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Description
Information about sampling for pharmacokinetic (PK) concentration is collected on CRFs with the goal to reconcile or link sampling information (e.g., collection timing and specimen volumes) with PK concentration results provided by the laboratory. SDTMIG PC records are compiled when joining CRF sampling information and PK concentration results. This is similar to scenario 1 in Section 8.3.6, Laboratory Test Results.
The goals of the CDASHIG PC domain are:
- To standardize specimen collection details in the CRF for PK samples collected at fixed time points or over timed intervals
- To provide CDASHIG examples as to the collection of data that is closely related to PK sampling (e.g., subject's most recent exposure to study treatment, exposure record considered to be the reference for timed PK samples)
- To document the data flow from the CDASHIG CRF to the SDTMIG PC dataset
The CDASHIG PC domain defines fields for:
- The date and time of PK sample collections for the scenarios listed below. Note that the sampling approach may depend on how the body metabolizes and clears the analyte.
- Fixed defined time points (e.g., 4 HRS POSTDOSE)
- Across a collection interval (e.g., 2-4 HRS POSTDOSE)
- Sample properties (e.g., pH, sample volume)
Note that samples collected to measure drug concentration at an instant in time are generally associated with specimen types such as plasma, serum, or whole blood. Samples collected over a timed interval are generally associated with specimen types such as urine or feces.
PK Sample Collection at Fixed Time Points
In the case of fixed time points, the date (PCDAT) and time (PCTIM) of collection for each sample is recorded on the CRF. The protocol defines the time points at which samples are to be collected in relation to an intervention such as a dose of study treatment. This "reference" is depicted in Figure 1 by the longer vertical line and would correspond to a date and time in the Exposure as Collected (EC) or Exposure (EX) domain.
PK Sample Collection Over a Time Interval
Similarly, for PK specimens collected to measure drug excretion over a time interval, PCDAT and PCTIM capture the start date and time of the interval collection. End date (PCENDAT) and end time (PCENTIM) capture the end of the timed interval collection. As with fixed-time point collections, these timed intervals are performed in relation to an intervention such as a dose of study treatment. This "reference" is depicted in Figure 2 by the longer vertical line and would correspond to a date and time in the EC or EX domain.
CM.CDASHIG-SDTMIG PK Data Flow
The concept map in Figure 3 illustrates the data flow from PK sample collection at the site through the tabulation of PK concentration and PK parameter results.
Specification
TIG v1.0 Metadata Check for CDASH Domain Specification Table Beta 2
Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. 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 | PC | PK Sample Collection at Fixed Time Points | 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 in the database or populated during tabulation dataset creation. |
| Findings | PC | PK Sample Collection at Fixed Time Points | 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 | PC | PK Sample Collection at Fixed Time Points | N/A | 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 collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain. |
| Findings | PC | PK Sample Collection at Fixed Time Points | 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 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 | PC | PK Sample Collection at Fixed Time Points | 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 PCDTC in ISO 8601 format. | N/A | N/A | The date the PK samples were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the PK samples at that visit, or the collection date can be collected on the PK CRF using the date (PCDAT) field. |
| Findings | PC | PK Sample Collection at Fixed Time Points | N/A | 6 | PCPERF | PK Sampling Performed | An indication of whether PK samples were collected. | Were PK samples collected? | Collected | Char | O | Check "No" if none of the samples were collected. | PCSTAT | This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable PCSTAT. If PCPERF="N", the value of PCSTAT will be "NOT DONE". If PCPERF="Y", PCSTAT should be null. PCTEST and PCTESTCD must reflect what tests were not done. A combination of tabulation variables ( e.g., PCCAT and PCSCAT, PCTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable PCTESTCD would be populated as PCALL and an appropriate test name (PCTEST) provided. | (NY) | N/A | General prompt question to be used as a data management tool to verify that missing results are confirmed missing. This may be implemented at form level or sample level. These may be all samples of a particular type or all samples taken for some purpose and may need to be identified by the organization of the data on the form. Each sample collected could result in 1 or more tests performed, so there can be a one-to-one or one-to-many relationship between samples and tests/results. |
