DCT Protocol Requirement Checklist

Q1:Name

Q2:DCT Studies PlanningQ1-1: Are there any upcoming protocols that include DCT designs?

Q3:Q1-2: Which modules of the DCTs are expected in those protocols (e.g. eConsent, Televisit, ePRO/eDiary, Wearable Device, Remote Monitoring…etc.)

Q4:Q2-1: What is the expected timeframe for those studies to be initiated?

Q5:Q2-2: Which countries do those protocols plan to include?

Q6:TelevisitQ1: What are the protocol requirements expected for Televisit other than those listed below?

Q7:Q2: Would you expect to use Televisit as standalone module in the study protocol or would you require Televisit coupled with ePRO/eDiary

Q8:Electronic Clinical Outcome Assessment (eCOA)Q1-1: Does the protocol contain eCOA?

Q9:Q1-2 Which of the following eCOA is expected in the protocol?

Q10:Q2: Of the eCOA planned to be used in the upcoming protocol, what is the preference of the eCOA device?

Q11:Q3: Which data formats are expected for eCOA data export?

Q12:Q4: Do your study protocols generally use licensed ePROs or publicly available ePROs? Please help to list down those commonly used ePROs in your study protocols.

Q13:Q5: For license required ePROs, what is your expectation on scope of service from Aurora in obtaining authorization from the author?

Q14:eConsentQ1-1: Would your study procedure include eConsent?

Q15:Q1-2: If yes, what are the features required other than those described below according to study requirement and local regulations?

Q16:Q2: If your study procedure require eConsent, do you foresee the need to involve additional roles to support the eConsent process for the subject? E.g. Parents, caregivers…etc.

Q17:Sensor and DeviceQ1-1: Do you require sensors and devices to be used in your current or upcoming protocols?

Q18:Q1-2 If yes, what are the features and support needed other than those described below?

Q19:Q2: Which type of devices/sensors are planned to be used in those protocols? Please help to provide the name of the devices/sensors, brand model.

Q20:Q3: Would you require Aurora to provide support on sourcing of those devices/sensors? If yes, what is the scope of services you would like Aurora to fully cover?

Q21:Remote MonitoringQ1: Do you use remote monitoring in your current studies? If yes, any features of the system used which you felt would need improvements or would require to be included yet not in place?

Q22:Q2: Would you require Aurora CTMS to be part of the remote monitoring solution platform? Or preference is to use your current CTMS service provide and include Aurora remote monitoring as a separate module?

Q23:Q3: In addition to remote collaboration between site personnel monitors via video technology feature of Aurora’s remote monitoring portal, would you expect the system to remotely access site’s HIS (Hospital Information System)?