INSTRUCTIONS FOR A

NEW STUDY SUBMISSION

1. Enter your eIRB username and password to login.

The home page of the eIRB will display.

General navigation instructions

The system is designed in a tabular format. As a study staff member or PI, the tabs “My Inbox”, “IRB”, and “Home” will be shown. Click on “IRB”.

On the second tabular line, under “IRB”, studies can be accessed by clicking on the “Submissions” tab.

On the left-hand side of the screen are the options to create a new study or report new information.

Once a submission is created in the eIRB system, click “Save” and then “Continue” to advance through the screens.

There are “?”s throughout the smartform that, when clicked on, provide more information about the question or field.

2. Click on the blue bar named “Create New Study”.

3. The Basic Information section of the Smartform will display with questions 1-9. All questions with asterisk (*) are mandatory fields and must be completed prior to advancing to the next screen.

The answer to the question “Will an external IRB act as the IRB of record for this study?” is always “No”.

4. To upload a document in question 9, click the Add button. A pop-up screen will display, “Add Attachment”. To select a document from your computer clilck on “Choose File”. Then complete questions 2 and 3. By click “OK” will return you to the previous screen of Basic Information. The user has the option to click “OK and Add Another”. This will allow the user to select multiple documents to upload. When the last document is uploaded click the “OK” to exit the pop-up screen.

5. Once the Basic information in complete, click “Save” then “Exit”, which will allow you to return and work on the new study at a later time. Or click “Save” then “Continue” to advance to the next screen of the Smartform.

6. The “Funding Sources” screen will display. Please add the funding information including grant or organization funding by clicking the “Add” button. A pop-up window will display to allow you to enter the funding information.

In question 1 the ”…” (three dots) allows you to select from an organization list within the system. Helpful hint: Use the percentage sign (%) at the beginning of the search word to find all names.

(The filter defaults when looking for organization to “Name” )

Then click “Go”. A short list will display. Click the correct radio button and click “OK”.

The selected organization with populate the “Funding organization”. Click “OK” to return to the previous screen.

Alternative process:

The eIRB has a smart lookup functionality. You can start typing in the Funding organization and a drop down list will appear. Select an organization and populate the “Add Funding Source” popup window. You then click ok and it will be added to the Funding Sources screen.

To attach files, click “Add”.. A pop-up screen will display, “Add Attachment”. To select a document from your computer clilck on “Choose File”. Then complete questions 2 and 3. Click “OK” to return to the previous screen. You have the option to click “OK and Add Another”. This will allow you to select multiple documents to upload. When the last document is uploaded click “OK” to exit the pop-up screen.

7. Click “Save” and “Continue” button and advance to the next screen of the Smartform.

8. The Study Team Members section will display. Under #1, all study team members, excluding the PI, are listed. In #2, all (including the PI) study team member documentation including CITIs, COIs, Biosketches, and Letters of Support are uploaded. Click the add button to begin identifying study team members.

The “Add Study Team Member” popup window will display. The ”…” (three dots) allows you to select an individual from a list within the system.

The filter defaults when looking for organization to “Last”. If the last name is not known, you can select the drop down menu for other filters.

A short list of individuals will display. Select the radio button to identify the study team member and click “OK”.

Complete the “Add Study Team Member” screen as appropriate.

The screen will return the Study Team Member.

Alternative process:

The eIRB has a smart lookup functionality. You can start typing in the name and a drop down list will appear. The user can select a name and populate the “Add Study Team member” popup window.

9. The “External team member information” is where the study team members’ documentation will be uploaded. Click the “Add” button or use the Drag and drop file to upload functionality in the question 2 area on the screen.

10. The “Submit a Document” popup with display. You can choose a file or drag and drop the file.

11. Once the documents are uploaded the screen will return the Study Team Members. Click “Save”, which will allow you to return and work on the new study at a later time. Or select the “Continue” button and advance to the next screen of the Smartform with an automatic save

12. The Study Scope will display. Please make the appropriate select for each of the 3 questions. Click “Save” and then “Continue”.

13. The Local Site Documents screen will display. There are three sections to upload documents. The first section is for the consent forms to be used in the study. In the second section, recruitment material should be uploaded. This can include advertisements, surveys or scripted dialog. The third section is for other attachments. This area should be used to upload any documents related to equipment, questionnaires, risk assessments, safety inspections or other documents. Each area uses the “Add” button to allow you to select files from their computer.

To use the drag and drop functionality, you must be in the ADD Attachment popup window.

14. Once all the documents wanted are attached click “Save”, which will allow you to return and work on the new study at a later time. Or select the “Continue” button and advance to the next screen of the Smartform with an automatic save.

15. The Additional Information screen will display. This screen contains NASA specific questions and all five questions will need to be answered.

16. Click “Save” then “Continue”. The Final Page will display. Click the Finish or Exit.

17. The workspace for the New study will display. Once the study is ready for the IRB review, click the “Submit” on the left side of the screen, under the blue buttons.

18. A statement will appear and confirmation for study submission.

19. Click “OK”, then you will be asked to enter your credentials. Click “Submit”.

20. The Study created home page will display and the legend in the center of the screen will indicate the study in the Pre-Review phase.

If an IRB reviewer needs clarification the submission will be sent back to the PI and an automatic email from the eIRB system will be sent. The “Clarification Requested” oval will be highlighted in orange until a response is submitted. The legend in the center of the screen can be referenced to determine the status of the submission.

The submission will change to Non-Committee Review or Committee Review once processed through Pre-Review by the IRB office.

Non-Committee Review means that the submission will be handled out of board.

Committee Review means that the submission will be reviewed at the full board meeting.

The IRB office is available for questions and assistance anytime during the submission.