CDASH Product Accountability (DA)

Description

Product Accountability (DA) is a findings domain used to collect information about the dispensing and returning of investigational products used in a study.

Findings domains are typically represented in the vertical/normalized structure, which is usually the easiest and quickest way to collect, process, and clean data. However, users may have system constraints that prevent them from collecting data in the vertical/normalized manner. In such cases, the horizontal/denormalized version provides the structure necessary to collect the variables in another way.

Depending on the study design, the DA CRF/eCRF may not be required.

Care should be taken not to confuse product accountability with study product compliance or study product exposure. Comparing the amount dispensed to the subject and the amount returned by the subject does not necessarily mean the difference equates to the amount of treatment consumed by the subject or the subject's compliance with the study. For example, the subject could have misplaced some of the product and thus the return amount could provide a false estimate of compliance.

Because the actual product name may not be known to the site at the time of dispensing or returning, the word product in the context of the CDASHIG DA domain refers to the identifier that references the product (e.g., Product A, Product B,) rather than the actual (unblinded) product name.

The term dispensed refers to when the product is provided to the subject, not when the subject uses or consumes the studyproduct. The term returned refers to when the subject returns the unused study product to the investigational site.

Specification

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Observation Class	Domain	Data Collection Scenario	Implementation Options	Order Number	Collection Variable	Collection Variable Label	DRAFT Collection Definition	Question Text	Prompt	Data Type	Collection Core	Case Report Form Completion Instructions	Tabulation Target	Mapping Instructions	Controlled Terminology Codelist Name	Subset Controlled Terminology/CDASH Codelist Name	Implementation Notes
Findings	DA	N/A	Horizontal-Generic	1	STUDYID	Study Identifier	A unique identifier for a study.	What is the study identifier?	[Protocol/Study]	Char	HR	N/A	STUDYID	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.
Findings	DA	N/A	Horizontal-Generic	2	SITEID	Study Site Identifier	A unique identifier for a site within a study.	What is the site identifier?	Site (Identifier)	Char	HR	N/A	DM.SITEID	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-pre-printed on the CRFs that are shipped to each site. EDC: This should be pre-populated.
Findings	DA	N/A	Horizontal-Generic	3	SUBJID	Subject Identifier for the Study	A unique subject identifier within a site and a study.	What [is/was] the (study) [subject/participant] identifier?	[Subject/Participant] (Identifier)	Char	HR	Record the identifier for the subject.	DM.SUBJID	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated.This variable collection is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain.
Findings	DA	N/A	Horizontal-Generic	4	VISIT	Visit Name	The name of a clinical encounter that encompasses planned and unplanned study interventions, procedures, and assessments that may be performed on a subject.	What is the visit name?	[Visit]	Char	R/C	N/A	VISIT	Maps directly to the tabulation variable listed in the Tabulation Target column..	N/A	N/A	The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.
Findings	DA	N/A	Horizontal-Generic	5	VISDAT	Visit Date	Date the clinical encounter occurred (or started).	What [is/was] the date of the visit?	(Visit) Date	Char	R/C	Record the [date/start date] of the visit using this format (DD-MON-YYYY).	N/A	This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable DADTC in ISO 8601 format.	N/A	N/A	The date the accountability assessments were collected can be determined from the Visit Date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the DA CRF using the date (DADAT) field.
Findings	DA	N/A	Horizontal-Generic	6	DAGRPID	Product Accountability Group ID	An applicant-defined identifier used to tie a block of related records in a single domain.	What is the test group identifier?	Test Group Identifier	Char	O	Record unique group identifier. Applicant may insert additional instructions to ensure each record has a unique group identifier.	DAGRPID	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	It can be beneficial to use an identifier in a data query to communicate clearly to the site the specific record in question. This group identifier ties together all the tests collected on this horizontal record. This field may be populated by the applicant's data collection system.
