Adverse Events (AE) with Device Event Reporting

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

<From NY codelist>

AESPID Hidden/pre-populated
Sponsor-defined
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
_________________
Record the start date of the AE using this format (DD-MON-YYYY).
AESTDAT AESTDTC
_________________
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

<From NY codelist>

Record the date that the AE resolved using this format (DD-MON-YYYY). If the AE is ongoing, leave the field blank.
AEENDAT AEENDTC
_________________
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

<From AESEV codelist>

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

<From NY codelist>

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

<From NY codelist>

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
_________________
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
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"
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"
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
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"
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"
Record the appropriate outcome of the event in relation to the subject's status. What is the outcome of this adverse event?
AEOUT

<From OUT codelist>

View CRF Metadata
Order NumberTAUG ReferenceCDASHIG VariableQuestion TextPromptData TypeCase Report Form Completion InstructionsSDTMIG TargetSDTM Variable MappingControlled Terminology Codelist NameCRF Implementation NotesPermissible ValuesPre-populated ValueQuery DisplayList StyleHidden
1TAUG-T1D-P&DAEYNWere any adverse events experienced?Any Adverse EventstextIndicate if the subject experienced any adverse events. If Yes, include the appropriate details where indicated on the CRF.

(NY)
Yes; No

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2TAUG-T1D-P&DAESPIDWhat is the adverse event identifier?Line Numbertext



AESPID
N/AIn this example, each record is assigned a unique identifier. If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.
Sponsor-defined

Y
3TAUG-T1D-P&DAETERMWhat is the adverse event term?Adverse EventtextRecord 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
N/A





4TAUG-T1D-P&DAESTDATWhat is the adverse event start date?Start DatetextRecord the start date of the AE using this format (DD-MON-YYYY).AESTDTC
N/AN/A




5TAUG-T1D-P&DAEONGOIs the adverse event ongoing?OngoingtextIf the adverse event has not resolved at the time of data collection, leave the End Date blank.AEENRTPT; AEENRFAEENRTPT OR AEENRF(NY)
Yes; No

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6TAUG-T1D-P&DAEENDATWhat was the adverse event end date?End DatetextRecord the date that the AE resolved using this format (DD-MON-YYYY). If the AE is ongoing, leave the field blank.AEENDTC
N/A





7TAUG-T1D-P&DAESEVWhat is the severity of the adverse event?SeveritytextAssess the severity of the event using the sponsor-defined categories. Severity is not equivalent to seriousness.AESEV
(AESEV)
Mild; Moderate; Severe

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8TAUG-T1D-P&DAESERWas the adverse event serious?SerioustextAssess if an adverse event should be classified as serious based on the "serious" criteria defined in the protocol.AESER
(NY)
Yes; No

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9TAUG-T1D-P&DAESINTVDid the adverse event require intervention to prevent permanent impairment or damage resulting from the use of a medical product?Needs Intervention to Prevent ImpairmenttextRecord whether the serious adverse event required intervention to prevent permanent impairment or damage due to the use of a medical product.

NSAE.AESINTV


(NY)
Yes; No

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10TAUG-T1D-P&DCGM_SERIAL_DIVALWhat is the serial number for the continuous glucose monitoring (CGM) device?CGM Serial NumbertextEnter the serial identification number for the CGM device.

DI.DIVAL

Used to find SPDEVID where DI.DIPARMCD = "SERIAL" and DI.DIVAL = CGM_SERIAL_DIVALN/A





11TAUG-T1D-P&DCGM_AERLDEVWas this adverse event related to the CGM device?Relationship to CGM DevicetextIndicate 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).NSAE.AERLDEVNSAE.AERLDEVN/A"Related to component(s)" is a placeholder value that maps to "MULTIPLE"NOT RELATED; UNLIKELY RELATED; POSSIBLY RELATED; PROBABLY RELATED; RELATED; Related to component(s)

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12TAUG-T1D-P&DCASE_RLDEV_FAORRESWas this adverse event related to the CGM case?Relationship to CGM Case ComponenttextIf "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).FAORRESFAORRES where FATESTCD = "RLDEV" and SPDEVID matches DI.SPDEVID where DI.DIPARMCD = "DEVTYPE" and DI.DIVAL = "Plastic case, CGM"N/A
NOT RELATED; UNLIKELY RELATED; POSSIBLY RELATED; PROBABLY RELATED; RELATED

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13TAUG-T1D-P&DCANNULA_RLDEV_FAORRESWas this adverse event related to the CGM cannula?Relationship to CGM Cannula ComponenttextIf "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).FAORRESFAORRES where FATESTCD = "RLDEV" and SPDEVID matches DI.SPDEVID where DI.DIPARMCD = "DEVTYPE" and DI.DIVAL = "CANNULA, CGM"N/A
NOT RELATED; UNLIKELY RELATED; POSSIBLY RELATED; PROBABLY RELATED; RELATED

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14TAUG-T1D-P&DCGM_AEACNDEVWhat action was taken with the CGM device?Action Taken with CGM Device Due to AEtextRecord the action taken resulting from the adverse event that is related to study CGM device.AEACNDEVAEACNDEVN/ASponsor-controlled Terminology. Actions that are related to the device (e.g., Device Removed, Primary Care Physician Notified). See the SDTM Device IG for information on reporting multiple actions, or actions with multiple devices. "Action taken with component(s)" is a placeholder value that maps to "MULTIPLE"None; Removed; Device replaced; Action taken with component(s)

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15TAUG-T1D-P&DCASE_ACNDEV_FAORRESWhat action was taken with the CGM case as a result of this AE?Action Taken with CGM Case Component Due to AEtextIf "Action taken with component(s)" is selected, record the action taken with the CGM case that resulted from this AE.FAORRESFAORRES where FATESTCD = "ACNDEV" and SPDEVID matches DI.SPDEVID where DI.DIPARMCD = "DEVTYPE" and DI.DIVAL = "Plastic case, CGM"N/ASponsor-controlled Terminology. Actions that are related to the device (e.g., Device Removed, Primary Care Physician Notified). See the SDTM Device IG for information on reporting multiple actions, or actions with multiple devices.None; Device replaced

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16TAUG-T1D-P&DCANNULA_ACNDEV_FAORRESWhat action was taken with the CGM cannula as a result of this AE?Action Taken with CGM Cannula Component Due to AEtextIf "Action taken with component(s)" is selected, record the action taken with the CGM cannula that resulted from this AE.FAORRESFAORRES where FATESTCD = "ACNDEV" and SPDEVID matches DI.SPDEVID where DI.DIPARMCD = "DEVTYPE" and DI.DIVAL = "CANNULA, CGM"N/ASponsor-controlled Terminology. Actions that are related to the device (e.g., Device Removed, Primary Care Physician Notified). See the SDTM Device IG for information on reporting multiple actions, or actions with multiple devices.None; Cannula repositioned; Device replaced

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17TAUG-T1D-P&DAEOUTWhat is the outcome of this adverse event?OutcometextRecord the appropriate outcome of the event in relation to the subject's status.AEOUT
(OUT)
FATAL; NOT RECOVERED/NOT RESOLVED; RECOVERED/RESOLVED; RECOVERED/RESOLVED WITH SEQUELAE; RECOVERING/RESOLVING; UNKNOWN

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