Case Consultations

Date

First Name *

Last Name *

Phone *

Email *

Preferred Method of Contact *

Study Principal Investigator

It is preferred that the study Principal Investigator (PI) complete the Case Consult Form and be present at the Case Consultation.

I understand

I understand, however the PI is unable to fill out this form and/or cannot be present at the case consultation

Department

What type of mHealth research? * What type of mHealth research?

What type of mHealth study structure (check all that apply) *

Single site

Multi-site clinical trial (MCT)

Decentralized clinical trial

Remote/Partially remote clinical trial

What is the source of funding?

NIH

PCORI

Industry

Foundation

Department/University

OtherOther

What are you studying and what is the hypothesis you want to test? *

Do you want to use an existing digital solution in your research? *

Yes

What existing digital solution do you want to use? (please name the product)

Do you want to create a digital solution in your research? *

Yes

Have you established a relationship with a technology vendor?

Yes

Please indicate the technology vendor:

Please categorize the type of digital solution you plan to use or create. *

Smartphone application

Web site

Electronic Data Capture (EDC) system or Content Management System (CMS)

Wearable devices

Database/Server

I am not sure

Other (please specify)Other (please specify)

How will you use the technology platform (check all that apply) *

Active electronic data capture, such as collecting data via surveys/questionnaires

Passive electronic data capture from sensors, wearables, or device metrics

Implement/Supplement an intervention

Medical Devices/Software as a Medical Device

Research dashboard/Graphical User Interface (GUI)

Participant dashboard/Graphical User Interface (GUI)

I am not sure

Other (please specify)Other (please specify)

Additional Project Specifics (Optional)

How may the MHRC help you? (please select a response to find out more)

STUDY PLANNING

STUDY DESIGN + DEVELOPMENT

STUDY DISSEMINATION + IMPLEMENTATION

STUDY OPERATIONS

I’m not sure

OtherOther

What type of STUDY PLANNING can the mHRC help you with?

What type of STUDY DESIGN + DEVELOPMENT can the mHRC help you with?

Protocol, SOP, and/or MOP development

Contracts

IND/IDE Submission

Establishing regulatory compliance (e.g., IRB + HRPO, HIPAA, GDPR, FDA 21 CFR Part 11, ICH, etc.)

Statistical analysis plan

Design and development of data capture

Liaising with 3rd party vendors

I’m not sure

OtherOther

What type of STUDY DISSEMINATION + IMPLEMENTATION can the mHRC help you with?

Study personnel training (e.g., study protocol, MOP, SOP, etc.)

Site initiation visits

Liaising with 3rd party vendor

I’m not sure

OtherOther

What type of STUDY OPERATIONS can the mHRC help you with?

Are you interested in attending or presenting at an MHRC meeting?

Attending

Presenting

N/A

OtherOther

Attachment 2: Request for project/study materials (e.g., AIMS page, research strategy, protocol, consent):

Maximum file size: 51.2MB

Attachment 3: Request for project/study materials (e.g., AIMS page, research strategy, protocol, consent):

Maximum file size: 51.2MB

Attachment 1: Request for project/study materials (e.g., AIMS page, research strategy, protocol, consent):

Maximum file size: 51.2MB

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Case Consultations

Ideas Are Worth Sharing!

📝Case Consult Form

✅Complete this case consultation form to request strategic, technical, regulatory, or scientific feedback from the mHealth Research Core (mHRC).