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eProtocol
Frequently Asked Questions (FAQs)
Who can log in?
Anyone with a Stanford University Network (SUNet) ID may log in to the eProtocol application. A SUNetID and password provide access to the Stanford University Network and its services, and identifies authorized users of these services. See the SUNet ID website for more information.
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System Requirements
To access the eProtocol application, you'll need a computer with an Internet connection.
Access to protocols
Once logged in to eProtocol, you will have access to see all those (and only those) protocols on which you have been listed in the Personnel Info section. You will only have access to edit those protocols on which you are listed as either:
You must have edit access for a particular protocol in order to start a Modification (Revision) or Continuing Review (Renewal) application for that protocol.
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Training Information
Hands-on eProtocol Training classes are generally offered several times throughout the year. Dates and registration info is posted on the general eProtocol help page.
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Is my project Human Subject Research?
All protocols involving both "research" or "clinical investigations" and "human subjects" must be reviewed and approved by the IRB before recruitment and data collection may start; a protocol must be submitted to the IRB via eProtocol.
For some protocols it might be difficult to tell whether they qualify as human subject research. Please consult the guidance Does My Project Need IRB Review? For further assistance contact the Research Compliance Office, or submit a Determination of Human Subject Research - Application to the IRB. More information is available on the Medical Research and Nonmedical Research pages.
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Understanding your HOME page
The first page you encounter after logging in to eProtocol is your HOME page. Your HOME page has two main sections that display all of the protocols
on which you have been listed in the Personnel Info section. This is how the sections appear:
You can expand or collapse these two sections by clicking on the arrows on the right of the gray section bar as shown above.
Protocols (In-Preparation/Submitted)
Think of this as your "work-in-progress" area. It displays all of your protocol applications that are not yet approved. This includes applications you have just begun
working on (new, modifications, continuing review), as well as those that have been submitted and are in various stages of the IRB review process. Protocol applications will
be displayed here until they are officially approved in the system. Please note that in some cases this may be after you have received your
hard-copy approval letter.
Protocols (Approved)
Think of this as your "work-completed" area. It displays a listing of your approved protocol applications. Click on a protocol number from the list to
have the option to view the most recent approved version of the protocol, or to start a modification or continuing review application. Remember, the option to start
a modification or continuing review application is only available to those listed on the protocol in a personnel role that grants EDIT access.
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Create a new protocol
There are now two ways you can create a new protocol, from scratch or from a copy of an existing protocol.
Create a new protocol from scratch
To create a new protocol, simply click on the CREATE PROTOCOL button in the upper right-hand corner of your HOME page.
You will need to enter basic information (such as Protocol Title, Personnel Information) before your application form will be generated, protocol number assigned, and the initial
information that you have entered is saved. Once you have your protocol application number, you may continue to complete the application, or exit the system and return at a later time to complete.
Create a new protocol from an existing protocol
To create a new protocol from an existing protocol, click on the CLONE PROTOCOL button in the upper right-hand corner of your HOME page and follow the instructions on the page.
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Submit a protocol to the IRB
After completing your protocol application form, you can submit it to the IRB by clicking on the SUBMIT PROTOCOL button in the left-hand menu of the protocol application form as shown below. You will need to have the protocol application open in EDIT mode.
Please be patient after clicking submit. The application will automatically check to make sure that all parts of the application form are complete. If the application is complete, a small window will open thanking you for submitting your protocol. If the application is not complete, then a window will open indicating the portions of the application that remain to be completed. Navigate to those areas and answer the questions before attempting to submit again.
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Returned protocols
After your protocol has been submitted, it will undergo an initial check by Research Compliance Office intake staff before it is assigned to an IRB for review. The protocol is checked to make sure the correct type of application form was used, that the application is complete, and that it includes all of the necessary attachments, etc. Sometimes it is necessary to Return a protocol. This releases the protocol back to you (with full EDIT capability) so that you may make any necessary adjustments. If a protocol is returned, an email notification is sent alerting you to the return. Also the Protocol Status that displays on your HOME page will be "Submission returned". You'll need to open the protocol and click the link in the left-hand menu labeled "IRB Return Notes " as shown below.
