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Managing Protocols

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How do I create a new protocol?

What is the OPACS process?

How do I submit a protocol?

How do I resubmit a returned protocol?

How do I revise or modify a protocol?

Who can edit a protocol?

Why can't I add someone without a SUNet id?

How do I change someone’s role in eProtocol?

How do I renew a protocol?

Where is my approval letter?

Why don't I see my approval letter?

How do I file a Multiple Project Protocol (MPP)?

How do I renew a protocol? or How do I submit a Continuing Review?

Why does it say another revision or renewal is in progress?

How do I create a new protocol?

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. 
Create a new protocol from copying (cloning) an existing protocol
Find the protocol you would like to clone, and click on More Actions. Select Clone protocol from the dropdown menu. This will copy the entire contents of the protocol into a new form and assign a new protocol number. YOU WILL BE PROMPTED TO REVIEW/CHANGE THE PROTOCOL TITLE BEFORE YOU CONTINUE, THEN YOU WILL NEED TO OPEN THE CLONED PROTOCOL FOR EDITING. AFTER UPDATING THE PERSONNEL INFO, CLICK ON "CONFIRM PERSONNEL" TO INITIATE THE OPACS PROCESS, THEN GO THROUGH EVERY PAGE VERY CLOSELY TO UPDATE INFORMATION THROUGHOUT THE PROTOCOL.

What is the OPACS Process?

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. 

How do I submit a protocol?

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.

How do I resubmit a returned protocol?

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.

For APB:

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.

How do I revise or modify a protocol?

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.

Who can edit a protocol?

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


For APLAC:

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.

How do I change someone’s role in eProtocol?

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.

How do I renew a protocol?

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".

For APB:

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.

 

Where is my approval letter?

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.

Why don't I see my 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.

How do I file a Multiple Project Protocol?

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. 
For APLAC
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.
4. Personnel:
      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.

5. Species:
      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)
      Grant Number
      Grant Title
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:
       Protocol Number
       Principal Investigator Name
       Protocol Title
       Procedures/Aims Performed
Save this document as it will need to be updated and resubmitted with every renewal of the MPP.
10. Certification: Click “Agree.”.

How do I renew my protocol? or How do I submit a continuing review?

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.

Why does eProtocol say that I already have a revision or renewal in progress?

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.