In eProtocol, only the “Top Four “individuals listed on a study can edit the protocol and receive notifications. The edit roles include Protocol Director, Admin Contact, Investigator, and Other Contact.
Once the person gets added to one of the top four editing slots, they have edit access to the study. However, the individual being added won’t receive eProtocol-related emails (e.g., notifications of responses sent, etc.) until their personnel change has been officially approved.
Under ‘More Actions’ for ‘Active Protocols’ or ‘Non-Active Protocols’ the options that are available to users will be enabled according to their role. Other functions that can be performed by the top four are: start Continuing Review, start Modification, create a Report, clone a Protocol, close a Protocol
Other Personnel listed on the protocol only have view privileges and can only view the contents of the protocol. If you desire edit access, please contact the personnel listed in the top 4 positions and have them create a modification listing you in the edit role position and submit the protocol to IRB for approval.
You can create a new protocol from scratch or from copying (cloning) an existing protocol.
Create a new protocol from scratch
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.
If after entering the title, personnel info, selecting the application category and review type, nothing happens when you click CREATE, 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.
You may clone a previously approved protocol from the “Active Protocols” section of your eProtocol Dashboard. Select “Clone Protocol” from the “More Actions” drop down menu. You will be given a new eProtocol # once the protocol is cloned. The new protocol application should be edited to reflect your current project.
OPACS, or Outside Professional Activities Certification System, is Stanford’s online reporting and certification application that facilitates compliance with the Faculty Policy on Conflict of Commitment and Interest. All faculty investigators listed in the Personnel Info. section of an eProtocol application will automatically receive an email asking if they have any financial interests related to the protocol. They must complete the OPACS disclosure by answering “Yes” or “No” before the completed protocol can be submitted to the panel office.
Look for the Academic Sponsor in the Personnel Info section of the protocol:
Once they are entered into the system, click on the link “Academic Sponsor Review Form” and that will send that link to your Academic Sponsor to complete.
For Chart Review protocol application, waivers can be requested under the “Protocol Information” tab, section 5, by selecting the “Add” button and choosing the type of waiver.
For Expedited or Regular protocol applications, waivers can be requested under the “Protocol Information” tab, sections 13 and 14, by selecting the “Add” button and choosing the type of waiver.
From the eProtocol homepage, click on the protocol number and choose to open in edit mode. In the protocol left-hand menu, click “Submit Protocol.”
eProtocol 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 resubmitting
Once a protocol is submitted, you will not be able make edits or additions, unless requested as part of the review.
The IRB can convert regular, expedited, or exempt protocols to any of those versions; however, chart reviews can only be converted to expedited.
To convert a regular to a chart review, a new chart review protocol application will need to be created, the information should be copied over, and the regular protocol application should be deleted.
For IRB, SCRO or APLAC:
If you receive an email notification that your protocol is being returned by the RCO staff for additional revisions, launch the returned protocol from your eProtocol dashboard. Then in the left hand menu, choose “Return Notes.” A window will open with information why your protocol was returned and instructions on how to proceed, noting only those instructions for the current revision date. After you’ve followed the instructions and made any requested revisions, save your changes and click on Submit Protocol in the left-hand menu to resubmit. Responding promptly to Return Notes will help ensure that your protocol gets assigned to the next available meeting.
If a protocol is returned, click on the protocol number under Action Items (or "Resubmit for review") to open the protocol. Click on "BSP Return Notes" and make the requested changes to the protocol. Once the changes are made, click "Submit Protocol" to resubmit the protocol for review.
How do I respond to comments?
From the eProtocol homepage, find the protocol listed in your Action Items, and click on “Respond to Comments.”
Note: Make sure to choose “Respond to Comments” instead of clicking on the protocol number. You can’t see the protocol comments from the protocol form.
The comments/response page will show you a list of comments (or questions) from reviewers. For each question you need to enter a response AND make changes in the appropriate sections of your protocol. You can click “Get Protocol” to open your protocol in a separate window.
Once you have responded to comments and updated and saved your protocol, click “Submit to Manager.” This button is on the comments/response page. You will see a confirmation to let you know your responses have been sent.
Before you begin a revision/modification, consider the date that the current protocol approval will expire. Keep in mind that once a revision is submitted, you will not be able to start a renewal application until the revision has been reviewed and approved. If the expiration date of your protocol is near, you should start a renewal application instead. As part of the renewal application, you may include any proposed revisions to the protocol.
On your eProtocol homepage, find your protocol in the Active Protocols section. Click “More Actions” and choose “Start Revision.” Your protocol should open in edit mode. If nothing happens – check your pop-up blockers. If you are not listed in one of the top four roles in the Personnel Section (i.e., Protocol Director, Admin Contact, Co-Protocol Director, or Other Submitter), you will not have edit access; someone with editing privileges will need to submit the revision.
You can make any changes as needed. You can save this form and return to it later, it will be listed under your Action Items.
When you are ready to submit your revision, click Submit Protocol in the left-hand menu.
