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  1. From the Dashboard, click the Create dropdown then the Create Agreement button.

  2. Complete the pages by entering the following information. An answer is not required for every field. Click Continue to move through all the pages. 

Agreement Upload Page

  • 1. Agreement manager/Principal investigator

  • 2. Primary contact

  • 3. Upload agreement draft: Click Upload and upload the Agreement Draft document provided with this course. A Word document is generally preferred, so the Agreements office staff can make changes to it during the review process.

  • 4. Title or internal reference number: Clinical Trial Agreement - <Your Name or Initials>

  • 5. Agreement type: Clinical Trial Agreement

  • 6. Description

  • 7. Supporting documents: Add the Supporting Document PDF file provided with this course.

 General Information Page

On this page, you can enter the data provided or make up your own data. Do not use real data.

  • 1.Contracting party

  • 2. Contracting party contact name

  • 3. Contracting party contact e-mail

  • 4. Contracting party contact phone

  • 5. Responsible department/division/institute: Leave as is

  • 6. Agreement collaborators: Add any person

 Agreement Information Page

  • 1. Phase of study

  • 2. Sponsor protocol number

  • 3. Protocol title

  • 4. Estimated study start date

  • 5. Type of trial

  • 6. Will this study use a contract research organization (CRO)

 Additional Information Page

  • 1. Who developed the protocol

  • 2. Do you expect to make a discovery or invention related to this study

  • 3. Do you expect to make an improvement to the sponsor’s drug

  • 4. Indicate the maximum time

  • 5. Do you or any member of your immediate family

  • 6. Are there any unusual issues with this research study which you feel

Completion Instructions Page

  • Read the instructions on this page.

  1. Click Save.

  2. Click Validate on the left to ensure you did not miss any required fields. If you did, update the required fields.

  3. When done fixing any errors, click Exit on the navigation bar or Finish if on the last page.

The next step is to submit the agreement for review.

  1. Return to the Dashboard.

  2. Confirm you met the success criteria below:

  • The agreement you just created is in My Inbox on the Dashboard.

  • The agreement is in the Pre-Submission state.

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