| Question Text | Prompt | Type | CDASH Variable Name | CDASH Core | Case Report Form completion instructions | Implementation Instructions | SDTM Variable Name | SDTM Core | Mapping Instructions | Codelist | Permissible values | Pre-specified value | Hide? |
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| Was the meal tolerance testing procedure performed? | Meal tolerance testing performed | boolean | MTTYN | O | Indicate whether or not the meal tolerance testing procedure was performed. | The primary intent/purpose of collecting this field is to help with data cleaning and monitoring. The sponsor may map a response of "No" as directed to document testing that was not performed. A response of "Yes" will not be mapped to the SDTM data. Because this field does not map to an SDTM domain, the sponsor may assign a naming prefix according to internal conventions. | N/A | N/A | Mapping this field to SDTM is optional. If this field is not mapped to SDTM, annotate the field as "Not Submitted". If the sponsor chooses to map to SDTM, a response of "Yes" is not submitted. A response of "No" is mapped to AGSTAT and LBSTAT as the value "NOT DONE". In the LB domain, LBTESTCD will be "LBALL", LBTEST will be "Lab All" and a value must be assigned to LBCAT to distinguish the meal tolerance testing panel. | | | | |
| Was the meal for meal tolerance testing administered? | Meal administration done | boolean | AGOCCUR | O | Indicate whether or not the meal for meal tolerance testing was administered. | This is intended to be used as a data management tool to verify that missing results are confirmed missing. See Best Practice Section 3.4, FAQ #6. The question text used might be reflected in the reason not done (AGREASND). | AGOCCUR | Perm | If the sponsor chooses to map to SDTM, a response of "Yes" is not submitted. A response of "No" is mapped to AGSTAT as the value "NOT DONE". | | | | |
| What was the planned time point (numeric) of the meal? | N/A | integer | N/A | N/A | N/A | This is a numeric code and would not typically appear on the (e)CRF | AGTPTNUM | Exp | N/A | | | | |
| Planned time point of the meal | [Time point (text) of meal[] | text | AGTPT | O | Record the planned time point of meal. Can be pre-printed. | Text description of planned time point when the meal should be taken. Use when multiple sequential assessments are done. Typically preprinted on the CRF. Expected values - Morning Meal, Mid-day Meal, Evening Meal, Snack, Nutritional Bar, Standardized Meal Sponsors must ensure that subjects with reversed sleep wake cycles (i.e., shift workers) use the terms as others would even though they do not match. In other words, "Morning Meal" will be shift workers' "breakfast' even though they are waking and breaking their fast late in the day. | AGTPT | Perm | Maps directly to SDTM. | | | | |
| Meal Date | Meal Date | date | AGSTDAT | HR | Record the meal date using this format (DD-MMM-YYYY). | CDASH recommends the unambiguous format DD-MMM-YYYY where “DD” is the day as a 2-digit numeric value, “MMM” is the month as a 3-character letter abbreviation in English, or similar character abbreviation or representation in the local language, and “YYYY” is the year as a 4-digit numeric value. | AGSTDTC | Exp | For the SDTM-based dataset, the SDTM IG variable AGSTDTC is derived by concatenating CDASH Start Date (AGSTDAT) and Time (AESTTIM if time is collected) and converting to the ISO 8601 format. For more detail see the CDASH v1.1 Best Practice section This field does not map directly into SDTM. | | | | |
| Meal Start Time | Start Time | time | AGSTTIM | HR | Record the meal start time. | | AGSTDTC;LBRFTDTC | Exp | For the SDTM-based dataset, the SDTM IG variable AGSTDTC is derived by concatenating CDASH Start Date (AGSTDAT) and Time (AESTTIM if time is collected) and converting to the ISO 8601 format. The same data is also used to populate the reference date LBRFTDTC. For more detail see the CDASH v1.1 Best Practice section This field does not map directly into SDTM. | | | | |
| Meal End Time | End Time | time | AGENTIM | HR | Record the mean end time. | If the meal could end on a later date than it began, AGENDAT would also be collected on the (e)CRF. | AGENDTC | Exp | For the SDTM-based dataset, the SDTM IG variable AGENDTC is derived by concatenating the date the meal ended with eth time the meal ended and converting to ISO 8601 format. In most cases the end date will be the same as the start date so CDASH Start Date (AGSTDAT) and End Time (AEENTIM if time is collected) would be concatenated and converting to the ISO 8601 format. For more detail see the CDSH v1.1 Best Practice section This field does not map directly into SDTM. | | | | |
| What portion of the meal was consumed? | Portion of meal consumed | text | AGDSTXT | HR | Record the portion of the meal consumed. | Where this level of dosing information is required by a sponsor, this field may be included. Defining this data collection field as a dose text field allows for flexibility in capturing dose entries as numbers, text or ranges. If the sponsor wishes, it is permissible to collect separate values for the amount of meal (solid agent) and amount of drink (liquid agent) consumed. Modify the question text (or prompt) and the CDASH variable name appropriately. | AGDOSTXT | Perm | This field does not map directly to an SDTM variable. The data collected in this dose text-format field should be separated or mapped to either SDTM IG AGDOSE if numeric or AGDOSTXT if text. If the sponsor wishes to collect separate values for the amount of food and the amount of drink consumed, the data will map to SDTM as two records. The records will share the values for most other variables (AGTPT, AGSTDTC, AGENDTC, etc.). Adjust the values for AGTRT and AGDOSTXT accordingly. | | <25%;≥25% to <50%;≥50% to <75%;≥75% to <100%;100% | | |
