CDE Detailed Report

Disease: content
Sub-Domain: Devices
CRF: welcome

Displaying 1 - 21 of 21
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C14517 Device manufacturer name DevManufName The company responsible for development of the device The name of the manufacturer of the device that was placed in the subject's body Device Manufacturer Alphanumeric

Record the device manufacturer. Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data 255

Free-Form Entry

C18558 Device implanted other adverse effect modification description text DevImpOthAEModDescTxt The reason for modification of original parameters or original electrode configuration of implanted device due to other Adverse Event (AE), specification The reason for modification of original parameters or original electrode configuration of implanted device due to other Adverse Event (AE), specification Other Adverse Event, specify Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Devices Log Devices Treatment/Intervention Data 255

Free-Form Entry

C14518 Device component type DevCompTyp The name of a part of the device that has a registration number or serial number The name of a part of the device that has a registration number or serial number Device Component Registration number or Serial number INS;Lead;Extension Implanted Nerve Stimulator (INS);Lead;Extension Alphanumeric

Select the component(s) of the device as applicable. Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C18559 Device implanted serious adverse effect modification description text DevImpSAEModDescrTxt The reason for modification of original parameters or original electrode configuration of implanted device due to serious device adverse effect(s) specification The reason for modification of original parameters or original electrode configuration of implanted device due to serious device adverse effect(s) specification Serious Adverse Device Effect(s), specify Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Devices Log Devices Treatment/Intervention Data 255

Free-Form Entry

C14519 Device component registration or serial number DevCompRegstrnSerialNum The registration number or serial number of the device and component(s) to distinguish it from other devices (extension if applicable) The registration number or serial number of a part of the device Device Component Registration number or Serial number Numeric Values

Enter all applicable device registration or serial number(s). Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data

Free-Form Entry

C18564 Device log line number DevLogLineNum The referenced line number of the entry on the device log. The referenced line number of the entry on the device log. Line number Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Devices Log Devices Treatment/Intervention Data

Free-Form Entry

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C14520 Device stimulation target anatomic site DevStimTargAntmicSite The target of stimulation the device acts upon (where the device lead is located) The part of the body the device is stimulating Stimulation Target Left Vagus Nerve;Hippocampus;Hippocampus: Left side;Hippocampus: Right side;AN;AN: Unilateral;AN: Bilateral;Other, specify Left Vagus Nerve;Hippocampus;Hippocampus: Left side;Hippocampus: Right side;AN;AN: Unilateral;AN: Bilateral;Other, specify Alphanumeric

Indicate stimulation target of device. Choose only one. Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 1.00 2012-10-05 00:00:00.0 Devices Log Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C18955 Device implanted other text DevImpOTH The free-text field related to 'Device implanted type' specifying other text. The type of device used The free-text field related to 'Device implanted type' specifying other text. The type of device used Other, specify Alphanumeric

Record the type of device. Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data 4000

Free-Form Entry

C14521 Device lead type DevLeadTyp Type of insulated wires (leads) for the device implanted Type of insulated wires (leads) Type of Lead VNS;Depth;Strip;Other, specify VNS (Vagus Nerve Stimulation);Depth;Strip;Other, specify Alphanumeric

Choose all that apply; if other specify. Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C18956 Device stimulation target anatomic other text DevStimTargAntmicOTH The free-text field related to 'Device stimulation target anatomic site' specifying other text. The target of stimulation the device acts upon (where the device lead is located) The free-text field related to 'Device stimulation target anatomic site' specifying other text. The target of stimulation the device acts upon (where the device lead is located) Other, specify Alphanumeric

Indicate stimulation target of device. Choose only one. Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 1.00 2012-10-05 00:00:00.0 Devices Log Devices Treatment/Intervention Data 4000

Free-Form Entry

C14522 Device lead contact count DevLeadContctCt The number of contacts of the insulated wires (leads) The number of contacts of the insulated wires (leads) Number of Contacts Numeric Values

