Contents |
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Purpose
Record detailed information about the collection of biological samples for analysis of the presence and quantity of the study agent and/or its metabolites. Since this form is intended to stand alone, some of the fields may duplicate items found in other case report forms.
Pharmacokinetics eCRF
Field Name | Description / Instructions | Format |
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Visit Date(m) | Enter the date the study agent administration was started. | DD-MMM-YYYY |
Course Number(d) | Course number derived from the study agent start date and course initiation start dates. | 5 digits |
Day in Course(d) | Number of days since the start of the course. Derived from the study agent start date and course initiation start dates. | 5 digits |
Study Agent(m) | Enter the name of the study agent ( investigational or commercial ) which is the subject of the pharmacokinetic 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. |
Start Date(m) | Enter the date the study agent administration was started. | DD-MMM-YYYY |
Start Time(m) | Enter the time the study agent administration began. | HH(24):MM |
Stop Date | Enter the date the study agent administration was stopped Note: This field will be used for infusional therapies only. | DD-MMM-YYYY |
Stop Time | Enter the time the study agent administration was stopped. Note: This field will be used for infusional therapies only. | HH(24):MM |
Specimen Sampled(m) | Select the body fluid that is being collected for the biological samples. Note: Urine sample collection will be documented on the Urinary Excretion Case Report Form. | Use pick list. |
Planned Interval | Planned interval pre-determined per protocol. | 80 characters |
Sample Collected?(m) | Indicate whether or not the specimen is collected. | Use pick list. |
Actual Start Date | Enter the specimen collection date. | DD-MMM-YYYY |
Actual Start Time | Enter the specimen collection time. | HH(24):MM |
Time Interval(d) | Actual interval in minutes from the study agent start time. | 6 digits |
Parent Study Agent Assay 1 | Enter the results of the parent assay for the study agent indicated in the study agent field. | 8 digits and 3 decimals |
Parent Study Agent Assay 2 | If the planned interval time point specimen was tested a second time, enter the results of the second parent assay for the study agent indicated in the study agent field. | 8 digits and 3 decimals |
Parent Study Agent Assay Mean | Enter the parent study agent assay mean concentration, if available. Note: This will not be completed if a second assay result is not available. | 8 digits and 3 decimals |
Parent Study Agent Assay UOM | Select the appropriate concentration units of measurement for the parent study agent assay(s) (e.g.: mg/dL or mmol/l). | Use pick list. |
Metabolite Assay 1 | If applicable, enter the first metabolite assay results for the parent study agent. | 8 digits and 3 decimals |
Metabolite Assay 2 | If applicable, enter the second metabolite assay results in the biological samples. | 8 digits and 3 decimals |
Metabolite Assay Mean | Enter the metabolite assay mean concentration, if available. Note: This will not be completed if a second assay result is not available. | 8 digits and 3 decimals |
Metabolite Assay UOM | Select the appropriate concentration units of measurement for the metabolite assays (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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PHM01 | Start Date is less than or equal to the Enrollment Date of informed consent signed. | Start Date must be after the Enrollment Date of informed consent signed. |
PHM02 | Start Date is in the future. | Enter a date earlier than or equal to the current date. |
PHM05 | Start Date / Time pair appears more than once – duplicate entry. | Remove the duplicate record or correct the Start Date / Time of one of them. |
PHM06 | Parent Study Agent UOM entered, but Assay 1, Assay 2 and Mean Concentration are missing. | Enter a Parent Study Agent Assay 1, Assay 2 and/or Mean Concentration. |
PHM07 | Parent Study Agent Assay 1, Assay 2 and/or Mean Concentration entered, but UOM is missing. | Enter the Parent Study Agent UOM. |
PHM08 | Metabolite UOM entered, but Assay 1, Assay 2 and Mean Concentration are missing. | Enter a Metabolite Assay 1, Assay 2 and Mean Concentration. |
PHM09 | Metabolite Assay 1, Assay 2 and/or Mean Concentration entered, but UOM is missing. | Enter the Metabolite UOM. |
PHM15 | Stop Date is in the future. | Enter a date earlier than or equal to the current date. |
PHM16 | A Study Medication with a Medication/Agent matching the Pharmacokinetic with the same administration Date and Time was not found. Note: Study Medications with the following routes are ignored: PO, CIV and Topical. | Verify that the pharmacokinetics study agent administration is recorded on the study medication form. |
PHM17 | Collected Pharmacokinetics samples does not have corresponding Date and Time. | Enter Actual Start Date and Time if ‘Sample Collected’ is ‘YES’. |
Derivations
Code | Field Name | Description |
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PHM1001 | Course # | Course Number is derived from the Study Agent Start Date and the Course Initiation Start Dates. |
PHM1002 | Day in Course | Day in course is derived from the Study Agent Start Date and the Course Initiation Start Dates |
PHM1003 | Time Interval | Actual Time Interval is derived from the Actual Date and Time and the Start Date and Time. |