Here are instructions how to delete a revision, renewal, or report:
- Go to your dashboard (https://eprotocol.stanford.edu/mydashboard)
- Go to the Active Protocols section
- Find the protocol application that you would like to delete
- Click “More Actions”
- Select “Delete Activity”
- When comments by a reviewer are sent back to the research team, the protocol will appear in under the ‘Action Items’ of the researcher’s dashboard.
- Under ‘Action Required’ for the it will display a link ‘Respond to Comments’. To add comments, the researcher must click on this link which opens the ‘Comments’ page (see below).
- The Comments page displays all the comments from the reviewer which requires a response from the researcher. They can add the response in the text box labelled ‘Response’ and then must click the ‘Save’ button to save the response.
- After all the responses have been entered and saved, they must click ‘Submit to Manager’ which opens a window to confirm if they wish to submit the responses. Clicking ‘Yes’ will send the responses back to the panel manager.
- Once the responses are submitted the protocol will be moved from the ‘Action Items’ section to the ‘In Process’ section of the researcher’s dashboard which confirms the submission of responses.
Note: If the comments require updates to the protocol application form, the researcher can access the protocol by clicking on the ‘Get Protocol’ button or the protocol number link next to ‘Protocol Id’.
Not all users listed on a protocol can edit it. Only the personnel listed in the first 4 positions of the protocol ("Protocol Director", "Admin Contact", "Co-Protocol Director", and "Other Contact" or "Other Submitter" ) can edit or create a revision or renewal. "Other Personnel" and "Academic Sponsor" can view, but not edit the protocol.
SUNet ID is now mandatory for all personnel on the protocol. If anyone on your team does not have a SUNet ID, please contact your department administrator or the department of the PD listed on the protocol to obtain a SUNet account. VA Users, please contact Linda Wester at Linda.Wester@va.gov.
Under the top four spots, there is a link “Click here to add Other Personnel.” Anyone entered as “Other Personnel” will have view access to the protocol, but will not be able to make changes. Only personnel in the top four spots (i.e., Protocol Director, Admin Contact, Co-Protocol Director, or Other Submitter) will have edit access to the protocol. Anyone added as Other Personnel will have “view only” access. Before moving on to make additional revisions to the protocol, or submitting the personnel revision to the panel office, you must first click on "Confirm Personnel" to initiate the OPACS process
Personnel listed as Protocol Director, Admin Contact, Co-Protocol Director, or Other Submitter on currently approved APLAC protocols may place animal orders through the Veterinary Service Center’s AnimalTrax online animal ordering system, however you must use a valid SUNet ID in the Name field when entering their information into the eProtocol application Personnel Section. Other Personnel may also order animals in the AnimalTrax online animal ordering system, but will need someone in the top four roles or the Department Financial Administrator (DFA) to authorize the purchase.
When changing someone’s role within an APLAC eProtocol (e.g., moving someone listed as Other Personnel to the role of Other Submitter), you should follow these steps:
1. For the person(s) currently listed as the Admin Contact, Co-Protocol Director, or Other Submitter, click on “Clear” and click “Save”.
2. For the person(s) listed as Other Personnel, click on “Delete” and click on “Save”.
3. Add person(s) back onto protocol in the desired role(s), and click “Save”. Note: Be sure you have updated their experience and training, as applicable, for their new role.
4. If the protocol involves surgery and/or anesthesia, you must go to each applicable procedure and update the Surgeon Details and/or list of Anesthetists because eProtocol will remove previous entries whenever a person has been deleted/cleared.
For IRB, SCRO or APLAC:
On your eProtocol homepage, find your protocol in the Active Protocols section. Select "More Actions", then "Start Renewal/Continuing Review". If nothing happens – check your pop-up blockers.
You must answer all renewal questions and can make any changes as needed. You can save this form and return to it later; it will be listed under your Action Items. Whether you have personnel changes to the protocol or not, you must first click on "Confirm Personnel" to initiate the OPACS process before you will be able to make additional revisions to the protocol, or submit the renewal/continuing review to the panel office. When you are ready to submit your renewal/continuing review, click “Submit Protocol” in the left-hand menu of the protocol form.
If your renewal isn’t listed in the Action Items section, find it in the Active Protocols section. Select "More Actions", then" Start Renewal".
To renew a protocol, choose "Start Renewal" from the "More Actions" drop down menu in the left hand column. Once the renewal page is opened, select the radio button for renew with no changes or renew with changes. You will only be able to edit the protocol if you select "Renew with changes". Once you are ready to have the protocol reviewed, make sure to click the submit protocol button to submit the renewal for review.
From the eProtocol homepage, go to the Active Protocols section, find the protocol you want, and click “Download Approval Letter.” Your most recent approval letter will be downloaded and opened as a PDF.
To find prior approval letters, open the protocol in view mode. Click on “Event History” from the left hand menu. This will show you a list of activities for your protocol, oldest to newest. Find the activity you are looking for, and click “Approval Letter.” This feature is relatively new to eProtocol, so approvals from several years ago are not available. Contact our staff if you don’t see the approval letter you are looking for.
