How to Create and Submit a Protocol in eCompliance – PI

Submitting a new Protocol involves five (5) basic functions:

1. Create the Protocol Record.
2. Add Protocol Personnel.
3. Complete the Application Forms.
4. Upload Required Files.
5. Electronic Signatures.

Create the Protocol Record

Log in to the system and select IRB from the menu (if needed).

Click the My Protocols option (left side menu).

Click the Create New Protocol option (top of main screen).

Remember: In some instances of eCompliance, clicking the Create New Protocol button will initiate a pre-protocol survey. This survey is designed to assist the PI in determining the proper level of review (exempt, expedited, full board). Other instances do not use this survey, and you will be taken directly to the protocol submission form.

If you are a student, eCompliance will prompt you to identify your faculty advisor.

Enter the Last Name of your Advisor in the field and click to select their name from the list that displays.

Click the Continue button.

The Create New Protocol form displays.

The contents of the Protocol Submission Form will vary depending on the configuration for your instance of this system.

In general, the figure below shows fields (name may be same or similar) that will likely display.

Populate required* and optional fields to complete the Protocol Submission Form.

*Fields that display a star are required.

Remember: you can Edit your Protocol after you initially Save it.

Based on your Institution’s setup, after selecting the Review Level options, additional fields may need to be populated; these may include exemption or expedited review categories as well as custom defined questions by your institution.

In most cases, you will not be prompted to upload any files on the Create New Protocol form.

You can include additional files after saving your Protocol by using the Upload button (top of the View Protocol screen).

You may be prompted to upload files in the Application forms that are linked to your Protocol after the record is created (saved).

Notice the Submit Protocol for Review button; you must click this button to formally add it to the IRB.

Your protocol is visible to the IRB, the Chair, and the Administrator in addition to your Faculty Advisor (if you are required to name one), so if you have questions and would like them to look at it before you formally submit, they will be able to see the record and any uploaded files.

Adding Personnel to Your Protocol

• Click on the Personnel section on the View Protocol page and then click on the Add/Edit Personnel button.
• The form displays options allowing you to add Co-investigators and Research Staff.
• Type the Last Name (or First, if you believe it to be less common) into the text field and Select the User from the List.
  • The name MUST BE SELECTED from the list; entering text in the fields will not allow completion of the entry.

After selecting the name, click the Add button.

The name displays below the field. You can continue to add names as needed.

If you select the wrong name, click the “x” to the left of the name and the name will be removed.

Complete the Application Forms

Click on the Application Forms section on the View Protocol page.

A new page opens listing the Forms that must be completed before submitting your protocol.

The red indicator shows the number of questions that are required to have answers in each form.

Click the Form Title to expand the display of the selected Form and this system will display questions (examples shown below).

Click the Answer button and Answer the Questions in the popup form.

On Save of your answers the system will automatically open the next set of questions in that Form.

You can close out of the Forms screen at any time and return at a later time or date to complete the forms.

Upload Files to Your Protocol

Files may be uploaded directly to Application Form Questions that request a file upload.

Files may also be uploaded on the View Protocol screen under the Files section.

Click the Upload Docs button in the Files section. This action opens a Form with a Menu, allowing you to select the specific type of document to Upload. The list of file types is, in part, defined by each Institution.

Open the File menu; the file button is hidden behind the menu in the example figure above.

Use the Rename File to option to rename your file on Upload.

You can upload multiple files to each file type listed, but you can only upload one file at a time in the form shown above.

Click the Upload Multiple Files link (shown at the top of the Upload Documents form), you may select multiple files to upload (drag and drop files) into the window or browse to the location of your computer’s files and click to select files to upload.

When using the Multiple File Upload options, this system requires you to set the “File Type” for each file before it records the file uploads.

Your IRB may also require additional information (such as file version and date) depending on setup.

Another option for Uploading Files to protocols is to use the Replace function.

This option is handy for doing revisions to Protocols or Consent Forms.

Click the Context Menu on the file you wish to replace on the View Protocol page. The Context Menu is the small icon to the left of the file date.

Select Replace and this system will open a File Upload Form.

Upload the new file and it will replace the existing file, rather than listing the new file below the existing file.

Click the Replace button to complete the process.

The original file is maintained in a version control system in eCompliance.

Click the Versions option on the Context Menu to download a prior version of the file.

You can also Rollback to the original version or any subsequent version of the file.

Electronic Signature

If your institution requires electronic signatures, the Request Signatures button is enabled at the top of the View Protocol screen.

Follow the steps below to add required personnel in addition to yourself.

Click the Request Signatures button and the system sends an email to each person that was added as “required to sign electronically,” including yourself.

When the final person required to sign electronically has executed their signature, the Protocol will Submit automatically to your Faculty Advisor who will be notified by email.

When your Faculty Advisor signs-off, the Protocol will submit automatically to the IRB.