- Created by Darcy Wold, last modified by Alana St. Clair on Apr 25, 2024
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 consumed by the subject or the subject's compliance. 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 study product. The term returned refers to when the subject returns the unused study product to the investigational site.
Specification
TIG v1.0 Metadata Check for CDASH Domain Specification Table Beta 2
Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes
| 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.
- No labels
Overview
Content Tools