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

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dVMFYCNYCo8APb6QP7KLtYSJZyPXhYRRkcJN5epSdWYZPnh8LA4Z85Z4HuBL5q2u3XTDoaniAgJF5eGEz3z7AwBBGj8urUdjhF5aoBCwDADx

ClinicalTrials.gov account request form

The VCU Clinical Trials.gov Administrator is responsible for creating user accounts for investigators to access the VCU organizational account in the ClinicalTrials.gov (CT.gov) protocol registration system (PRS). The PRS system is used to register and update investigator-initiated clinical trials conducted at VCU. By completing the following form, the principal investigator (PI) or their designee can initiate this process. The PI remains ultimately responsible for ensuring that their clinical trials are registered on clinicaltrials.gov in accordance with the VCU compliance notice (Compliance Notice 17-003).

By clicking “Submit”, the information provided will be used by the VCU ClinicalTrials.gov Administrator to create a CT.gov PRS user account. The requester will receive an email from register.clinicaltrials.gov with a user name, password, and instructions on how to access the account. If you do not receive that email within 2 working days of submitting your request, please contact the CT.gov Administrator at cctrctgov@vcu.edu. If you have requested assistance in creating your new record, need to be added to an existing record, or need to transfer existing records to VCU the CT.gov Administrator will follow up with further information.

If you have additional questions, please contact the ct.gov administrator at cctrctgov@vcu.edu.

First name

* must provide value

Last name

* must provide value

VCU email address

* must provide value

Phone number

* must provide value

Department/Division (start typing your department/division name - it is does not appear in the dropdown list enter "other)

* must provide value

Other department

I need a ClinicalTrials.gov registration system account to (select all that apply)

* must provide value

be added to existing studies

transfer a study to VCU

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, study manager, or other study support

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

* must provide value

Would you like the assistance in registering the study?

* must provide value

I would like assistance in creating my record

I would like to learn how to create a record in CT.gov

I, or my staff, will create my record

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What is the IRB (HM) number?

Study Title

* must provide value

If you should not be listed as a the central contact person, please provide the name, email address, and phone number of the central contact person for the study.

Expand

Please provide the name, email address, and phone number of a backup contact person for the study.

Expand

Please provide the name and email address of any other personnel who should have edit or review access to the record (for example, a CRC who is responsible for compliance for the project).

Expand

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

Expect to receive funding for this project

Have received funding for this project

FDA-regulated Drug

FDA-regulated Device

Plan to submit an IND/IDE

Have an IND/IDE

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 (not VCU's FP number - the number from the funding agency)?

What is the FDA Center?

IND/IDE Number

IND/IDE Serial Number

Is expanded access available?

Yes

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When do you expect to start enrolling participants? If you are not sure, an estimate is fine (month/year).

* must provide value

When do you expect to complete recruitment and close enrollment for your study (even if you will still be collecting data)? If you are not sure, an estimate is fine (month/year).

* must provide value

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).

Upload file

Which of these best describes your role on the studies to which you need to be added? (check all that apply)

* must provide value

I am the IRB PI of record

I am a Co-PI/Co-I

I am the coordinator or other study support

What is/are the IRB (HM) number(s) of the record(s) on which you are the IRB PI of record?

* must provide value

What is/are the IRB (HM) number(s) of the record(s) on which you are the IRB Co-PI/Co-I?

* must provide value

What is/are the IRB (HM) number(s) of the record(s) on which you are the study coordinator/study staff?

* must provide value

Which of these best describes your role on the studies to be transferred? (check all that apply)

* 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

What institution currently holds the record(s)?

* must provide value

Name of the contact person at ______

* must provide value

Email of the contact person at ______

* must provide value

What is/are the NCT number(s) of the record(s) to be transferred on which you are the IRB PI of record?

* must provide value

What is/are the NCT number(s) of the record(s) to be transferred on which you are the Co-PI/Co-I?

* must provide value

Who is the VCU IRB PI of record (last name, first initial)? If there are different PIs for different NCT numbers, please list the PIs in the same order that the NCT numbers are listed.

* must provide value

What is/are the NCT number(s) of the record(s) to be transferred which are your training project(s)?

* must provide value

Who is the VCU IRB PI of record (last name, first initial)? If there are different PIs for different NCT numbers, please list the PIs in the same order that the NCT numbers are listed.

* must provide value

What is/are the NCT number(s) of the record(s) to be transferred on which you are the coordinator or other support staff?

* must provide value

Who is the VCU IRB PI of record (last name, first initial)? If there are different PIs for different NCT numbers, please list the PIs in the same order that the NCT numbers are listed.

* must provide value

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