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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:

  1. 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.
    1. Fixed defined time points (e.g., 4 HRS POSTDOSE)
    2. Across a collection interval (e.g., 2-4 HRS POSTDOSE)
  2. 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 ClassDomainData Collection ScenarioImplementation OptionsOrder NumberCollection VariableCollection Variable LabelDRAFT Collection DefinitionQuestion TextPromptData TypeCollection CoreCase Report Form Completion InstructionsTabulation TargetMapping InstructionsControlled Terminology Codelist NameSubset Controlled Terminology/CDASH Codelist NameImplementation Notes
FindingsPCPK Sample Collection at Fixed Time PointsN/A1STUDYIDStudy IdentifierA unique identifier for a study.What is the study identifier?[Protocol/Study]CharHRN/ASTUDYIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AAlthough 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.
FindingsPCPK Sample Collection at Fixed Time PointsN/A2SITEIDStudy Site IdentifierA unique identifier for a site within a study.What is the site identifier?Site (Identifier)CharHRN/ADM.SITEIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/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.

FindingsPCPK Sample Collection at Fixed Time PointsN/A3SUBJIDSubject Identifier for the StudyA unique subject identifier within a site and a study.What [is/was] the (study) [subject/participant] identifier?[Subject/Participant] (Identifier)CharHRRecord the identifier for the subject.DM.SUBJIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/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.

FindingsPCPK Sample Collection at Fixed Time PointsN/A4VISITVisit NameThe 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]CharR/CN/AVISITMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThe 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.
FindingsPCPK Sample Collection at Fixed Time PointsN/A5VISDATVisit DateDate the encounter occurred (or started).What [is/was] the date of the visit?(Visit) DateCharR/CRecord the [date/start date] of the visit using this format (DD-MON-YYYY).N/AThis 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/AN/AThe 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.
FindingsPCPK Sample Collection at Fixed Time PointsN/A6PCPERFPK Sampling PerformedAn indication of whether PK samples were collected.Were PK samples collected?CollectedCharOCheck "No" if none of the samples were collected.PCSTATThis 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/AGeneral 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.
FindingsPCPK Sample Collection at Fixed Time PointsN/A7PCSTATPK Sampling Completion StatusThis 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 DoneCharHRIndicate if the specimen was not done.PCSTATMaps directly to the tabulation variable listed in the Tabulation Target column.(ND)N/AA 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.
FindingsPCPK Sample Collection at Fixed Time PointsN/A8PCREASNDPK Sampling Reason Not DoneAn explanation for why the data are not available.What was the reason the PK sample was not collected?Reason Not CollectedCharOProvide the reason why a PK sample was not collected.PCREASNDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThe 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.
FindingsPCPK Sample Collection at Fixed Time PointsN/A9PCDATPK Sample Collection DateThe 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 DateCharHRRecord 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).PCDTCThis 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/AN/AA 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.
FindingsPCPK Sample Collection at Fixed Time PointsN/A10PCDATFLPK Sampling Date FlagFlag 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) DateCharOSelect 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/ADoes not map to a tabulation variable.N/AN/AWhen 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.
FindingsPCPK Sample Collection at Fixed Time PointsN/A11PCTIMPK Sample Collection TimeThe 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 TimeCharHRRecord time of collection (as complete as possible).PCDTCThis 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/AN/AA 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.
FindingsPCPK Sample Collection at Fixed Time PointsN/A12PCTPTPK Sampling Planned Time Point NameA 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]CharR/CRecord 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.PCTPTMaps 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/AN/APlanned 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.
FindingsPCPK Sample Collection at Fixed Time PointsN/A13PCCONDPK Sampling Test Condition MetIndication of whether the testing conditions defined in the protocol were met.Were the protocol-defined testing conditions met?Test Condition MetCharR/CRecord whether protocol-defined testing conditions were met.SUPPPC.QVALThis 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/AThis 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.
FindingsPCPK Sample Collection at Fixed Time PointsN/A14PCREFIDPK Sampling Reference IDAn internal or external identifier (e.g., specimen identifier).What was the (PK) [reference identifier/accession number]?(PK) [Reference Identifier/Accession Number]CharORecord the specimen or accession number assigned.PCREFIDMaps 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/AN/AThis can be used to reconcile CRF data. May be included for linking back to specimens (e.g., Specimen ID).
FindingsPCPK Sample Collection at Fixed Time PointsN/A15PCSPECPK Sampling Specimen TypeThe type of specimen used for a PK sample.What was the specimen (material) type?[Specimen Type]CharHRRecord the specimen material type, if not pre-printed on the CRF.PCSPECMaps directly to the tabulation variable listed in the Tabulation Target column.(SPECTYPE)N/AThe type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.
FindingsPCPK Sample Collection at Fixed Time PointsN/A16PCTESTPK Sampling Test NameDescriptive name of the analyte or specimen characteristics used to obtain the PK measurement or finding.What was the test name?[Test Name]CharORecord 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; PCTESTCDMaps 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/AN/AApplicants 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.
FindingsPCPK Sample Collection at Fixed Time PointsN/A17PCORRESPK Sampling Result in Original UnitsResult of the measurement or finding as originally received or collected.What was the result of the test?(Result)CharORecord the test result, interpretation, or finding.PCORRESMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AShould be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field.
FindingsPCPK Sample Collection at Fixed Time PointsN/A18PCORRESUPK Sampling Original UnitsThe unit of the result as originally received or collected.What was the unit of the result?UnitCharOSelect the original unit in which these data were collected, or record if not pre-printed on CRF.PCORRESUMaps directly to the tabulation variable listed in the Tabulation Target column.(UNIT)N/AShould be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field.
FindingsPCPK Sample Collection over a Time IntervalN/A1STUDYIDStudy IdentifierA unique identifier for a study.What is the study identifier?[Protocol/Study]CharHRN/ASTUDYIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AAlthough 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.
FindingsPCPK Sample Collection over a Time IntervalN/A2SITEIDStudy Site IdentifierA unique identifier for a site within a study.What is the site identifier?Site (Identifier)CharHRN/ADM.SITEIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/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.

