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:

bhk9o3eE5TSNyRvkVqR5CWeUSXSuox3abZFDGZPDenb8qKSyY3shf2yxqZnQUSFYZrczkBoj2A8zher

Is my study a clinical trial?

The following questions can help you determine if your study is a clinical trial based on the NIH definition of a clinical trial.

If you are not sure how to answer any of these questions with regard to your study you can email (cctrctgov@vcu.edu) the ClinicalTrials.gov administrator. You can also you can find NIH's definition of a clinical trial here.

Does the study involve one or more human participants? Participants can be healthy or have a disease or condition.

Yes No

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Is there a manipulation of the subject or subject's environment (an intervention, a treatment, multiple conditions, exposure to an experience, etc.)?

Examples include:
drugs/small molecules/compounds;
biologics;
devices;
procedures (e.g., surgical techniques);
delivery systems (e.g., telemedicine, face-to-face interviews);
strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits);
treatment strategies;
prevention strategies;
diagnostic strategies

There does not need to be a comparison group.

Yes No

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Is one of your outcomes a change caused by the manipulation/intervention on one or more health-related biomedical or behavioral processes and/or endpoints, either in the person receiving the intervention or in a person who interacts with the person receiving the intervention (for example, if a nurse receives the treatment, is the patient's outcome an endpoint)?

Examples include:
positive or negative changes to physiological or biological parameters (e.g., lung capacity, gene expression, levels of hormones, etc.);
positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood, reading comprehension and /or information retention, craving, etc.);
positive or negative changes to disease processes;
positive or negative changes to health-related behaviors;
positive or negative changes to quality of life

Yes No

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Are ANY of the questions below decided after a person has signed the consent form or based on whether a person has signed the consent form?

- Do they get the treatment/manipulation/intervention?
- How much of the treatment/manipulation/intervention do they get?
- When do they get the treatment/manipulation/intervention?
- Which treatment/manipulation/intervention do they get?

Yes No

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Based on your responses, your study is not a clinical trial. If you feel that this determination is incorrect or have additional question, please contact the Wright Center ClinicalTrials.gov Administrator at cctrctgov@vcu.edu or 804-828-9226.

Feel free to close this browser - it is not necessary to submit your responses.

As a clinical trial, your study should be registered at register.clinicaltrials.gov before you enroll your first participant. Would you like assistance in registering your trial? You can send an email to cctrctgov@vcu.edu or answer the questions below.

Yes No

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If you change your mind regarding assistance with your CT.gov registration, please contact the Wright Center ClinicalTrials.gov Administrator at cctrctgov@vcu.edu.

Feel free to close this browser - it is not necessary to submit your responses.

Your first and last name

* must provide value

Email address

* must provide value

IRB (HM) number if you have it

Study Title

* must provide value

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

Have applied/expect to receive funding for this project

Have received funding for this project

Plan to submit an IND/IDE

Have an IND/IDE

Uses an FDA-regulated Drug

Uses an FDA-regulated Device

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

When do you expect to start enrolling participants?

When do you expect to complete recruitment and enrollment for your study?

What is the funding agency?

* must provide value

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

* must provide value

What is the FDA Center?

* must provide value

What is the IND/IDE number?

* must provide value

What is the IND/IDE Serial number?

* must provide value

Is expanded access available?

Yes

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

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What supporting information will be shared as part of 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

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).

Please provide the name and email address of any other personnel who should have access to the record (can edit the record) - i.e., CRC, department compliance personnel, etc.

Please add any information about your study you feel would be helpful.

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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.