| Findings | PC | PK Sample Collection at Fixed Time Points | N/A | 7 | PCSTAT | PK Sampling Completion Status | This variable used to indicate that data are not available, by having the site record the value as "Not Done". | Record "Not Done" if the PK sample was not collected. | Not Done | Char | HR | Indicate if the specimen was not done. | PCSTAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (ND) | N/A | A Not Done checkbox, which indicates the test was "NOT DONE". Typically, there would be 1 checkbox for each measurement. This field can be useful on individual sample collections to confirm that a blank result field is meant to be blank. |
| Findings | PC | PK Sample Collection at Fixed Time Points | N/A | 8 | PCREASND | PK Sampling Reason Not Done | An explanation for why the data are not available. | What was the reason the PK sample was not collected? | Reason Not Collected | Char | O | Provide the reason why a PK sample was not collected. | PCREASND | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | The reason the data are not available may be chosen from an applicant-defined list (e.g., broken equipment, subject refused) or entered as free text. When PCREASND is used, the tabulation variable PCSTAT should also be populated in the tabulation dataset. |
| Findings | PC | PK Sample Collection at Fixed Time Points | N/A | 9 | PCDAT | PK Sample Collection Date | The date of PK sample collection or the start date of PK sample collection over a period of time (protocol-defined time-point range), represented in an unambiguous date format (e.g., DD-MON-YYYY). | What was the date of the PK sample collection? | Collection Date | Char | HR | Record the date when PK sample collection occurred using this format (DD-MON-YYYY). If left blank, "PCDATFL" for this specimen must be populated (or "PCPERF" must be flagged to indicate this sample was not collected). | PCDTC | 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 PCDTC in ISO 8601 format. | N/A | N/A | A complete date is expected. The date of collection may be determined from the date of visit (VISDAT); if so, a separate assessment date field is not required. The tabulation PCDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time. |
| Findings | PC | PK Sample Collection at Fixed Time Points | N/A | 10 | PCDATFL | PK Sampling Date Flag | Flag indicating that the PK date (or start date) is the same as the previous specimen collection date (or start date). | Was the specimen/sample collected on the same date as the [last/previous specimen/sample] [collected/collection ended]? | Same as Previous (Specimen/Sample Collection End) Date | Char | O | Select when the date of this specimen collection is the same as the date of the previous specimen collected. If left blank, "PCDAT" for this specimen must be populated. (or "PCPERF" must be flagged to indicate this sample was not collected) | N/A | Does not map to a tabulation variable. | N/A | N/A | When a series of specimens are collected on a single form, this field is tied to the collection date to allow for the flag to be used as a surrogate for the date field. Its selection means that the date of this specimen is the same as the date of the last specimen collected (in the series). This variable may be used when collecting PK data and re-entering dates is more cumbersome than selecting the checkbox. |
| Findings | PC | PK Sample Collection at Fixed Time Points | N/A | 11 | PCTIM | PK Sample Collection Time | The time of PK sample collection or start time for a specimen collected over a period of time (protocol-defined time-point range), represented in an unambiguous time format (e.g., hh:mm:ss). | What was the time of the PK sample collection? | Collection Time | Char | HR | Record time of collection (as complete as possible). | PCDTC | 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 PCDTC in ISO 8601 format. | N/A | N/A | A complete time is expected. The tabulation PCDTC variable contains either a date/time, when a specimen is collected at a point in time, or the start date/time, when a specimen is collected over time. |
| Findings | PC | PK Sample Collection at Fixed Time Points | N/A | 12 | PCTPT | PK Sampling Planned Time Point Name | A text description of planned time points when measurements should be taken, as defined in the protocol. | What was the planned time point of the PK sample collection? | [Planned Time Point Name] | Char | R/C | Record the planned time-point labels for the PK sample collection, if not pre-printed on the CRF. Note: Planned time points are often described as relative to exposure to study product. | PCTPT | Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation time-point anchors PCTPTREF (text description) and PCRFTDTC (date/time) may be needed, as well as tabulation variables PCTPTNUM, PCELTM. | N/A | N/A | Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then terms such as "Planned Time Point" can be included in the column heading. |