| N/A | N/A | text | LBSCAT | HR | N/A | To be included if lab status is collected for the entire panel (e.g., "Meal Tolerance"). If required, this should be preprinted on the (e)CRF rather than collected in a field that requires the site to enter text. The decision to map to LBCAT or LBSCAT is made by the sponsor based upon analysis and reporting requirements. | LBSCAT | Perm | LBSCAT both map directly to SDTM. | | | Meal Tolerance | |
| [Time point (number) of blood sampling] | N/A | integer | N/A | N/A | N/A | Numeric code corresponding to a text description of time when the meal should be taken. May be preprinted on the CRF, but not typically displayed on eCRFs. | LBTPTNUM | Exp | N/A | | | | |
| Planned Timepoint | [Time point (text) of blood sampling] | text | LBTPT | O | Record the planned time point labels for the lab test, if not pre-printed on the CRF. (Expected for each planned timepoint.) | Text description of planned time point when a sample should be collected. Use when multiple sequential assessments are done. Planned time point would be needed to differentiate multiple sequential assessments. It is recommended that time points be 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 “Planned Time Point” can be included as the column header. *See the BRIDG model for complete path. | LBTPT | Perm | Maps directly to SDTM. | | Fasting/0 minutes;15 minutes postprandial;30 minutes postprandial;60 minutes postprandial;1 hour postprandial;90 minutes postprandial;120 minutes postprandial;2 hours postprandial;... | | |
| Was the sample collected? | Lab Status | boolean | LBPERF | O | Indicate whether or not the sample was collected. (Expected for each planned timepoint.) | Status of whether or not lab specimen was collected or measurement performed. This may be implemented for an entire panel, or on a specific test basis. This is intended to be used as a data management tool to verify that missing results are confirmed missing. See CDASH v1.1 Best Practice Section 3.4, FAQ #6. For the SDTM-based dataset, the SDTM-IG variable LBSTAT is derived from LBPERF when and entire panel or a specific test/sample is not done, The question text used might be reflected in the reason not done (LBREASND). Record for each sample collection timepoint. Values are Yes or No. | LBSTAT | Perm | This field does not map directly to an SDTM variable. | | | | |
| For what reason was the blood sampling not done? | Reason blood sampling not done (can be pre-specified list) | text | LBREASND | O | Record the reason blood sampling was not done. (If collected, expected for each planned timepoint.) | Can be free text or pre-specified list defined by the sponsor. | LBREASND | Perm | Maps directly to SDTM. | | | | |
| What was the blood sampling time? | Time of blood sampling | time | LBTIM | O | Record the time of blood sampling. (Expected for each planned timepoint.) | | LBDTC | Perm | For the SDTM-based dataset, the SDTM IG variable LBDTC is derived by concatenating CDASH Date (LBDAT) and Time (LBTIM if time is collected) and converting to the ISO 8601 format. For more detail see the CDSH v1.1 Best Practice section This field does not map directly into SDTM. | | | | |
| Glucose Result | Blood Glucose result | float | GLUC_LBORRES | O | Record test results (Expected for each planned timepoint.) | Result of the measurement or finding as originally received or collected. Key data collected. | LBORRES | Exp | | | | | |
| Glucose Unit | Blood Glucose unit | text | GLUC_LBORRESU | O | Record the units of the lab test, if not pre-printed on the CRF or captured in an external “lab normal” file. (Expected for each planned timepoint.) | Original units in which the data were collected. Should be included if applicable and not available elsewhere. For some lab tests the units may not be applicable (e.g., urine color). *See the BRIDG model for complete path. | LBORRESU | Exp | Maps directly to SDTM. | UNIT | mg/dl;mmol/L | | |
| Glucose Reference Range Indicator (provided with laboratory results) | | text | GLUC_LBORNRIND | O | (Expected for each planned timepoint.) | | LBNRIND | Exp | Maps directly to SDTM. | | Low;High;Normal | | |
| Insulin Result | Insulin result | float | INSULIN_LBORRES | O | Record test results (Expected for each planned timepoint.) | Result of the measurement or finding as originally received or collected. Key data collected. | LBORRES | Exp | Maps directly to SDTM. | | | | |
| Insulin Unit | Insulin unit | text | INSULIN_LBORRESU | O | Record the units of the lab test, if not pre-printed on the CRF or captured in an external “lab normal” file. (Expected for each planned timepoint.) | Original units in which the data were collected. Should be included if applicable and not available elsewhere. For some lab tests the units may not be applicable (e.g., urine color). *See the BRIDG model for complete path. | LBORRESU | Exp | Maps directly to SDTM. | UNIT | | mIU/L | |
