMTRT="ARBs"	Yes No <From NY codelist>
Indicate the reason ARBs were not prescribed. If the reason is unknown, select "Unknown."	If No, provide reason for not prescribing ARBs. ARBHF__CMREASOC NSCM.CMREASOC where CMTRT= "ARBs"	Contraindication Treatment not indicated Cost Unknown
Indicate if any ARNIs were taken. If Yes, include the appropriate information in Part 2.	Were any angiotensin receptor/neprilysin inhibitors (ARNIs) taken? ARNI_CMOCCUR CMOCCUR where CMTRT="ARNIs"	Yes No <From NY codelist>
Indicate the reason ARNIs were not prescribed. If the reason is unknown, select "Unknown."	If No, provide reason for not prescribing ARNIs. ARNI_CMREASOC NSCM.CMREASOC where CMTRT="ARNIs"	Contraindication Treatment not indicated Cost Unknown Cost Unknown
Indicate if any aldosterone antagonists were taken. If Yes, include the appropriate information in Part 2.	Were any aldosterone antagonists taken? ALDO_CMOCCUR CMOCCUR where CMTRT="Aldosterone Antagonists"	Yes No <From NY codelist>
Indicate the reason aldosterone antagonists were not prescribed. If the reason is unknown, select "Unknown."	If No, provide reason for not prescribing aldosterone antagonists. ALDO_CMREASOC NSCM.CMREASOC where CMTRT="Aldosterone Antagonists"	Contraindication Treatment not indicated Cost Unknown
Indicate if any hydralazine was taken. If Yes, include the appropriate information in Part 2.	Was any hydralazine taken? HYDISO__CMOCCUR CMOCCUR where CMTRT="Hydralazine"	Yes No <From NY codelist>
Indicate the reason hydralazine was not prescribed. If the reason is unknown, select "Unknown."	If No, provide reason for not prescribing hydralazine. HYDISO_CMREASOC NSCM.CMREASOC where CMTRT="Hydralazine"	Contraindication Treatment not indicated Cost Unknown
Indicate if any diuretics were taken. If Yes, include the appropriate information in Part 2.	Were any diuretics taken? DIURETICS_CMOCCUR CMOCCUR where CMTRT="Diuretics"	Yes No <From NY codelist>
Indicate the reason diuretics were not prescribed. If the reason is unknown, select "Unknown."	If No, provide reason for not prescribing diuretics. DIURETICS_CMREASOC NSCM.CMREASOC where CMTRT="Diuretics"	Contraindication Treatment not indicated Cost Unknown