| Findings | PC | PK Sample Collection at Fixed Time Points | N/A | 13 | PCCOND | PK Sampling Test Condition Met | Indication of whether the testing conditions defined in the protocol were met. | Were the protocol-defined testing conditions met? | Test Condition Met | Char | R/C | Record whether protocol-defined testing conditions were met. | SUPPPC.QVAL | This does not map directly to a tabulation variable. This information could be represented in a SUPPPC dataset as the value of SUPPPC.QVAL where SUPPPC.QNAM ="PCCOND" and SUPP.PCLABEL= "Test Condition Met". | (NY) | N/A | This information is collected when the test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF. This may not be relevant for all tests. |
| Findings | PC | PK Sample Collection at Fixed Time Points | N/A | 14 | PCREFID | PK Sampling Reference ID | An internal or external identifier (e.g., specimen identifier). | What was the (PK) [reference identifier/accession number]? | (PK) [Reference Identifier/Accession Number] | Char | O | Record the specimen or accession number assigned. | PCREFID | 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 another domain. | N/A | N/A | This can be used to reconcile CRF data. May be included for linking back to specimens (e.g., Specimen ID). |
| Findings | PC | PK Sample Collection at Fixed Time Points | N/A | 15 | PCSPEC | PK Sampling Specimen Type | The type of specimen used for a PK sample. | What was the specimen (material) type? | [Specimen Type] | Char | HR | Record the specimen material type, if not pre-printed on the CRF. | PCSPEC | Maps directly to the tabulation variable listed in the Tabulation Target column. | (SPECTYPE) | N/A | The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens. |
| Findings | PC | PK Sample Collection at Fixed Time Points | N/A | 16 | PCTEST | PK Sampling Test Name | Descriptive name of the analyte or specimen characteristics used to obtain the PK measurement or finding. | What was the test name? | [Test Name] | Char | O | Record the name of the measurement or finding, 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. | PCTEST; PCTESTCD | Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable PCTESTCD may be determined from the value collected in PCTEST. The tabulation variables PCTESTCD and PCTEST are required in the tabulation datasets. Use appropriate CDISC Controlled Terminology for the test and test code. | N/A | N/A | Applicants typically collect tests related to the specimen characteristics on the CRF (e.g., Volume, Ph). Results for tests on an analyte (e.g., Concentration) would typically be populated when creating tabulation datasets. If the analyte test results are collected on the CRF, the test would be the analyte name. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Test" can be included in the column heading. |
| Findings | PC | PK Sample Collection at Fixed Time Points | N/A | 17 | PCORRES | PK Sampling Result in Original Units | Result of the measurement or finding as originally received or collected. | What was the result of the test? | (Result) | Char | O | Record the test result, interpretation, or finding. | PCORRES | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. |
| Findings | PC | PK Sample Collection at Fixed Time Points | N/A | 18 | PCORRESU | PK Sampling Original Units | The unit of the result as originally received or collected. | What was the unit of the result? | Unit | Char | O | Select the original unit in which these data were collected, or record if not pre-printed on CRF. | PCORRESU | Maps directly to the tabulation variable listed in the Tabulation Target column. | (UNIT) | N/A | Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. |
| Findings | PC | PK Sample Collection over a Time Interval | 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 in the database or populated during tabulation dataset creation. |
| Findings | PC | PK Sample Collection over a Time Interval | 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 | PC | PK Sample Collection over a Time Interval | 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 domains. However, this collection variable is populated only in the tabulation DM domain. |
| Findings | PC | PK Sample Collection over a Time Interval | 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 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 | PC | PK Sample Collection over a Time Interval | 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, or observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable PCDTC in ISO 8601 format. | N/A | N/A | The date the PK samples were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the PK samples at that visit, or the collection date can be collected on the PK CRF using the date (PCDAT) field. |