This will open a small window with information on the reason for the protocol return and instructions on how to proceed. When you are ready to re-submit the protocol, you simply click the SUBMIT PROTOCOL button, just as you did for the initial submission.
Respond to IRB comments
Once your protocol has been accepted, it will be assigned to a specific Institutional Review Board (IRB) for review and assigned a meeting date. Check your email regularly. You will receive an email for each major event in the review process, alerting you to when you need to log into the system and take a particular action. You can also see the status by looking at the protocol listing on your HOME page in the eProtocol application:
Click on the link in the Protocol Status column to access the comments page. A sample of what the comments page looks like is shown below:
You'll need to:
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Modifications (Revisions)
Before you begin a modification, you should consider the date that the current protocol approval will expire. Keep in mind that once a modification is submitted, you will not be able to start a Continuing Review (Renewal) application until the modification has been reviewed and approved. If the expiration date of your protocol is near, you should start a Continuing Review (Renewal) application instead. As part of the Continuing Review (Renewal) application, you may include any proposed changes to the protocol.
To start a Modification (Revision), follow these steps:
- On your eProtocol HOME page (the page you see when you first log in), look at your Protocols (Approved) listing. You may need to click the
at the right-side
of the section header to expand this section. - Click on the number of the protocol you wish to modify. A small window should open as shown below:
If the option to "Start Modification (Revision)" is not available (you cannot click on it) then:- You may not have EDIT access to this protocol. Select "Open in View mode" and click on the left-hand menu option "Personnel Info". Only those folks listed in the first four roles (PD, Admin Contact, Co-PD, Other Contact) have access to EDIT the protocol and start modifications.
- A modification (revision) or continuing review (renewal) may have already been started or is in-process for this protocol. Check on your HOME page in the Protocols (In-Preparation/Submitted) section to see if the protocol is listed there.
- Select "Start Modification (Revision)" and click OK.
PLEASE NOTE: If a protocol modification application does not open when you click OK, then you have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, etc. that are blocking your pop-ups. See instructions for allowing pop-ups in your browser. - Answer all of the questions on the Modification Form page, describing the changes that you wish to make. You will also need to go to the appropriate sections in the protocol application form and update your answers to reflect those changes.
- Submit the modification form when ready by clicking the SUBMIT PROTOCOL option in the left-hand menu.
Continuing Review (Renewals)
To start a Continuing Review (Renewal) application, follow these steps:
- On your eProtocol HOME page (the page you see when you first log in), look at your Protocols (Active) listing. You may need to click the at the right-side
of the section header to expand this section.
- Click on the desired protocol number. A small window should open as shown below:
If the option to start a Continuing Review application is not available (you cannot click on it) then:- You may not have EDIT access to this protocol. Select "Open in View mode" and click on the left-hand menu option "Personnel Info". Only those folks listed in the first four roles (PD, Admin Contact, Co-PD, Other Contact) have access to EDIT the protocol and start continuing review applications.
- A modification (revision) or continuing review (renewal) may have already been started or is in-process for this protocol. Check on your HOME page in the Protocols (In-Preparation/Submitted) section to see if the protocol is listed there.
- Select "Continuing Review" and click OK.
PLEASE NOTE: If a continuing review application does not open when you click OK, then you have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, etc. that are blocking your pop-ups. See instructions for allowing pop-ups in your browser. - Answer all of the questions on the Continuing Review Form page, including any changes that you wish to make. You will also need to go to the appropriate sections in the protocol application form and update your answers to reflect those changes.
- Submit the continuing review form when ready by clicking the SUBMIT PROTOCOL option in the left-hand menu.
Update protocol personnel
If there has been a change in the personnel related to a particular protocol, you'll need to include these changes as part of a Modification (Revision) or Continuing Review (Renewal) application. Follow the instructions on the top of the Personnel Info page in the application form.
