The code block below illustrates how one might use # and // as comments in your logic and calculations.

This value you provided is not a number. Please try again.

This value you provided is not an integer. Please try again.

The value entered is not a valid Vanderbilt Medical Record Number (i.e. 4- to 9-digit number, excluding leading zeros). Please try again.

The value you provided must be within the suggested range

The value you provided is outside the suggested range

This value is admissible, but you may wish to double check it.

The value entered must be a time value in the following format HH:MM within the range 00:00-23:59 (e.g., 04:32 or 23:19).

This field must be a 5 or 9 digit U.S. ZIP Code (like 94043). Please re-enter it now.

This field must be a 10 digit U.S. phone number (like 415 555 1212). Please re-enter it now.

This field must be a valid email address (like joe@user.com). Please re-enter it now.

The value you provided could not be validated because it does not follow the expected format. Please try again.

Required format:

6ILRA694fT9Y9bxXvaZgns22sfASoGKwi

Trial-CARE Consultation - Request Form

Thank you for requesting a consultation with the Trial-CARE support center.

To better serve you, we request that you provide the information below. This form should take 10 minutes or less to complete. The information provided in this form will be used by the Trial-CARE team to prepare for your consult appointment. If you have questions at any time, please contact Katie Keenoy at keenoyk@wustl.edu.

Thank you!

Please indicate if the person completing this survey is:

Please indicate your name, role, and contact email in the box below

Date Intake Survey completed

How did you learn about Trial-CARE?
(select all that apply)

Referred by a colleague

Referred by the CCS and/or ICTS

ICTS website

Research News or other University announcement

Used services previously

Other (specify)

Please Specify Other

INVESTIGATOR INFORMATION

Specify Other PI Title

Primary Department (or standalone division)

For how long has the PI been conducting clinical research as an independent investigator?

Has the PI served in any of the following roles? (select all that apply)

PI for single center clinical trial

Site PI for externally-sponsored multicenter clinical trial

Overall PI for sponsor-initiated multicenter clinical trial

Overall PI for investigator-initiated multicenter clinical trial

PRIMARY COORDINATOR INFORMATION

Is there a Research Coordinator contact for this study?

Coordinator First Name

Coordinator Last Name

Coordinator E-mail Address

GENERAL STUDY DETAILS

Enter Title of Study

What is the current study status?

Specify Other Study Status

How was this study initiated?

Specify Other Way Study was Initiated

If funded or seeking funding, indicate source (select all that apply)

Not funded/not currently seeking funding

NIH

Foundation

Industry

University/Departmental

Department of Defense (DoD)

PCORI

Other

Specify NIH Funding Source

Specify Foundation Funding Source

Specify Industry Funding Source

Specify University/Departmental Funding Source

Specify Other Funding Source

Is this study single center or multicenter?

If multicenter, will WU be the Clinical Coordinating Center (CCC)?

If multicenter, will WU be the Data Coordinating Center (DCC)?

If multicenter, is study using a single IRB?

If using a single IRB, will WU IRB be serving as the Central IRB?

Does this study involve an Investigational Drug (IND)?

Does this study involve an Investigational Device (IDE)?

STUDY DOCUMENT ATTACHMENTS

Please attach any relevant study materials that you think will help the Trial-CARE team understand the nature/details of the study. Draft versions are ok, and all documents will be kept strictly confidential.

Protocol or Study Synopsis

Specific Aims or Research Strategy

Draft or Completed Contract Agreement

CONSULT AREAS/AVAILABLE RESOURCES

The Trial-CARE team is available to provide guidance on a range of issues related to clinical trials, including guidance on getting funded, rapidly starting a study, and overcoming real-world barriers to trial conduct.

Trial-CARE can provide assistance in developing study organization plans, addressing regulatory issues including IND/IDE guidance, developing budgets, interacting with sponsors, building well-targeted recruitment plans, and connecting investigators with other relevant support services.

In addition, for applicable studies, Trial-CARE offers full trial coordination services in flexible models of partnership with Department-based study teams and investigators.

Below are a few specific areas investigators often have questions about. Please review and select any items you would like to hear more about, or for which you have specific questions to discuss. If there is anything not included in this list, please feel free to add under the "Other" category.

Consult/Service Areas

Biostatistical support

Contracting

Clinical Protocol Development

Data Management

Funding sources/grant development

General MCT Planning

Mobile Health (mHealth - use of technology-based data capture/management tools)

CFR Part 11 Compliance

Recruitment

Regulatory

Safety Monitoring

Site Monitoring/Data Monitoring

Study Budgeting

Study Implementation

Trial-CARE services - general info

Other (specify)

Please check all areas of interest related to Biostatistical Support:

Study Design

Data Analysis

Data Coordination for multicenter trial

Other (specify)

Please specify Other Biostatistical Support:

Please check all areas of interest related to Data Management:

Data Management Plans

Database Development

Other (specify)

Please specify Other Data Management:

Please check all areas of interest related to Regulatory:

FDA (e.g., IND/IDE)

IRB

Clinicaltrials.gov

Electronic informed consent (e-consent)

Other (specify)

Please specify Other Regulatory:

Please check all areas of interest related to Safety Monitoring:

Data Safety Monitoring Boards (DSMBs)

Adverse Event reporting and/or medical monitor/safety officer requirements

Other (specify)

Please specify Other Safety Monitoring:

Please check all areas of interest related to Study Implementation:

CCS Research Coordinator services

CCS Research Project Management services

SOP/MOP Development

Site Monitoring

Other (specify)

Please specify Other Study Implementation:

Please describe what Other Services you would like to review:

Please enter any additional comments or questions you would like to discuss

Please list the names and email addresses of any additional team members or collaborators you would like to include on subsequent consults/meetings

For more information regarding available Trial-CARE services, please contact

Katie Keenoy, MA, at keenoyk@wustl.edu

You have selected an option that triggers this survey to end right now.

To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.