Pancreatic Cancer Study Treatment Infusion aCRF

Illustrates Domains

Illustrates Variables

ECPLDUSA
ECDOSRGM
ECINFIRP
ECADJYN
ECADJ
ECFRQADJYN
ECFRQADJ
ECINDADJYN
ECINDADJ
ECAENO1-ECAENOn

Content

This is an example of a CRF used to collect study drug administration; there are many ways that sponsors might design CRFs to collect exposure information. In this study, the sponsor collected information on the prescribed dose in mg/m2 and the actual dose administered in mg. Many sponsors have special procedures for reporting zero doses. If the study drug is permanently discontinued, a record with the dose indicated as zero is included.

CRF Instructions: Record each dose administered. If the study drug is permanently discontinued, enter a record with the dose indicated as zero.

Indicate whether this is the first dose.	Is this the first dose? FDOSEYN Not submitted	Yes No

View CRF Metadata

Order	Type	CDASHIG Variable	Question Text	Prompt	CRF Completion Instructions	SDTMIG Target	SDTMIG Target Mapping	Controlled Terminology Codelist Name	Permissible Values	Pre-populated Value	Query Display	List Style	Hidden
1	text	FDOSEYN	Is this the first dose?		Indicate whether this is the first dose.				Yes; No

Part 1: First Dose

Record the treatment .	What was the treatment? ECTRT	Treatment A Treatment B
	Route ECROUTE Hidden/pre-populated	INTRAVENOUS
	ECPLDUSA NSEC.ECPLDUSA where ECMOOD =" SCHEDULED" Hidden/pre-populated	PT90M
Record the intended dose regimen.	What was the intended dose regimen? ECDOSRGM ECDOSFRQ	EVERY 2 WEEKS EVERY 4 WEEKS OTHER
	If other, specify OTH_ECDOSRGM ECDOSFRQ	_________________
Record the prescribed dose using (mg/m2) based on BSA.	What was the prescribed dose in mg/m2 based on BSA? SCHED_ECDOSE ECDOSE where ECMOOD =" SCHEDULED"	_________________
	Units SCHED_ECDOSEU ECDOSEU where ECMOOD =" SCHEDULED" Pre-populated	mg/m2
Record the total dose administered in mg.	What was the actual total dose? PERF_ECDOSE ECDOSE where ECMOOD =" PERFORMED"	_________________
	Units PERF_ECDOSEU ECDOSEU where ECMOOD =" PERFORMED" Pre-populated	mg
	What was the date the infusion was started? ECSTDAT ECSTDTC	_________________
	What was the time the infusion was started? ECSTTIM ECSTDTC	_________________
	What was the date the infusion was ended? ECENDAT ECSTDTC	_________________
	What was the time the infusion was ended? ECENTIM ECSTDTC	_________________
	Was the infusion interrupted? ECINFIRP NSEC.ECINFIRP	Yes No

View CRF Metadata

Row	Type	CDASHIG Variable	Question Text	Prompt	CRF Completion Instructions	SDTMIG Target	SDTMIG Target Mapping	CRF Implementation Notes	Permissible Values	Pre-populated Value	Hidden
1	text	ECTRT	What was the treatment?	Treatment	Record the treatment .	ECTRT			Treatment A; Treatment B
2	text	ECROUTE	What was the route of administration?	Route	N/A	ECROUTE				INTRAVENOUS	Y
3	text	ECPLDUSA	N/A	N/A	N/A	NSEC.ECPDURSS	NSEC.ECPLDUSA where ECMOOD ="SCHEDULED"			PT90M	Y
4	text	ECDOSRGM	What was the intended dose regimen?	Intended Dose Regimen	Record the intended dose regimen.	ECDOSFRQ		The sponsor collected the planned frequency to track when the next dose was expected to be given. The reason for delays in administration were also collected. A sponsor may represent this by including ECMOOD="SCHEDULED".	EVERY 2 WEEKS; EVERY 4 WEEKS; OTHER
5	text	OTH_ECDOSRGM	If other, specify	Specify, If other		ECDOSFRQ
6	text	SCHED_ECDOSE	What was the prescribed dose in mg/m2 based on BSA?	Dose	Record the prescribed dose using (mg/m2) based on BSA.	ECDOSE	ECDOSE where ECMOOD ="SCHEDULED"	This CRF collects the intended dose in mg/m2 using ECDOSE. A sponsor may represent this by including ECMOOD="SCHEDULED"
7	text	SCHED_ECDOSEU	What were the dose units?	Units		ECDOSEU	ECDOSEU where ECMOOD ="SCHEDULED"			mg/m2
8	text	PERF_ECDOSE	What was the actual total dose?	Dose	Record the total dose administered in mg.	ECDOSE	ECDOSE where ECMOOD ="PERFORMED"	This CRF collects the total dose in mg using FAORRES. However, sponsors may collect this data using ECDOSE with the ECMOOD variable (e.g., ECMOOD="PERFORMED", as this represents the actual total dose administered).
9	text	PERF_ECDOSEU	What were the dose units?	Units		ECDOSEU	ECDOSEU where ECMOOD ="PERFORMED"			mg
10	text	ECSTDAT	What was the date the infusion was started?	Start Date		ECSTDTC
11	text	ECSTTIM	What was the time the infusion was started?	Start Time		ECSTDTC
12	text	ECENDAT	What was the date the infusion was ended?	End Date		ECSTDTC
13	text	ECENTIM	What was the time the infusion was ended?	End Time		ECSTDTC
14	text	ECINFIRP	Was the infusion interrupted?			NSEC.ECINFIRP			Yes; No