Findings	DA	N/A	Horizontal-Generic	7	[DATESTCD]_DAPERF	Product Accountability Performed	An indication of whether a planned product accountability assessment was performed.	Was [DATEST] collected?	[DATEST] Collected	Char	O	Indicate whether or not product accountability was performed.	DASTAT	This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable DASTAT. If DAPERF="N", the value of DASTAT will be "NOT DONE". If DAPERF="Y", DASTAT should be null. A combination of tabulation variables ( e.g., DACAT and DASCAT, DATPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable DATESTCD would be populated as DAALL and an appropriate test name (DATEST) provided.	(NY)	N/A	This general prompt question is used as a data management tool to verify that missing results are confirmed missing. This may be implemented for all tests collected on the same horizontal record or for each specific test. When mapped to the tabulation dataset, the value of DAPERF would apply to all tests on the same record. Use the collection variable [DATESTCD]_DAPERF when implemented on a specific test basis. This is an example of the type of collection variable names that can be used in a denormalized data structure.
Findings	DA	N/A	Horizontal-Generic	8	[DATESTCD]_DACAT	DA Category of Assessment	A grouping of topic-variable values based on user-defined characteristics.	What was the type of product for which accountability was assessed?	Product Type	Char	O	Record the type of study product for which accountability is assessed.	DACAT	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Applicant-defined controlled terminology. If the protocol allows dispensing different types of study product the CRF can capture the type of product using DACAT. This may be pre-printed on the CRF. If DACAT is not collected (e.g., it is evident from the protocol design), it could be populated during the tabulation dataset creation process. The value of DACAT would apply to all measurements on that record when mapped to the tabulation dataset. If needed, the collection variable [DATESTCD]_DACAT may be used to collect a category for each DATEST.
Findings	DA	N/A	Horizontal-Generic	9	[DATESTCD]_DASCAT	DA Subcategory of Assessment	A sub-division of the DACAT values based on user-defined characteristics.	What was the name of the product for which accountability was assessed?	[DATEST] Product Name	Char	O	Record the name of the study product dispensed.	DASCAT	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Applicant-defined controlled terminology. This would most commonly be either a heading or a category value pre-printed on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a applicant-defined codelist. If the form is laid out as a grid, then words such as "Subcategory" can be included as the column header. If known at the time of data collection, the product name may be collected in DASCAT (with appropriate grouping values, but different from those for DACAT). The value of DASCAT would apply to all measurements on that record when mapped to the tabulation dataset. If needed, the collection variable [DATESTCD]_DASCAT may be used to collect a category for each DATEST.
Findings	DA	N/A	Horizontal-Generic	10	[DATESTCD]_DAREFID	Product Accountability Reference ID	An internal or external identifier such as product label identifier.	What is the [DATEST] product label identifier?	[DSTEST] Product Label Identifier	Char	O	Record dispensed product label identifier.	DAREFID	Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in EX domain.	N/A	N/A	The packaging identifier may be collected in different ways (e.g., affixing label onto CRF, scanning a bar code). For some cases, greater granularity for product identifiers may be needed. In this situation, applicants may need to use additional variables. This is an example of the type of collection variable names that can be used in a denormalized data structure.
Findings	DA	N/A	Horizontal-Generic	11	[DATESTCD]_DADAT	Product Accountability Date of Assessment	The date the study product was dispensed or returned, represented in an unambiguous date format (e.g., DD-MON-YYYY).	What was the date [DATEST] product accountability was assessed?	[DATEST] Date	Char	R/C	Record the date product accountability was performed, using this format (DD-MON-YYYY).	DADTC	This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable DADTC in ISO 8601 format.	N/A	N/A	The date study product dispensed/returned should be recorded for each dispensation for a study with multiple periods or multiple products dispensed. A single date may be collected when all observations are performed on the same date. The date of each observation can also be collected using the collection variable [DATESTCD]_DADAT. The date of the observation may be determined from a collected date of visit and in such cases a separate measurement date field is not required. This is an example the type of collection variable names that can be used in a denormalized data structure.
