DIA-CSRC Mobile Tech Survey

Remote Cardiac Monitoring Survey

This survey will be used to identify present knowledge level and experience with remote cardiac monitoring to inform content of the DIA-CSRC think tank entitled, “CSRC/DIA Think Tank: Evaluation of Mobile Technologies in CV Medicine.”

Question Title

* 1. Are presently working for a/an:

Biopharmaceutical company

CRO

Academic/consulting

Regulatory agency

Question Title

* 2. What is your primary role? (Check all that apply)

Clinical Researcher

Research Scientist/R&D

Clinical Operations Manager (manager, site coordinator, etc)

Medical/Scientific Affairs

Regulatory

Outsourcing

Question Title

* 3. Which of the following modalities have you or your organization implemented in a clinical trial in a remote/ambulatory setting?

Cardiac ECG monitoring

Glucose monitoring

Blood pressure monitoring

Other (please specify)

Question Title

* 4. Please indicate your level of familiarity with the indications, capabilities and limitations of the following cardiac monitoring device types: (Scale 1-4 --with 1 = no familiarity and 4= significant familiarity)

	1	2	3	4
Standard Holter Monitor	Standard Holter Monitor 1	Standard Holter Monitor 2	Standard Holter Monitor 3	Standard Holter Monitor 4
Extended Holter Monitor	Extended Holter Monitor 1	Extended Holter Monitor 2	Extended Holter Monitor 3	Extended Holter Monitor 4
Standard Event Recorder	Standard Event Recorder 1	Standard Event Recorder 2	Standard Event Recorder 3	Standard Event Recorder 4
Autotrigger Event Recorder	Autotrigger Event Recorder 1	Autotrigger Event Recorder 2	Autotrigger Event Recorder 3	Autotrigger Event Recorder 4
Wireless Event Recorder	Wireless Event Recorder 1	Wireless Event Recorder 2	Wireless Event Recorder 3	Wireless Event Recorder 4
Mobile Cardiac Telemetry	Mobile Cardiac Telemetry 1	Mobile Cardiac Telemetry 2	Mobile Cardiac Telemetry 3	Mobile Cardiac Telemetry 4
Implantable Loop Recorder	Implantable Loop Recorder 1	Implantable Loop Recorder 2	Implantable Loop Recorder 3	Implantable Loop Recorder 4
Phone App Monitor	Phone App Monitor 1	Phone App Monitor 2	Phone App Monitor 3	Phone App Monitor 4

Question Title

* 5. Who chooses the type of device that will be used for a study in your organization?

Myself

Study coordinator

Consultation with key opinion leader

Consultation with monitoring device manufacturer

Question Title

* 6. Who evaluates the cardiac monitoring data generated by a study done by your organization?

Myself

Core lab cardiologists

Independent cardiologists

Monitoring center technician

Question Title

* 7. Has your organization implemented outpatient continuous ECG monitoring or other remote monitoring in a clinical trial?

Yes

No

Question Title

* 8. If you responded yes to question seven, what clinical phase and indication was it included for?

Question Title

* 9. Do you see your organization implementing outpatient extended continuous monitoring in a clinical trial in the next 1-2 years?

Question Title

* 10. Outpatient continuous ECG monitoring is most likely to be implemented in a clinical trial for:

Safety endpoint

Efficacy endpoint

Both Safety and Efficacy