Part 2: Subsequent Dosing

	What was the treatment? ECTRT	Treatment A Treatment B
Record the prescribed duration of the infusion in minutes.	What was the prescribed duration of the infusion in minutes? ECPLDUSA NSEC.ECPLDUSA	_________________
Record the Intended dose regimen.	What was the intended dose regimen? ECDOSRGM ECDOSFRQ	EVERY 2 WEEKS EVERY 4 WEEKS
	Route ECROUTE Hidden/pre-populated	INTRAVENOUS
Record the prescribed dose using (mg/m2) based on BSA.	What was the prescribed dose in mg/m2 based on BSA? SCHED_ECDOSE ECDOSE where ECMOOD =" SCHEDULED"	_________________
	Units SCHED_ECDOSEU ECDOSEU where ECMOOD =" SCHEDULED" Pre-populated	mg/m2
Record the total dose administered in mg.	What was the actual total dose in mg? PERF_ECDOSE ECDOSE where ECMOOD =" PERFORMED"	_________________
	Units PERF_ECDOSEU ECDOSEU where ECMOOD =" PERFORMED" Pre-populated	mg
	What was the date the infusion was started? ECSTDAT ECSTDTC	_________________
	What was the time the infusion was started? ECSTTIM ECSTDTC	_________________
	What was the date the infusion was ended? ECENDAT ECSTDTC	_________________
	What was the time the infusion was ended? ECENTIM ECSTDTC	_________________
	Was the infusion interrupted? ECINFIRP NSEC.ECINFIRP	Yes No
	Was the dose adjusted from the previous administration? ECADJYN Not submitted	Yes No
	What was the reason the dose was adjusted from previous infusion? ECADJ	ADVERSE EVENT INVESTIGATOR DECISION NON-MEDICAL REASON OTHER
	Was the dose delayed? ECFRQADJYN Not submitted	Yes No
	What was the reason the dose was delayed? ECFRQADJ NSEC.ECFRQADJ	ADVERSE EVENT INVESTIGATOR DECISION NON-MEDICAL REASON OTHER
	Was the duration of the infusion adjusted from the previous administration? ECINDADJYN Not submitted	Yes No
	What was the reason the infusion duration was adjusted ECINDADJ NSEC.ECINDADJ	ADVERSE EVENT INVESTIGATOR DECISION NON-MEDICAL REASON OTHER
	What was the record number(s) of any adverse event that result in a dose or infusion duration change? ECAENO1-ECAENOn Associate with related AE record in RELREC	_________________

View CRF Metadata

Order	Type	CDASHIG Variable	Question Text	Prompt	CRF Completion Instructions	SDTMIG Target	SDTMIG Target Mapping	CRF Implementation Notes	Permissible Values	Pre-populated Value	Hidden
1	text	ECTRT	What was the treatment?	Treatment		ECTRT			Treatment A; Treatment B
2	text	ECPLDUSA	What was the prescribed duration of the infusion in minutes?	Duration	Record the prescribed duration of the infusion in minutes.	NSEC.ECPLDUSA		The sponsor converted the duration to the appropriate format.
3	text	ECDOSRGM	What was the intended dose regimen?	Intended Dose Regimen	Record the Intended dose regimen.	ECDOSFRQ			EVERY 2 WEEKS; EVERY 4 WEEKS
4	text	ECROUTE	What was the route of administration?	Route	N/A	ECROUTE				INTRAVENOUS	Y
5	text	SCHED_ECDOSE	What was the prescribed dose in mg/m2 based on BSA?	Dose	Record the prescribed dose using (mg/m2) based on BSA.	ECDOSE	ECDOSE where ECMOOD ="SCHEDULED"
6	text	SCHED_ECDOSEU	What were the dose units?	Units		ECDOSEU	ECDOSEU where ECMOOD ="SCHEDULED"			mg/m2
7	text	PERF_ECDOSE	What was the actual total dose in mg?	Dose	Record the total dose administered in mg.	ECDOSE	ECDOSE where ECMOOD ="PERFORMED"
8	text	PERF_ECDOSEU	What were the dose units?	Units		ECDOSEU	ECDOSEU where ECMOOD ="PERFORMED"			mg
9	text	ECSTDAT	What was the date the infusion was started?	Start Date		ECSTDTC
10	text	ECSTTIM	What was the time the infusion was started?	Start Time		ECSTDTC
11	text	ECENDAT	What was the date the infusion was ended?	End Date		ECSTDTC
12	text	ECENTIM	What was the time the infusion was ended?	End Time		ECSTDTC
13	text	ECINFIRP	Was the infusion interrupted?	Infusion Interrupted		NSEC.ECINFIRP			Yes;No
14	text	ECADJYN	Was the dose adjusted from the previous administration?	Dose Adjusted					Yes;No
15	text	ECADJ	What was the reason the dose was adjusted from previous infusion?	Reason Dose Adjusted		ECADJ			ADVERSE EVENT; INVESTIGATOR DECISION; NON-MEDICAL REASON; OTHER
16	text	ECFRQADJYN	Was the dose delayed?	Intervention Frequency Adjusted					Yes; No
17	text	ECFRQADJ	What was the reason the dose was delayed?	Intervention Frequency Adjustment Reason		NSEC.ECFRQADJ			ADVERSE EVENT; INVESTIGATOR DECISION; NON-MEDICAL REASON; OTHER
18	text	ECINDADJYN	Was the duration of the infusion adjusted from the previous administration?	Infusion Duration Adjustment					Yes; No
19	text	ECINDADJ	What was the reason the infusion duration was adjusted	Infusion Duration Adjustment Reason		NSEC.ECINDADJ			ADVERSE EVENT; INVESTIGATOR DECISION; NON-MEDICAL REASON; OTHER
20	text	ECAENO1-ECAENOn	What was the record number(s) of any adverse event that result in a dose or infusion duration change?				Associate with related AE record in RELREC