Findings	DA	N/A	Horizontal-Generic	12	[DATESTCD]_DAORRES	DA Assessment Result in Original Units	Result of the product accountability assessment (e.g., actual amount).	What is the amount of the [DATEST] product accountability assessment?	[DATEST] Amount	Char	HR	Record the result of the product accountability assessment.	DAORRES; DATEST; DATESTCD	Maps directly to the tabulation variable listed in the Tabulation Target column. In addition to the tabulation variable DAORRES, create DATESTCD from the collection variable name and derive the value of DATEST from DATESTCD. The prompt may also contain DATEST. Use appropriate CDISC Controlled Terminology for the test and test code.	N/A	N/A	Each test may be collected using the collection variable [TESTCD] (e.g., RETAMT) or [TESTCD]_DAORRES, where TESTCD is the appropriate CT for the DA test code (e.g., RETAMT_DAORRES). For a study with multiple periods or multiple products dispensed, accountability amounts should be assessed for each dispensation and return. For the tabulation dataset, DAREFID should be used to link related records. This is an example of the types of collection variable names that can be used in a denormalized data structure.
Findings	DA	N/A	Horizontal-Generic	13	[DATESTCD]_DAORRESU	DA Original Units	The unit of the result as originally received or collected.	What was the unit of the [DATEST] result?	[DATEST] Unit	Char	HR	Record or select the original units in which these data were collected, if not pre-printed on CRF.	DAORRESU	Maps directly to the tabulation variable listed in the Tabulation Target column.	(UNIT)	(DAORRESU)	The unit should be pre-printed on the CRF or a field provided on the CRF to capture it. This is an example of the types of collection variable names that can be used in a denormalized data structure.
Findings	DA	N/A	N/A	1	STUDYID	Study Identifier	A unique identifier for a study.	What is the study identifier?	[Protocol/Study]	Char	HR	N/A	STUDYID	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during tabulation dataset creation.
Findings	DA	N/A	N/A	2	SITEID	Study Site Identifier	A unique identifier for a site within a study.	What is the site identifier?	Site (Identifier)	Char	HR	N/A	DM.SITEID	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. EDC: This should be pre-populated.
Findings	DA	N/A	N/A	3	SUBJID	Subject Identifier for the Study	A unique subject identifier within a site and a study.	What is the subject identifier?	Subject	Char	HR	Record the identifier for the subject.	DM.SUBJID	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation domain.
Findings	DA	N/A	N/A	4	VISIT	Visit Name	The name of an encounter that encompasses planned and unplanned study interventions, procedures, and assessments that may be performed on a subject.	What is the visit name?	[Visit]	Char	R/C	N/A	VISIT	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	The name of the clinical encounter is typically pre-printed on the CRF or displayed in the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.
Findings	DA	N/A	N/A	5	VISDAT	Visit Date	Date the encounter occurred (or started).	What [is/was] the date of the visit?	(Visit) Date	Char	R/C	Record the [date/start date] of the visit using this format (DD-MON-YYYY).	N/A	This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable DADTC in ISO 8601 format.	N/A	N/A	The date the accountability assessments were collected can be determined from the Visit Date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the DA CRF using the date (DADAT) field.
Findings	DA	N/A	N/A	6	DAPERF	Product Accountability Performed	An indication of whether a planned product accountability assessment was performed.	Was product accountability performed?	Product Accountability Performed	Char	O	Indicate whether or not product accountability was performed.	DASTAT	This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable DASTAT. If DAPERF="N", the value of DASTAT will be "NOT DONE". If DAPERF="Y", DASTAT should be null. A combination of tabulation variables ( e.g., DACAT and DASCAT, DATPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable DATESTCD would be populated as DAALL and an appropriate test name (DATEST) provided.	(NY)	N/A	This may be implemented on a CRF page level on a visit-by-visit basis. This general prompt question is used as a data management tool to verify that missing results are confirmed missing.
