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Purpose
Record the details of research samples collected for each patient per protocol requirements.
Specimen Status eCRF
Field Name | Description / Instructions | Format | ||
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Visit Date(m) | Enter the date the form was completed.
| DD-MMM-YYYY | ||
Specimen ID | Enter Specimen ID (Identifier) | 30 Characters | ||
Expected Collection Date of Specimen | Enter the planned or anticipated date when a sample (specimen) will be collected. | DD-MMM-YYYY | ||
Expected Collection Time of Specimen | Enter the planned or anticipated time when a sample (specimen) will be collected in military format (24 hours). Seconds are optional and default to 00 if not entered. Ex: 13:56:00 (for 1:56:00 PM)
In RDC Onsite studies, the lab time will be empty when the CRF is saved with time 00:00:00. Such time is being saved and simply not being displayed. There is no way to indicate an 'unknown' lab time right now. | HH(24):MM:SS | ||
Specimen Collected? | Select a Yes/ No/ Not Applicable answer to whether a sample/ specimen has been collected | Use pick list. | ||
Collection Date | Enter the date when sample was collected. | DD-MMM-YYYY | ||
Specimen Type | Select specimen type from the pick list:
| Use pick list. | ||
Submitted Reason | Select the explanation for the submission of a biospecimen from a patient. | Use pick list. | ||
Other, Specify | Enter the explanation for submission of a specimen that is different from a list of options. | 100 characters | ||
Amount Obtained | Enter the number that describes the amount of specimen included in the sample. | 5 digits and 2 decimals | ||
Specimen Unit | Enter the unit of measurement applied to a biospecimen collection. | Use pick list. | ||
Reason Specimen Not Collected | Select the reason a tissue specimen taken for research or analysis was not collected from the picklist:
| Use pick list. | ||
Reason Specimen Not Collected; Other, specify | Use the free-text field to specify the reason a tissue specimen taken for research or analysis was not collected. | 100 characters |
Legend: (m) RDC mandatory
Validations
Code | Description | Resolutions |
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Derivations
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