Illustrates Domains
AE
FA
Illustrates Variables
AESPID
DIPARMCD
AESINTV
AERLDEV
FAORRES
AEACNDEV
Content
Title: Adverse Events - Including Device Event Reporting
| Indicate if the subject experienced any adverse events. If Yes, include the appropriate details where indicated on the CRF. |
Were any adverse events experienced?
AEYN Not submitted
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<From NY codelist> |
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| Record only 1 diagnosis, sign, or symptom per line (e.g., nausea and vomiting should not be recorded in the same entry, but as separate entries). Using accepted medical terminology, enter the diagnosis (if known); otherwise enter a sign or symptom. |
AETERM
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_________________ | |
| Record the start date of the AE using this format (DD-MON-YYYY). |
AESTDAT AESTDTC
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_________________ | |
| If the adverse event has not resolved at the time of data collection, leave the End Date blank. |
Is the adverse event ongoing?
AEONGO AEENRTPT OR AEENRF
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<From NY codelist> |
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| Record the date that the AE resolved using this format (DD-MON-YYYY). If the AE is ongoing, leave the field blank. |
AEENDAT AEENDTC
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_________________ | |
| Assess the severity of the event using the sponsor-defined categories. Severity is not equivalent to seriousness. |
What is the severity of the adverse event?
AESEV
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<From AESEV codelist> |
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| Assess if an adverse event should be classified as serious based on the "serious" criteria defined in the protocol. |
Was the adverse event serious?
AESER
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<From NY codelist> |
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| Record whether the serious adverse event required intervention to prevent permanent impairment or damage due to the use of a medical product. |
Did the adverse event require intervention to prevent permanent impairment or damage resulting from the use of a medical product?
AESINTV NSAE.AESINTV
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<From NY codelist> |
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| Enter the serial identification number for the CGM device. |
CGM_SERIAL_DIVAL Used to find SPDEVID where DI.DIPARMCD = "SERIAL" and DI.DIVAL = CGM_SERIAL_DIVAL
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_________________ | |
| Indicate if the cause of the adverse event is related to the CGM device and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions). |
Was this adverse event related to the CGM device?
CGM_AERLDEV NSAE.AERLDEV
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| If "Related to component(s)" is selected, indicate if the cause of the adverse event is related to the CGM case and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions). |
Was this adverse event related to the CGM case?
CASE_RLDEV_FAORRES FAORRES where FATESTCD = "RLDEV" and SPDEVID matches DI.SPDEVID where DI.DIPARMCD = "DEVTYPE" and DI.DIVAL = "Plastic case, CGM"
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| If "Related to component(s)" is selected, indicate if the cause of the adverse event is related to the CGM cannula and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions). |
Was this adverse event related to the CGM cannula?
CANNULA_RLDEV_FAORRES FAORRES where FATESTCD = "RLDEV" and SPDEVID matches DI.SPDEVID where DI.DIPARMCD = "DEVTYPE" and DI.DIVAL = "CANNULA, CGM"
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| Record the action taken resulting from the adverse event that is related to study CGM device. |
What action was taken with the CGM device?
CGM_AEACNDEV AEACNDEV
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| If "Action taken with component(s)" is selected, record the action taken with the CGM case that resulted from this AE. |
What action was taken with the CGM case as a result of this AE?
CASE_ACNDEV_FAORRES FAORRES where FATESTCD = "ACNDEV" and SPDEVID matches DI.SPDEVID where DI.DIPARMCD = "DEVTYPE" and DI.DIVAL = "Plastic case, CGM"
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| If "Action taken with component(s)" is selected, record the action taken with the CGM cannula that resulted from this AE. |
What action was taken with the CGM cannula as a result of this AE?
CANNULA_ACNDEV_FAORRES FAORRES where FATESTCD = "ACNDEV" and SPDEVID matches DI.SPDEVID where DI.DIPARMCD = "DEVTYPE" and DI.DIVAL = "CANNULA, CGM"
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| Record the appropriate outcome of the event in relation to the subject's status. |
What is the outcome of this adverse event?
AEOUT
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<From OUT codelist> |