Findings	DA	N/A	N/A	7	DACAT	DA Category of Assessment	A grouping of topic-variable values based on user-defined characteristics.	What was the type of product for which accountability was assessed?	[Product Type]; NULL	Char	O	Record the type of product dispensed/returned.	DACAT	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer.
Findings	DA	N/A	N/A	8	DASCAT	DA Subcategory of Assessment	A sub-division of the DACAT values based on user-defined characteristics.	What was the name of the product for which product accountability was assessed?	[Product Name]; NULL	Char	O	Record the name of the study product dispensed/returned.	DASCAT	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. If known at the time of data collection, the product name may be collected in DASCAT (with appropriate grouping values, but different from those for DACAT). See tabulation DA domain examples for populating DACAT and DASCAT. DASCAT can only be used if there is an DACAT, and it must be a subcategorization of DACAT.
Findings	DA	N/A	N/A	9	DADAT	Product Accountability Date	The date the study product was dispensed or returned, represented in an unambiguous date format (e.g., DD-MON-YYYY).	What was the date the product accountability assessment was performed?	Date	Char	R/C	Record the exact date the study product was (dispensed or returned), using this format (DD-MON-YYYY).	DADTC	This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable DADTC in ISO 8601 format.	N/A	N/A	The date investigational product dispensed/returned should be recorded for each dispensation for a study with multiple periods or multiple products dispensed.
Findings	DA	N/A	N/A	10	DAREFID	Product Accountability Reference ID	An internal or external identifier such as product label identifier.	What was the product label identifier?	Product Label Identifier	Char	O	Record product label identifier.	DAREFID	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	For the tabulation dataset, DAREFID should be used to tie together a block of related records and to link dispensed product to returned product. The packaging identifier may be collected in different ways (e.g., affixing label onto CRF, scanning a bar code). For some cases, greater granularity for product identifiers may be needed. In this situation, applicants may need to use additional identifier variables.
Findings	DA	N/A	N/A	11	DATEST	Name of Accountability Assessment	Descriptive name of the measurement or finding (e.g., dispensed, returned).	What was the product accountability being assessed?	[Product Accountability Test Name]	Char	HR	Record the name of the product accountability assessment if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.	DATEST; DATESTCD	Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable DATESTCD may be determined from the value collected in the collection field DATEST. The tabulation variables DATESTCD and DATEST are required in the tabulation datasets. Use appropriate CDISC Controlled Terminology for the test and test code.	(DATEST)	N/A	Required to identify which test the result is for. It is recommended that the test names pre-printed on the CRF rather than collected in a field that requires the site to enter text. If the form is laid out as a grid, then words such as "Test" can be included as the column heading. For a study with multiple periods or multiple products dispensed, product accountability amounts should be assessed for each dispensation.
Findings	DA	N/A	N/A	12	DAORRES	DA Assessment Result in Original Units	Result of the product accountability assessment as originally dispensed or returned (e.g., actual amount).	What is the result of the product accountability assessment?	Amount	Char	HR	Record the actual amount of product dispensed or returned.	DAORRES	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	For a study with multiple periods or multiple products dispensed, product accountability amounts should be assessed for each dispensation.
Findings	DA	N/A	N/A	13	DAORRESU	DA Original Units	The unit of the result as originally received or collected.	What was the unit?	Unit	Char	HR	Record or select the original units in which these data were collected, if not pre-printed on CRF.	DAORRESU	Maps directly to the tabulation variable listed in the Tabulation Target column.	(UNIT)	(DAORRESU)	Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field.

Assumptions

The CRF collects the amount of study product transferred to or from the study subject. Hence, if no study product is transferred to a subject this CRF may not be needed.
Product accountability may be implemented for an entire study or on a visit-by-visit basis depending on the most logical approach for the protocol.

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CDASH Product Accountability (DA)