Contents |
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Purpose
Record detailed information about the collection of urine samples for analysis of the presence and quantity of the study medication and/or its metabolites.
Note: This CRF will be put on the cycle section.
Urinary Excretion eCRF
Field Name | Description / Instructions | Format |
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Visit Date | The Visit Date is optional on this case report form. Hit the "Tab" key to leave it empty and move to the Date of Dosing field. | DD-MMM-YYYY |
Course Number(d) | Indicates the course number that this urinary excretion sample is related to as derived from the course initiation start date. | 5 digits |
Day in Course(d) | Indicates the day since the beginning of course that this urinary excretion sample is related to as derived from the course initiation start date. | 5 digits |
Start Date of Dosing(m) | Enter the date the study agent was administered. | DD-MMM-YYYY |
Start Time of First Injection(m) | Enter the time of the first injection of the study agent, or if appropriate, for taking the study agent via any "non-IV" route of administration (for example, enter the time that the agent is administered orally or rectally). | HH(24):MM |
Study Agent(m) | Enter the name of the study agent (investigational or commercial) which is the subject of the urinary excretion study. Note: Only one study agent is allowed per case report form. Separate forms should be used when more than one study agent is being studied. | Use pick list. |
Stop Date of Dosing | Enter the date the study agent administration was stopped. Note: This field will be used for infusional therapies only. | DD-MMM-YYYY |
Stop Time of First Injection | Enter the stop time of the first injection of the study agent, or if appropriate, for taking the study agent via any "non-IV" route of administration (for example, enter the time that the agent is administered orally or rectally). Note: This field will be used for infusional therapies only. | HH(24):MM |
Planned Interval | Planned interval pre-determined per protocol. | 80 characters |
Sample Collected?(m) | Indicate whether or not the specimen is collected. | Use pick list. |
Start Date | Enter the collection start date. | DD-MMM-YYYY |
Start Time | Enter the collection start time even if the assay results are not available. | HH(24):MM |
Stop Date | Enter the collection end date. | DD-MMM-YYYY |
Stop Time | Enter the collection end time even if the assay results are not available. | HH(24):MM |
Urine Volume | Enter the urine volume collected in milliliters. | 4 digits. |
Parent Study Agent Assay 1 | Enter the first parent study agent assay results in the biological samples. | 8 digits and 3 decimals |
Parent Study Agent Assay 2 | Enter the second parent study agent assay results in the biological samples. | 8 digits and 3 decimals |
Parent Study Agent Assay Mean Concentration | Enter the parent study agent assay mean concentration, if available. | 8 digits and 3 decimals |
Parent Study Agent in Void | Enter the parent study agent assay in void results in the biological samples. | 8 digits and 3 decimals |
Parent Study Agent UOM | Select the appropriate Study Agent units of measurement (e.g.: mg/dL or mmol/l). | Use pick list. |
Metabolite Assay 1 | Enter the first metabolite assay results in the biological samples. | 8 digits and 3 decimals |
Metabolite Assay 2 | Enter the second metabolite assay results in the biological samples. | 8 digits and 3 decimals |
Metabolite Mean Concentration | Enter the metabolite mean concentration, if available. | 8 digits and 3 decimals |
Metabolite in Void | Enter the metabolite in void results in the biological samples. | 8 digits and 3 decimals |
Metabolite UOM | Enter the appropriate Metabolite units of measurement (e.g.: mg/dL or mmol/l). | Use pick list. |
Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.
Validations
Code | Description | Resolutions |
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UE01, UE02, | Urinary excretion dates are in the future. | Enter dates that are equal to or prior to the current date. |
UE06 | Collection End Date/Time is prior to the collection Start Date/Time. | Collection End Date/Time must be after the collection Start Date/Time. |
UE08 | Start Date / Time and Stop Date / Time pair appears more than once – duplicate entry. | Remove the duplicate record or correct the Start Date / Time and Stop Date / Time of one of them. |
UE11 | Study Agent UOM entered, but Assay 1, Assay 2, Mean Concentration and Amount in Void are missing. | Enter a Study Agent Assay 1, Assay 2, Mean Concentration and/or Amount in Void. |
UE12 | Study Agent Assay 1, Assay 2, Mean Concentration and/or Amount in Void entered, but UOM is missing. | Enter the Study Agent UOM. |
UE13 | Metabolite UOM entered, but Assay 1, Assay 2, Mean Concentration and Amount in Void are missing. | Enter a Metabolite Assay 1, Assay 2, Mean Concentration and/or Amount in Void. |
UE14 | Metabolite Assay 1, Assay 2, Mean Concentration and/or Amount in Void entered, but UOM is missing. | Enter the Metabolite UOM. |
UE16 | Collected Urinary Excretion sample does not have corresponding Start Date, Time and Urine volume. | Enter Start Date, Time and Urine Volume if ‘Sample Collected’ is ‘YES’. |
Derivations
Code | Field Name | Description |
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UE1001 | Course # | Course number is derived based on the course initiation start dates and the infection episode onset date. |
UE1002 | Day in Course | Number of days since the beginning of the course is derived from the course initiation start date and the infection episode onset date. |