GU-PASS Clinical Trial Module

Study Coordinators     PI - Principal investigators     Department HeadS

New Clinical Trial Contracts fOR STUDY COORDINATORS

Go to: https://gu-pass.georgetown.edu and login with your NetID and NetID password.
Click on the New Clinical Trial Contract box.

New Clinical Trial Contract

You will be lead to the Clinical Trial Contract - Submission Information section. Choose your Principal Investigator from the pull-down menu.
If you do not see the specific Investigator you need, write to GU-PASS (gu-pass@georgetown.edu), Eve Sakran (es1310@georgetown.edu) or Doreen Robinson
(Doreen.Robinson@georgetown.edu)

Submission Form

Choose the Department and the Study Coordinator's information. This is where your information (email address, physical address and department)
should be listed. 
Study Coordinator Box

There may be times that the Study Coordinator needs to list other Georgetown University or Georgetown University Hospital Invetigators. 
If you see their name, click on ADD.

GU or GUY Investigators

Choose the additional Investigator and add them, by choosing SELECT.

Select PI

Upload the Confidentiality Disclosure Agreement (one should be available from your computer). Attach the completed form to properly add to this submission.

Confidentiality Agreement

Once you have attached the proper document, you will see it listed below.

Disclosure Agreement

Identify the Phase, whether this is a 'zero dollar' trial, if the intellectual property is involved, and particulars about the design.

Phase Information

The section following is for Sponsor Information. Specify the Sponsor Type, Name, CRO, and Contact Information.

Sponsor Information

Transmittal Data is the section that identifies where the study will take place. Answering the questions that follow may require
additional information. If you were to say 'yes' to the project involving additional sites, another box would appear for you to 
identify those sites
.

Transmittal Data

There are 3 required attachments for this application to move to the next approval. The first is the Initial Budget offered from
Sponsor. Attach the document below.  

Initial Budget Offered

If there are additional documents that need to be attached, please attach them below. 

Attach Budget Documents

If you have forms available, upload them. In addition, the IRB Protocol numbers should be listed, along with the submitted
and approval date. There are calendars at the end of the IRB submitted/approved dates to assist you with the dates you are 
adding.

ICF

There are additional forms that should be uploaded. Please pay attention to the required documents that must be properly uploaded. 
They are (1) The Initial Budget Offered from Sponsor, (2) The Contract Document, and (3) the Protocol Document.

IRB Approval Letter

When you save the contract, you will see the formal number (ID) as well as the status. This example has an ID of 16206.

 Status

Now that you have the information necessary, click to Submit for PI Review.

Submit

You will be prompted to confirm. Choose to proceed. 

Confirmation

The document has been moved to the PI's queue. If the PI has concerns about the contract, they can submit the information back to you. 
Login with your NetID and NetID password, and you will see within the status that there are changes that need to be made. Click on 
View/Edit/Act in the upper-left corner. 

Review

You will see the notes from the PI listed below. 

PI Notes

Resubmit your contract. 

Re-Submit

Confirm and Proceed

Proceed

With the changes made, this moves back to the PI for another approval. In addition, there may be situations when the Department Chair
will send a contract for your review.  You will receive a contract with an explanation of the changes that need to be made. Click to 
add comments, and make the necessary changes. Finally, Re-Submit.

 Review Notes

The notes have been placed for the Department Head to see. Re-submit and confirm.

NEW CLINICAL TRIAL CONTRACTS FOR PI - Principal Investigators

The PI should receive an email explaining that there is a contract that has been placed in your queue, and we are waiting for you to review it.  Go to: https://gu-pass.georgetown.edu and login with your University NetID
and NetID password.   Click on the View/Edit/Act button to move to the next steps in Contract Review.

PI Review

You will be prompted to review the information, and click Yes or No.

PI_2

If you were to choose 'no', you would need to add information to explain to the Study Coordinator what needs to be added or changed. Click on New.

No answer

A box to add your notes will open. Please provide any information to assist the Study Coordinator with their documentation. Click on save when your notes are complete.

PI Notes

As soon as you complete your notes, click to send them back to the Submitter. 

General Form Actions

Confirm that this is your intention. Click on Proceed. 

Confirmation

You will receive an email once the requested changes have been made. This is to inform you that the contract is back in your queue.  Login. You will notice 
that your status says 'PI Review'.  Click on View/Edit/Act in the upper-left corner.

Review 2

Upon review, all of the information should be correct. Choose "yes" to approve the contract.  On the right side, choose to Submit for Department Review. 

Department Review

Choose to Proceed.

Proceed

The contract moves on to the Department Head. The Department Head will receive an email prompting them that a contract is awaiting their approval. 

NEW CLINICAL TRIAL CONTRACTS FOR Department headS

 The Department Head should receive an email explaining that there is a contract that has been placed in your queue. Please review and approve. Go to https://gu-pass.georgetown.edu and login with your NetID and NetID password.
Click on the items within your review queue. You will notice that the status of the item below is "Department Review". Click on the View/Edit/Act button to move to the next steps.

Dept Review

You will be prompted to review the information, and click Yes or No. If you choose to send it back, click on No. You can add comments to the button below, then Send Back to Submitter on the right side.

Dept Review 2

Once you have added the notes that will be sent back to the PI, choose to Send Back to the Sumitter, and click on Proceed.

Confirmation

Once the Study Coordinator has made  the necessary changes, the Department Head will receive another email message. Log back into GU-PASS. The status will say 
up for Department Review (right side).

Dept Review 4

Upon review, the Department Head is ready to approve.  Choose Yes and Submit Department Chair Review (right side).

Department Chair 7

Confirm and Proceed.

Confirm.