Indicate number of contacts for lead, if applicable. Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data

Free-Form Entry

C18957 Device lead other text DevLeadOTH The free-text field related to 'Device lead type' specifying other text. Type of insulated wires (leads) for the device implanted The free-text field related to 'Device lead type' specifying other text. Type of insulated wires (leads) for the device implanted Type of Lead Alphanumeric

Choose all that apply; if other specify. Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data 4000

Free-Form Entry

C14523 Device neurostimulator anatomic site DevNeurostimAntmicSite The location in the body of where the device is providing electrical stimulation The location in the body of where the device is providing electrical stimulation Location of Neurostimulator Right chest;Left chest;Other, specify Right chest;Left chest;Other, specify Alphanumeric

Choose all that apply; if other specify. Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C18958 Device neurostimulator anatomic other text DevNeurostimAntmicOTH The free-text field related to 'Device neurostimulator anatomic site' specifying other text. The location in the body of where the device is providing electrical stimulation The free-text field related to 'Device neurostimulator anatomic site' specifying other text. The location in the body of where the device is providing electrical stimulation Other, specify Alphanumeric

Choose all that apply; if other specify. Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data 4000

Free-Form Entry

C14524 Device permanent explant date DevPermExplantDate Date the device was removed from the subject Date the device was removed from the subject Date of Permanent Explant Date or Date & Time

As applicable, complete the Implanted Devices Log if (device) not explanted. Core for all prospective intervention studies. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data

Free-Form Entry

C18959 Device discontinuation other text DevDisctOTH The free-text field related to 'Device discontinuation reason' specifying other text. The reason the subject discontinued use of the device The free-text field related to 'Device discontinuation reason' specifying other text. The reason the subject discontinued use of the device Other, specify Alphanumeric

Indicate reason for discontinuation, if applicable Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data 4000

Free-Form Entry

C14525 Device part left in the body indicator DevPartLftInBodyInd An indicator of whether any part of the device was left in the subject's body after the device was removed, with identification of the part An indicator of whether any part of the device was left in the subject's body after the device was removed and identification of the part Is any part of the device left in the body? No;Yes No;Yes Alphanumeric

Indicate if any part of device is remaining in body after therapy. Record in the log along with the location of the part. Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C14515 Device implanted type DevImpTyp The type of device used The type of device used Device Name VNS;DBS;RNS;Other, specify VNS (Vagus Nerve Stimulation);DBS (Deep Brain Stimulation);RNS (Responsive Neurostimulation System);Other, specify Alphanumeric

Record the type of device. Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C14527 Device discontinuation reason DevDisctRsn The reason the subject discontinued use of the device The reason use of the device was discontinued If applicable, Reason for Discontinuation Serious device adverse effect(s), specify;Intolerable stimulation related adverse event, specify;Other adverse event, specify;Inadequate Seizure Control;Other, specify Serious device adverse effect(s), specify;Intolerable stimulation related adverse event, specify;Other adverse event, specify;Inadequate Seizure Control;Other, specify Alphanumeric

Indicate reason for discontinuation, if applicable Core for all prospective intervention studies

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C14516 Device implanted implant date and time DevImpImplantDateTime Date (and time, if applicable and known) the device was implanted and became functional. The date the device was functional and implanted for the first time. Date of Initial Implant Date or Date & Time

Record the date of initial implant. Core for all prospective intervention studies. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Devices Log Devices Treatment/Intervention Data

Free-Form Entry

C18556 Device implanted intolerable stimulation adverse effect modification description text DevImpIntoleStimAEModDescTxt The reason for modification of original parameters or original electrode configuration of implanted device due to intolerable stimulation related Adverse Event (AE), specification The reason for modification of original parameters or original electrode configuration of implanted device due to intolerable stimulation related Adverse Event (AE), specification Intolerable Stimulation Related Adverse Event, specify Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Devices Log Devices Treatment/Intervention Data 255

Free-Form Entry

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