| Insulin Reference Range Indicator (provided with laboratory results) | | text | INSULIN_LBORNRIND | O | (Expected for each planned timepoint.) | | LBNRIND | Exp | Maps directly to SDTM. | | Low;High;Normal | | |
| C-Peptide Result | C-Peptide result | float | CPEPTIDE_LBORRES | O | Record test results (Expected for each planned timepoint.) | Result of the measurement or finding as originally received or collected. Key data collected. | LBORRES | Exp | Maps directly to SDTM. | | | | |
| What was the C-peptide unit? | C-Peptide unit | text | CPEPTIDE_LBORRESU | O | Record the units of the lab test, if not pre-printed on the CRF or captured in an external “lab normal” file. (Expected for each planned timepoint.) | Original units in which the data were collected. Should be included if applicable and not available elsewhere. For some lab tests the units may not be applicable (e.g., urine color). *See the BRIDG model for complete path. | LBORRESU | Exp | Maps directly to SDTM. | UNIT | ug/l;ng/ml | | |
| C-Peptide Reference Range Indicator (provided with laboratory results) | | text | CPEPTIDE_LBORNRIND | O | (Expected for each planned timepoint.) | | LBNRIND | Exp | Maps directly to SDTM. | | Low;High;Normal | | |
| Glucose Laboratory Low Normal Reference Range (provided with laboratory results) | | float | GLUC_LBORNRLO | O | Record the lower limit of the reference range of the lab test. Expected to be captured only one time if all specimen processed from the same laboratory. | The lowest continuous numeric value of a given lab result expected in the population of interest. LBORNRLO and LBORNRHI should be populated only for continuous results; LBSTNRC should be populated only for non-continuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look up table. See SDTM IG for details on mapping and selecting the proper variable name. *See the BRIDG model for complete path. | LBORNRLO | Exp | Maps directly to SDTM. | | | | |
| Glucose Laboratory High Normal Reference Range (provided with laboratory results) | | float | GLUC_LBORNRHI | O | Record the upper limit of the reference range of the lab test. Expected to be captured only one time if all specimen processed from the same laboratory. | The highest continuous numeric value of a given lab result expected in the population of interest. LBORNRLO and LBORNRHI should be populated only for continuous results; LBSTNRC should be populated only for non-continuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look up table. See SDTM IG for details on mapping and selecting the proper variable name. *See the BRIDG model for complete path. | LBORNRHI | Exp | Maps directly to SDTM. | | | | |
| Insulin Laboratory Low Normal Reference Range (provided with laboratory results) | | float | INSULIN_LBORNRLO | O | Record the lower limit of the reference range of the lab test. Expected to be captured only one time if all specimen processed from the same laboratory. | The lowest continuous numeric value of a given lab result expected in the population of interest. LBORNRLO and LBORNRHI should be populated only for continuous results; LBSTNRC should be populated only for non-continuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look up table. See SDTM IG for details on mapping and selecting the proper variable name. *See the BRIDG model for complete path. | LBORNRLO | Exp | Maps directly to SDTM. | | | | |
| Insulin Laboratory High Normal Reference Range (provided with laboratory results) | | float | INSULIN_LBORNRHI | O | Record the upper limit of the reference range of the lab test. | The highest continuous numeric value of a given lab result expected in the population of interest. LBORNRLO and LBORNRHI should be populated only for continuous results; LBSTNRC should be populated only for non-continuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look up table. See SDTM IG for details on mapping and selecting the proper variable name. *See the BRIDG model for complete path. | LBRNRHI | Exp | Maps directly to SDTM. | | | | |
| C-Peptide Laboratory Low Normal Reference Range (provided with laboratory results) | | float | CPEPTIDE_LBORNRLO | O | Record the lower limit of the reference range of the lab test. | The lowest continuous numeric value of a given lab result expected in the population of interest. LBORNRLO and LBORNRHI should be populated only for continuous results; LBSTNRC should be populated only for non-continuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look up table. See SDTM IG for details on mapping and selecting the proper variable name. *See the BRIDG model for complete path. | LBRNRLO | Exp | Maps directly to SDTM. | | | | |
| C-Peptide Laboratory High Normal Reference Range (provided with laboratory results) | | float | CPEPTIDE_LBORNRHI | O | Record the upper limit of the reference range of the lab test. | The highest continuous numeric value of a given lab result expected in the population of interest. LBORNRLO and LBORNRHI should be populated only for continuous results; LBSTNRC should be populated only for non-continuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look up table. See SDTM IG for details on mapping and selecting the proper variable name. *See the BRIDG model for complete path. | LBRNRHI | Exp | Maps directly to SDTM. | | | | |
| Specimen Type (indicated on laboratory results) | Specimen | text | LBSPEC | O | Record the specimen. | | LBSPEC | Perm | Maps directly to SDTM. | SPECTYP | | Blood | Y |