| Findings | PC | PK Sample Collection over a Time Interval | N/A | 6 | PCPERF | PK Sampling Performed | An indication of whether PK samples were collected | Were PK samples collected? | Collected | Char | O | Indicate whether all of the PK samples in this group were collected. | PCSTAT | This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable PCSTAT. If PCPERF="N", the value of PCSTAT will be "NOT DONE". If PCPERF="Y", PCSTAT should be null. PCTEST and PCTESTCD must reflect what tests were not done. A combination of tabulation variables (e.g., PCCAT and PCSCAT, PCTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable PCTESTCD would be populated as PCALL and an appropriate test name (PCTEST) 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 at form level or sample level. These may be all samples of a particular type, or all samples taken for some purpose, and may need to be identified by the organization of the data on the form. Each sample collected could result in 1 or more tests performed, so there can be a one-to-one or one-to-many relationship between samples and tests/results. |
| Findings | PC | PK Sample Collection over a Time Interval | N/A | 7 | PCREASND | PK Sampling Reason Not Done | An explanation for why the data are not available | What was the reason the PK sample was not collected? | Reason Not Collected | Char | O | Provide the reason why a PK sample was not collected. | PCREASND | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | The reason the data are not available may be chosen from an applicant-defined list (e.g., broken equipment, subject refused) or entered as free text. When PCREASND is used, the tabulation variable PCSTAT should also be populated in the tabulation dataset. |
| Findings | PC | PK Sample Collection over a Time Interval | N/A | 8 | PCDAT | PK Sample Collection Date | The date of PK sample collection or the start date of PK sample collection over a period of time (protocol-defined time-point range), represented in an unambiguous date format (e.g., DD-MON-YYYY) | What was the date of the PK sample collection? | Collection Date | Char | HR | Record the date when PK sample collection occurred using this format (DD-MON-YYYY). If left blank, "PCDATFL" for this specimen must be populated (or "PCPERF" must be flagged to indicate this sample was not collected). | PCDTC | 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 PCDTC in ISO 8601 format. | N/A | N/A | A complete date is expected. The tabulation PCDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time. |
| Findings | PC | PK Sample Collection over a Time Interval | N/A | 9 | PCTIM | PK Sample Collection Time | The time of PK sample collection or start time for a specimen collected over a period of time (protocol-defined time-point range), represented in an unambiguous time format (e.g., hh:mm:ss) | What was the start time of the PK sample collection? | Collection Start Time | Char | HR | Record start time of collection (as complete as possible). | PCDTC | 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 PCDTC in ISO 8601 format. | N/A | N/A | A complete time is expected. In interval collection, start can be added as needed to the question text, prompt and CRF directions. The tabulation PCDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time. |
| Findings | PC | PK Sample Collection over a Time Interval | N/A | 10 | PCENDAT | PK Sample Collection End Date | The end date of the specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY) | What was the end date of the specimen collection? | (Collection) End Date | Char | HR | Record the date when PK sample collection stopped using this format (DD-MON-YYYY) | PCENDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable PCENDTC in ISO 8601 format. | N/A | N/A | The end date of specimen collection may be determined from the date of visit and if so, a separate assessment date field is not required. |
| Findings | PC | PK Sample Collection over a Time Interval | N/A | 11 | PCENTIM | PK Sample Collection End Time | The end time of the specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss) | What was the specimen collection end time? | (Collection) End Time | Char | HR | Record end time of collection (as complete as possible). | PCENDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable PCENDTC in ISO 8601 format. | N/A | N/A | A complete end time is expected. The tabulation variable PCENDTC variable contains the end date/time, when a specimen is collected over time. If there is no end date/time, the tabulation variable PCENDTC should be Null. |
| Findings | PC | PK Sample Collection over a Time Interval | N/A | 12 | PCTPT | PK Sampling Planned Time Point Name | A text description of planned time points when measurements should be taken, as defined in the protocol | What was the planned time point of the PK sample collection? | [Planned Time Point Name] | Char | R/C | Record the planned time-point labels for the PK sample collection, if not pre-printed on the CRF. Note: Planned time points are often described as relative to exposure to study product. | PCTPT | Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation time-point anchors PCTPTREF (text description) and PCRFTDTC (date/time) may be needed, as well as tabulation variables PCTPTNUM, PCELTM. | N/A | N/A | Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then terms such as "Planned Time Point" can be included in the column heading. |