View CRF Metadata

Order Number	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Variable	SDTM Target Variable Mapping	Controlled Terminology Code List Name	CRF Implementation notes	Permissible Values	Pre-specified Value	List Style	Hidden
1	CMCAT	N/A	N/A	N/A	text	CMCAT					Heart Failure Maintenance Medication		Y
2	CMPRESP	N/A	Concomitant Medications Pre-Specified		text	CMPRESP		(NY)			Y		Y
3	ACEHF_CMOCCUR	Were any angiotensin-converting enzyme (ACE) inhibitors taken?	Any ACE Inhibitor(s) Taken	Indicate if any ACE inhibitors were taken. If Yes, include the appropriate information in Background Heart Failure Maintenance Medications - Part 2.	text	CMOCCUR	CMOCCUR where CMTRT="ACE Inhibitors"	(NY)	This question is used for EDC navigation to the appropriate form.	Yes;No		Radio
4	ACEHF_CMREASOC	If No, provide reason for not prescribing ACE inhibitors.	Reason no ACE Inhibitors Prescribed	Indicate the reason ACE inhibitors were not prescribed. If the reason is unknown, select "Unknown."	text	NSCM.CMREASOC	NSCM.CMREASOC where CMTRT="ACE Inhibitors"		The prespecified responses are only examples; other responses may be used.	Contraindication;Treatment not indicated;Cost;Unknown		Radio
5	BBHF_CMOCCUR	Were any beta blockers taken?	Any Beta Blockers Taken	Indicate if any beta blockers were taken. If Yes, include the appropriate information in Part 2.	text	CMOCCUR	CMOCCUR where CMTRT="Beta Blockers"	(NY)	If Yes, Concomitant Medication form should be completed.	Yes;No		Radio
6	BBHF__CMREASOC	If No, provide reason for not prescribing beta blockers.	Reason no Beta Blockers Prescribed	Indicate the reason beta blockers were not prescribed. If the reason is unknown, select "Unknown."	text	NSCM.CMREASOC	NSCM.CMREASOC where CMTRT="Beta Blockers"		If No, the reason should be recorded.	Contraindication;Treatment not indicated;Cost;Unknown		Radio
7	ARBHF_CMOCCUR	Were any angiotensin receptor blockers (ARBs) taken?	Any ARBs Taken	Indicate if any ARBs were taken. If Yes, include the appropriate information in Part 2.	text	CMOCCUR	CMOCCUR where CMTRT="ARBs"	(NY)	If Yes, Concomitant Medication form should be completed.	Yes;No		Radio
8	ARBHF__CMREASOC	If No, provide reason for not prescribing ARBs.	Reason no ARBs Prescribed	Indicate the reason ARBs were not prescribed. If the reason is unknown, select "Unknown."	text	NSCM.CMREASOC	NSCM.CMREASOC where CMTRT= "ARBs"		If No, the reason should be recorded.	Contraindication;Treatment not indicated;Cost;Unknown		Radio
9	ARNI_CMOCCUR	Were any angiotensin receptor/neprilysin inhibitors (ARNIs) taken?	Any ARNIs Taken	Indicate if any ARNIs were taken. If Yes, include the appropriate information in Part 2.	text	CMOCCUR	CMOCCUR where CMTRT="ARNIs"	(NY)	If Yes, Concomitant Medication form should be completed.	Yes;No		Radio
10	ARNI_CMREASOC	If No, provide reason for not prescribing ARNIs.	Reason no ARNIs Prescribed	Indicate the reason ARNIs were not prescribed. If the reason is unknown, select "Unknown."	text	NSCM.CMREASOC	NSCM.CMREASOC where CMTRT="ARNIs"		If No, the reason should be recorded.	Contraindication;Treatment not indicated;Cost;Unknown;Cost;Unknown		Radio
11	ALDO_CMOCCUR	Were any aldosterone antagonists taken?	Any Aldosterone Antagonists Taken	Indicate if any aldosterone antagonists were taken. If Yes, include the appropriate information in Part 2.	text	CMOCCUR	CMOCCUR where CMTRT="Aldosterone Antagonists"	(NY)	If Yes, Concomitant Medication form should be completed.	Yes;No		Radio
12	ALDO_CMREASOC	If No, provide reason for not prescribing aldosterone antagonists.	Reason no Aldosterone Antagonist Prescribed	Indicate the reason aldosterone antagonists were not prescribed. If the reason is unknown, select "Unknown."	text	NSCM.CMREASOC	NSCM.CMREASOC where CMTRT="Aldosterone Antagonists"		If No, the reason should be recorded.	Contraindication;Treatment not indicated;Cost;Unknown		Radio
13	HYDISO__CMOCCUR	Was any hydralazine taken?	Any Hydralazine Taken	Indicate if any hydralazine was taken. If Yes, include the appropriate information in Part 2.	text	CMOCCUR	CMOCCUR where CMTRT="Hydralazine"	(NY)	If Yes, Concomitant Medication form should be completed.	Yes;No		Radio
14	HYDISO_CMREASOC	If No, provide reason for not prescribing hydralazine.	Reason no Hydralazine prescribed	Indicate the reason hydralazine was not prescribed. If the reason is unknown, select "Unknown."	text	NSCM.CMREASOC	NSCM.CMREASOC where CMTRT="Hydralazine"		If No, the reason should be recorded.	Contraindication;Treatment not indicated;Cost;Unknown		Radio
15	DIURETICS_CMOCCUR	Were any diuretics taken?	Any Diuretics Taken	Indicate if any diuretics were taken. If Yes, include the appropriate information in Part 2.	text	CMOCCUR	CMOCCUR where CMTRT="Diuretics"	(NY)	If Yes, Concomitant Medication form should be completed.	Yes;No		Radio
16	DIURETICS_CMREASOC	If No, provide reason for not prescribing diuretics.	Reason no Diuretics Prescribed	Indicate the reason diuretics were not prescribed. If the reason is unknown, select "Unknown."	text	NSCM.CMREASOC	NSCM.CMREASOC where CMTRT="Diuretics"		If No, the reason should be recorded.	Contraindication;Treatment not indicated;Cost;Unknown		Radio

