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:

6ronHYaGr8SPoe5QYM8u7TZroSGHmmcIghw7uVyb79m7iKnr6Pnj3PngwD5TrmxdXdhobBD7FvDd7YEVgTaWj5tA7INvdzEmKs

ClinicalTrials.gov record assistance request form

The ClinicalTrials.gov Administrator will be happy to help you create your CT.gov record. Please answer the following questions and the CT.gov Administrator will be in touch with you soon.

First name

* must provide value

Last name

* must provide value

VCU or VCU Health email address

* must provide value

Phone number

* must provide value

Department/Division

* must provide value

Other department

Which of these best describes your role on the new study to be registered?

* must provide value

I am the IRB PI of record

I am a Co-PI/Co-I

This is my grad school/post doc/residency/fellowship project

I am the coordinator or other study support

reset

Who is the VCU IRB PI of record (last name, first initial)?

* must provide value

What is the IRB (HM) number?

* must provide value

Study Title

* must provide value

Please check all of the following that apply for this study.

Expect to receive funding for this project

Have received funding for this project

Plan to submit an IND/IDE

Have an IND/IDE

FDA-regulated Drug

FDA-regulated Device

Have a plan to make individual participant data (IPD) available to other researchers

What is the funding agency?

What is the grant or award number? If you do not know the grant or award number, what is VCU's FP number?

When do you expect your study start date to be? If you are not sure, an estimate is fine (month/year).

Study start date: The actual date on which the first participant was enrolled in a clinical study.

* must provide value

When do you estimate the primary completion date for the study to be? If you are not sure, an estimate is fine (month/year).

Primary completion date: The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures.

* must provide value

When do you estimate the study completion date for the study to be? If you are not sure, an estimate is fine (month/year).

Study completion date: The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit).

* must provide value

What is the FDA Center?

IND/IDE Number

Is expanded access available?

Yes

reset

Please provide the following information about your IPD Sharing Plan:
Plan description
Time frame
Access criteria
URL (if any)

* must provide value

Expand

What supporting information will be shared with the IDP?

Study protocol

Statistical Analysis Plan (SAP)

Informed Consent Form (ICF)

Clinical Study Report (CSR)

Analytic Code

Please provide the name, email address, and phone number of the central contact person for the study (note that this information is part of the public CT.gov record).

* must provide value

Expand

Please provide the name, email address, and phone number of the backup contact person for the study (note that this information is part of the public CT.gov record).

Expand

Please provide the name, and email address of any other personnel who should have access to the record (can edit the record).

Expand

Please upload a copy of the consent form (it can be a draft and does not need to have been approved - this is just to assist the administrator in creating a draft record for you).

Upload file

Please upload a copy of the protocol (it can be a draft and does not need to have been approved - this is just to assist the administrator in creating a draft record for you).

* must provide value

Upload file

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.