How to Create a New Clinical Research Study

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1. Create a Submission for an Existing eIRB Study

To create a new clinical research study for a protocol that already exists in eIRB, navigate to the eIRB site and locate the study for which you would like to create a submission.

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4 Please skip ahead to section 4 b.

2. Create a New Submission in eIRB

Starting March 18th, 2013 the Clinical Research Study creation process will start in eIRB. Creating a submission in eIRB will automatically create a Clinical Research Study shell in CRMS. To start this process, navigate to the eIRB site.

To create a new joint CRMS – eIRB submission, click the “New Application” button. a. When the user clicks this button, they will be directed to the IRB Initiation page.

b. This form contains some basic questions required to create a Clinical Research Study in eTRACK. Provide answers to all the applicable questions. Please note – questions with red asterisk (*) are required.

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d. Once all the applicable questions have been answered, scroll down to the bottom of the page and click Continue or Save.

*You do not need to submit your eIRB application for your study to be created in the CRMS.

3. CRMS Clinical Research Study

a. To access the IRB submission from the CRMS Clinical Research Study workspace, click under the Related IRB #.

b. To complete your Clinical Research Study, click the “Edit Clinical Study” button.

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d. The user can access the related IRB submission by clicking the hyperlink in Question 2. (see red box above)

e. Click Continue on the right corner of the SmartForm to go to the next page.

f. Throughout the Clinical Research Study SmartForm, the user will see links to IRB pages under certain questions. To view or update responses, click on these links to go to the IRB submission. (Please remember to click “Create or Update CRMS Study” if updates are made in eIRB)

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h. Answers questions 1-6. Question 1., the CRMS administration must be listed on the eIRB application. The PI and Study Coordinator will automatically be added to this list.

i. Questions 7-12 on page Clinical Research Information are pulled from eIRB.

j. Question 7 on the Clinical Research Information Continue page: Clicking the Add button, will open a new window. Enter the Arm Label, select Arm/Group Type, and Arm Description. The user can add multiple arms by using the “Ok and Add Another” button. Once all arms have been added, click OK

k. Recruitment Information – The information provided on this Smart Form will populate the BeInvolved website. If you do not want your study published on BeInvolved, select “No”.

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4. Uploading a Clinical Trial Agreement

a. The user can upload the Clinical Trial Agreement or Contract and Budget for the Clinical Research Study on the Budget Information page.

b. To upload a contract document, at question 4 and click the “Add” button. Click “Add” at question 5 to upload the sponsor provided budget.

Please note: a contract document and budget are required to submit the Clinical Research Study.

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d. The document uploaded will appear next to the “Browse” button. Click the “OK” button to upload the Clinical Trial Agreement to the CRMS.

e. Once the user clicks the OK button, the page will refresh and the user will be taken to the top of the page. Scroll down to question 4 to verify that the document has been uploaded. The

“Version” field should populate, indicating that the new document has been uploaded. To view this document, click the document hyperlink.

f. Repeat steps c-e for the sponsor provided budget.

g. Complete the remaining Smart Forms and click “Finish” when you have completed all of the forms.

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6. Helpful Tips

 CRMS website https://crms.wakehealth.edu

 eIRB Submission

o You do not need to fully complete your eIRB application in order to begin and submit your study to the CTO through the CRMS

 There are 2 steps to approve the budget. Both steps must be completed for the budget to move to Grants and Contracts Administration.

1. “Agree to Draft Budget” 2. “Record Sponsor Decision

 Exporting Budget and/or Clinical Services Grid

3. Under “Activities” click “Export Budget” and/or “Export Clinical Services” * Excel will not automatically open with the exported file*

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