| Findings | PC | PK Sample Collection over a Time Interval | N/A | 13 | PCFAST TOBA-149 - Getting issue details... STATUS | PK Sampling Fasting Status | An indication that the subject has abstained from food/water for the specified amount of time | Was the subject fasting? | Fasting | Char | R/C | Record whether the subject was fasting prior to the test being performed. | PCFAST | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | To be used when results may be affected by whether the subject was fasting. |
| Findings | PC | PK Sample Collection over a Time Interval | N/A | 14 | PCCOND | PK Sampling Test Condition Met | Indication of whether the testing conditions defined in the protocol were met (e.g., low fat diet) | Were the protocol-defined testing conditions met? | Test Condition Met | Char | R/C | Record whether protocol-defined testing conditions were met. | SUPPPC.QVAL | This does not map directly to a tabulation variable. This information could be represented in a SUPPPC dataset as the value of SUPPPC.QVAL where SUPPPC.QNAM ="PCCOND" and SUPP.PCLABEL= "Test Condition Met". | (NY) | N/A | This information is collected when the test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF. This may not be relevant for all tests. |
| Findings | PC | PK Sample Collection over a Time Interval | N/A | 15 | PCREFID | PK Sampling Reference ID | An internal or external identifier (e.g., specimen identifier) | What was the (PK) [reference identifier/accession number]? | (PK) [Reference Identifier/Accession Number] | Char | O | Record the specimen or accession number assigned. | PCREFID | 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 another domain. | N/A | N/A | This can be used to reconcile CRF data. May be included for linking back to specimens (e.g., Specimen ID). |
| Findings | PC | PK Sample Collection over a Time Interval | N/A | 16 | PCSPEC | PK Sampling Specimen Type | The type of specimen used for a PK sample | What was the specimen (material) type? | Specimen Type | Char | HR | Record the specimen material type, if not pre-printed on the CRF. | PCSPEC | Maps directly to the tabulation variable listed in the Tabulation Target column. | (SPECTYPE) | N/A | The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens. |
| Findings | PC | PK Sample Collection over a Time Interval | N/A | 17 | PCTEST | PK Sampling Test Name | Descriptive name of the analyte or specimen characteristics used to obtain the PK measurement or finding | What was the test name? | [Test Name] | Char | O | Record the name of the measurement or finding, 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. | PCTEST; PCTESTCD | Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable PCTESTCD may be determined from the value collected in PCTEST. The tabulation variables PCTESTCD and PCTEST are required in the tabulation datasets. Use appropriate CDISC Controlled Terminology for the test and test code. | N/A | N/A | Applicants typically collect tests related to the specimen characteristics on the CRF (e.g., Volume, pH). Results for tests on an analyte (e.g., Concentration) would typically be populated when the tabulation datasets are created. If analyte test results are collected on the CRF, the test would be the analyte name. It is recommended that test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Test" can be included in the column heading. |
| Findings | PC | PK Sample Collection over a Time Interval | N/A | 18 | PCORRES | PK Sampling Result in Original Units | Result of the measurement or finding as originally received or collected | What was the result of the test? | (Result) | Char | O | Record the PK sampling test result. | PCORRES | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Both quantitative results and interpretive findings or summaries may be recorded here. |
| Findings | PC | PK Sample Collection over a Time Interval | N/A | 19 | PCORRESU | PK Sampling Original Units | The unit of the result as originally received or collected | What was the unit of the result? | Unit | Char | O | Record the PK sampling test result. | PCORRESU | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Both quantitative results and interpretive findings or summaries may be recorded here. |
Metadata Checks Findings
Metadata Check User Macros FAQ
- For variable PK Sample Collection over a Time Interval / N/A / PCFAST, PCFAST is a not a recognized tabulation variable in Tabulation Target
Assumptions
- It is up to the applicant to determine which data collection scenario best meets the study needs. Typically, only details regarding the collection of PK samples from subjects (e.g., timing of sample collection, associated specimen properties) are collected at the investigational site. Analyte test results are provided directly to the applicant from the bioanalytical laboratory and not on a CRF. The applicant would directly populate the analyte results when creating the SDTM-based datasets.
- If the applicant has occasion to collect the analyte test results on a CRF, the test would be the analyte name. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field.
- Other data (e.g., demographics, vital signs, substance use, exposure) may be needed for PK analysis. See the TIG collection sections for these related domains.
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