Part 2

	CMCAT Hidden/pre-populated	Heart Failure Maintenance Medication
	CMINDC Hidden/pre-populated	Chronic Heart Failure
Record only 1 medication per line. Provide the full trade or proprietary name of the medication; otherwise, the generic name may be recorded.	What was the medication name? CMTRT	_________________
Record the dose of concomitant medication taken per administration (e.g., 200).	What was the individual dose of the medication per administration? CMDOSE	_________________
Record the dose unit of the dose of concomitant medication taken (e.g., mg).	What is the unit of the medication per administration? CMDOSU	_________________ <From UNIT codelist>
Record how often the concomitant medication was taken (e.g., BID, PRN).	What was the frequency of the medication? CMDOSFRQ	_________________ <From FREQ codelist>
Provide the route of administration for the concomitant medication.	What was the route of administration of the medication? CMROUTE	_________________ <From ROUTE codelist>
Record the date the concomitant medication was first taken, using this format (DD-MON-YYYY).	Start Date CMSTDAT CMSTDTC	_ _ / _ _ _ / _ _ _ _
Record the concomitant medication as ongoing or not, to indicate whether the subject has stopped taking the concomitant medication at the time of data collection. If the concomitant medication is ongoing, leave the end date blank.	Is the medication ongoing? CMONGO CMENRF or CMENRTPT	_________________ <From NY codelist>
Record the date the concomitant medication was stopped, using this format (DD-MON-YYYY). If the subject has not stopped taking the concomitant medication, leave this field blank.	End Date CMENDAT CMENDTC	_ _ / _ _ _ / _ _ _ _
Indicate if, in the investigator's opinion, the dose regimen was given at the recommended regimen, according to the heart failure standard-of-care guidelines referenced in the protocol.	If applicable, was the medication given at the recommended regimen? CMRRGYN NSCM.CMRRGYN	_________________ <From NY codelist>
Provide the reason why the recommended dose regimen was not administered at the recommended regimen.	If applicable, why was the medication not given at the recommended regimen? CMRRGREA NSCM.CMRRGREA	_________________

View CRF Metadata

Order	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target	SDTM Variable Mapping	Controlled Terminology Code List Name	Pre-specified Value	Hidden
1	CMCAT	N/A	N/A		text	CMCAT			Heart Failure Maintenance Medication	Y
2	CMINDC	N/A	N/A		text	CMINDC			Chronic Heart Failure	Y
3	CMTRT	What was the medication name?	Concomitant Medication	Record only 1 medication per line. Provide the full trade or proprietary name of the medication; otherwise, the generic name may be recorded.	Text	CMTRT
4	CMDOSE	What was the individual dose of the medication per administration?	Dose	Record the dose of concomitant medication taken per administration (e.g., 200).	Text	CMDOSE
5	CMDOSU	What is the unit of the medication per administration?	Units	Record the dose unit of the dose of concomitant medication taken (e.g., mg).	Text	CMDOSU		(UNIT)
6	CMDOSFRQ	What was the frequency of the medication?	Frequency	Record how often the concomitant medication was taken (e.g., BID, PRN).	Text	CMDOSFRQ		(FREQ)
7	CMROUTE	What was the route of administration of the medication?	Route	Provide the route of administration for the concomitant medication.	Text	CMROUTE		(ROUTE)
8	CMSTDAT	What was the medication start date?	Start Date	Record the date the concomitant medication was first taken, using this format (DD-MON-YYYY).	Date	CMSTDTC
9	CMONGO	Is the medication ongoing?	Ongoing	Record the concomitant medication as ongoing or not, to indicate whether the subject has stopped taking the concomitant medication at the time of data collection. If the concomitant medication is ongoing, leave the end date blank.	Text	CMENRF; CMENRTPT	CMENRF or CMENRTPT	(NY)
10	CMENDAT	What was the medication end date?	End Date	Record the date the concomitant medication was stopped, using this format (DD-MON-YYYY). If the subject has not stopped taking the concomitant medication, leave this field blank.	Date	CMENDTC
11	CMRRGYN	If applicable, was the medication given at the recommended regimen?	Taken at Recommended Regimen	Indicate if, in the investigator's opinion, the dose regimen was given at the recommended regimen, according to the heart failure standard-of-care guidelines referenced in the protocol.	Text	NSCM.CMRRGYN		(NY)
12	CMRRGREA	If applicable, why was the medication not given at the recommended regimen?	Reason Not Taken at Recommended Regimen	Provide the reason why the recommended dose regimen was not administered at the recommended regimen.	Text	NSCM.CMRRGREA