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Print a protocol
You may generate an Adobe .pdf file of your protocol application form that can be printed or saved on your computer. In the left-hand menu of the protocol application form, click on the Print View option (shown below):
A small window will open:
Select an option and click OK. The Adobe .pdf file will be created and opened. You may save it to your computer by clicking File, then save as in the upper left-hand corner of the window.
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Close a protocol
To Close a Protocol, follow these steps:
- On your eProtocol HOME page (the page you see when you first log in), look at your Protocols (Active) listing. You may need to click the at the right-side
of the section header to expand this section.
- Click on the desired protocol number. A small window should open as shown below:
- Protocols with a REGULAR review type will see the options shown above and will need to select the option to start a FINAL REPORT application. The application should be completed and submitted to the IRB.
- Protocols with an EXPEDITED or EXEMPT review type will see the option to "Close Protocol" as shown below.
- Simply select "Close Protocol" and click OK. You'll see another window in which you'll confirm that the protocol should be closed.
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I click on EDIT but protocol does not open.
You have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, etc. that are blocking your pop-ups. See instructions for allowing pop-ups in your browser.
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I can't see my approved protocols.
Your approved protocols appear on your eProtocol HOME page (the page you see when you first log in) in the section labeled Protocols (Approved). It should appear towards the middle of your page.
You may need to click the at the right-side of the section header to expand this
section.
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I can't find the protocol I need to modify.
Please refer to the instructions for Modifications (Revisions). If you do not see a protocol listed in your Protocols (Approved) section, it may be that
you were not listed as personnel on the protocol.
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The option to "Start Modification" or "Start Continuing Review" is not available; it appears gray.
- You may not have EDIT access to this protocol. Select "Open in View mode" and click on the left-hand menu option "Personnel Info". Only those folks listed in the first four roles (PD, Admin Contact, Co-PD, Other Contact) have access to EDIT the protocol and start continuing review applications.
- A modification (revision) or continuing review (renewal) may have already been started or is in-process for this protocol. Check on your HOME page in the Protocols (In-Preparation/Submitted) section to see if the protocol is listed there.
I select "Start Modification" and click OK, but am brought back to the page where I started.
You have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, etc. that are blocking your pop-ups. See instructions for allowing pop-ups in your browser.
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I received an error stating "Session expire."
Your application was left idle for longer than 45 minutes and has timed out. Close all of your browser windows and log back in to eProtocol.
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I am trying to respond to IRB comments, but it appears as if there are none.
You might be confusing the IRB Return Notes item in the left-hand side of the application form with the IRB Comments page, which is used during the official review cycle. If you are attempting to access comments from the IRB for a protocol that has already been assigned to a meeting date, please see the instructions on how to respond to IRB comments. If your protocol was returned, please see instructions for returned protocols.
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I can't open the PDF of my protocol or approval letter.
Recent changes in security may require Internet Explorer 7 users to change settings to download PDFs using the Print View (or View Approval Letter) function in eProtocol. Please do the following to adjust your settings.
- In IE7 click on “Tools” in the Menu Bar
- Choose “Internet Options”
- Click on the “Security” tab at the top of the window
- Click on the “Custom Level” button
- In the Security Settings Window make sure the following are set to “Enable”
- ActiveX controls and plug-ins – “Binary and script behaviors”
- ActiveX controls and plugons – “Automatic prompting for ActiveX controls”
- Downloads – “Automatic prompting for file downloads”
- Downloads – “File download”
- Click “OK” in the Security Settings Window
- Click “Yes” to the Warning about changing security settings
- Click “OK” in Internet Options Window
Now you should be able to open the PDF of your protocol (or approval letter).
topHuman Subjects Federalwide Assurance Number: FWA00000935, 8/14/2001 - 3/5/2012
Medical IRB Nos. 01, 03, 04, 05, 06, 07 & 08 Nonmedical IRB No. 02
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