If you click to Download the Approval Letter and nothing happens, you may need to adjust your browser settings. Below are instructions for IE users. If you are using another browser, please contact the Help Desk for assistance. (Can someone work on streamlining this following section.)
1. In IE click on “Tools” in the Menu Bar
2. Choose “Internet Options”
3. Click on the “Security” tab at the top of the window
4. Click on the “Custom Level” button
5. In the Security Settings Window make sure the following are set to “Enable”
a. ActiveX controls and plug-ins – “Binary and script behaviors”
b. ActiveX controls and plug-ins – “Automatic prompting for ActiveX controls”
c. Downloads – “Automatic prompting for file downloads”
d. Downloads – “File download”
6. Click “OK” in the Security Settings Window
7. Click “Yes” to the Warning about changing security settings
8. Click “OK” in Internet Options Window
Now you should be able open your approval letter.
The protocol may still be under review, or it may have just recently been approved, and the panel is still creating it. It should be available shortly after the approval is entered into the system.
MPP stands for Multiple Project Protocol. A MPP is needed when there is more than one protocol referenced to a funding source. To provide sponsors with one approval date, a MPP is set up. It is considered an umbrella protocol and its purpose is to maintain a list of protocols for a funding source.
Whenever the funding source sponsor requests Institutional Animal Care and Use Committee
(IACUC) verification or animal subjects approval, the approval date of the MPP is given. This avoids having to provide multiple approval dates for each of the individual protocols. You cannot order or study animals under a MPP; it is established for administrative purposes only.
The grant PI, or his/her administrator, should submit a MPP at the same time the funding source is being added to the individual protocols. MPPs must be renewed annually, and should include an updated list of approved protocols under the MPP. Each PD with a protocol under the MPP umbrella is responsible for obtaining approval for their own protocol which may include review of the relevant grant proposal.
1. Log in to eProtocol.
2. Click CREATE in the upper right-hand side of the page.
3. Title: Enter a title that is the same as the proposal title, but add "MPP" at the end.
Enter the contact information for the PI of the grant in the Protocol Director section. In the experience
section, just write Grant PI.
Enter the contact information for the Administrative Contact. Be sure to select Not working with Animals.
Click on "Confirm Personnel" to initiate the OPACS process.
Species Name = "Other"
Common Name = MPP
Daily Census = "0"
Housing Location = "Other", then enter "MPP" on the next line
Number of animals per year should = "0"
6. Funding sources: Complete all the proposal information. Include:
SPO# (can be obtained by contacting your Research Process Manager)
7. Rationale: Complete:
a. Purpose of this research: Briefly describe the overall purpose of the
project, list the individual protocols, and describe how each contributes to that purpose (aims performed).
b. through e., insert "MPP".
8. Procedure: Complete one procedure.
Type = "Other"
Title = "MPP"
Pain/Distress = "C"
9. Attachments: Attach a complete listing (Excel or Word format) of all protocols that will be funded
by this MPP. List should include:
Principal Investigator Name
Save this document as it will need to be updated and resubmitted with every renewal of the MPP.
10. Certification: Click “Agree.”.
On your eProtocol homepage, find your protocol in the Active Protocols section. Select More Actions, then Start Renewal/Continuing Review. If nothing happens – check your pop-up blockers.
You can make any changes as needed. You can save this form and return to it later, it will be listed under your Action Items. When you are ready to submit your renewal/continuing review, click “Submit Protocol” in the left-hand menu of the protocol form.
If your renewal isn’t listed in the Action Items section, find it in the Active Protocols section. Select More Actions, then Start Renewal.
Only one version (revision or renewal) can be in process at a time. If a revision is in process for a protocol, a renewal cannot be created. If the revision was created in error, it can be deleted by going to "Action Items" and choosing "More Actions" at the right hand side, then deleting activity.
- Go to your dashboard (https://eprotocol.stanford.edu/mydashboard)
- Create protocol
- Enter a brief title
- Enter personnel (at least the PD and Admin Contact, which can both be you if desired)
- Choose “Medical” as Category
- Choose “Single Patient IND/IDE” as application type
- Click “Create”
Upload the following documents under section 16:
- Clinical treatment protocol
- Device manual
- Letter from Investigator including Patient Information (be sure to remove ALL patient identifiers)
- Treatment Consent form; please use the attached medical consent found under our Medical Research: Forms & Consent Templates
- Select “Compensation for Research Related Injury” language option 2
When the Stanford Investigator holds the IND, Sponsor-Investigator Research (SIR) training will need to be completed.
If you will be using a custom device:
A custom device is one that is made at a physician’s order for patients with a sufficiently rare condition or for a physician’s special needs (e.g., unique pathology or unique physiologic condition), as discussed in the FDA Custom Device Exemption guidance document. Contact the FDA (email@example.com) to determine whether a device meets this exemption. If the device meets this exemption, please retain the FDA correspondence for documentation purposes and no IRB protocol application is needed. If the FDA determines that an IDE or compassionate use IDE is needed for this device, then you will need to submit a single patient IND/IDE, as described above.