FindingsPCPK Sample Collection over a Time IntervalN/A3SUBJIDSubject Identifier for the StudyA unique subject identifier within a site and a studyWhat is the subject identifier?SubjectCharHRRecord the identifier for the subject.DM.SUBJIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/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.

FindingsPCPK Sample Collection over a Time IntervalN/A4VISITVisit NameThe 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]CharR/CN/AVISITMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThe 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.
FindingsPCPK Sample Collection over a Time IntervalN/A5VISDATVisit DateDate the encounter occurred (or started)What [is/was] the date of the visit?(Visit) DateCharR/CRecord the [date/start date] of the visit using this format (DD-MON-YYYY).N/AThis 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/AN/AThe 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.
FindingsPCPK Sample Collection over a Time IntervalN/A6PCPERFPK Sampling PerformedAn indication of whether PK samples were collectedWere PK samples collected?CollectedCharOIndicate whether all of the PK samples in this group were collected.PCSTATThis 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/AThis 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.
FindingsPCPK Sample Collection over a Time IntervalN/A7PCREASNDPK Sampling Reason Not DoneAn explanation for why the data are not availableWhat was the reason the PK sample was not collected?Reason Not CollectedCharOProvide the reason why a PK sample was not collected.PCREASNDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThe 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.
FindingsPCPK Sample Collection over a Time IntervalN/A8PCDATPK Sample Collection DateThe 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 DateCharHRRecord 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).PCDTCThis 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/AN/AA 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.
FindingsPCPK Sample Collection over a Time IntervalN/A9PCTIMPK Sample Collection TimeThe 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 TimeCharHRRecord start time of collection (as complete as possible).PCDTCThis 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/AN/AA 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.
FindingsPCPK Sample Collection over a Time IntervalN/A10PCENDATPK Sample Collection End DateThe 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 DateCharHRRecord the date when PK sample collection stopped using this format (DD-MON-YYYY)PCENDTCThis 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/AN/AThe end date of specimen collection may be determined from the date of visit and if so, a separate assessment date field is not required.
FindingsPCPK Sample Collection over a Time IntervalN/A11PCENTIMPK Sample Collection End TimeThe 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 TimeCharHRRecord end time of collection (as complete as possible).PCENDTCThis 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/AN/AA 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.
FindingsPCPK Sample Collection over a Time IntervalN/A12PCTPTPK Sampling Planned Time Point NameA text description of planned time points when measurements should be taken, as defined in the protocolWhat was the planned time point of the PK sample collection?[Planned Time Point Name]CharR/CRecord 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.PCTPTMaps 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/AN/APlanned 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.
FindingsPCPK Sample Collection over a Time IntervalN/A13

PCFAST TOBA-149 - Getting issue details... STATUS

PK Sampling Fasting StatusAn indication that the subject has abstained from food/water for the specified amount of timeWas the subject fasting?FastingCharR/CRecord whether the subject was fasting prior to the test being performed.PCFASTMaps directly to the tabulation variable listed in the Tabulation Target column.(NY)N/ATo be used when results may be affected by whether the subject was fasting.
FindingsPCPK Sample Collection over a Time IntervalN/A14PCCONDPK Sampling Test Condition MetIndication 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 MetCharR/CRecord whether protocol-defined testing conditions were met.SUPPPC.QVALThis 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/AThis 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.
FindingsPCPK Sample Collection over a Time IntervalN/A15PCREFIDPK Sampling Reference IDAn internal or external identifier (e.g., specimen identifier)What was the (PK) [reference identifier/accession number]?(PK) [Reference Identifier/Accession Number]CharORecord the specimen or accession number assigned.PCREFIDMaps 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/AN/AThis can be used to reconcile CRF data. May be included for linking back to specimens (e.g., Specimen ID).
FindingsPCPK Sample Collection over a Time IntervalN/A16PCSPECPK Sampling Specimen TypeThe type of specimen used for a PK sampleWhat was the specimen (material) type?Specimen TypeCharHRRecord the specimen material type, if not pre-printed on the CRF.PCSPECMaps directly to the tabulation variable listed in the Tabulation Target column.(SPECTYPE)N/AThe type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.
FindingsPCPK Sample Collection over a Time IntervalN/A17PCTESTPK Sampling Test NameDescriptive name of the analyte or specimen characteristics used to obtain the PK measurement or findingWhat was the test name?[Test Name]CharORecord 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; PCTESTCDMaps 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/AN/AApplicants 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.
FindingsPCPK Sample Collection over a Time IntervalN/A18PCORRESPK Sampling Result in Original UnitsResult of the measurement or finding as originally received or collectedWhat was the result of the test?(Result)CharORecord the PK sampling test result.PCORRESMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/ABoth quantitative results and interpretive findings or summaries may be recorded here.
FindingsPCPK Sample Collection over a Time IntervalN/A19PCORRESUPK Sampling Original UnitsThe unit of the result as originally received or collectedWhat was the unit of the result?UnitCharORecord the PK sampling test result.PCORRESUMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/ABoth 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

  1. 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. 
  2. 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.
  3. 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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