Entering Your Protocol Information

Entering Your Protocol Information

Accessing Reviewers Comments and Editing a Protocol Application

Making Revisions to an Approved Protocol

Renewing an Approved Protocol

Submitting an Adverse Event (AE) Report

Submitting a Deviation Report

Troubleshooting
 

Entering your Application Information 

  • NOTE: the first few pages of the e-Protocol submission are critical. Please follow the instructions below to help guide you through these first few steps.
  • If you have an existing protocol in the system, you can click on the Clone Protocol icon. This feature allows you to generate an exact copy of an existing protocol, with a new protocol number. You can then edit the cloned protocol and submit it as a new application.
  • To begin a new protocol application, click on the Create Protocol icon in the top right corner of the screen.
  • Enter the title of your protocol and click the Next button. Note: The protocol title entered must match the title of the informed consent document.
  • Enter the names of the key investigators. Key personnel include those individuals who work directly with subjects, or who handle data with identifiers. IMPORTANT: There will be two pages available to list all key personnel . All personnel listed on this first personnel page must have an e-Protocol login. If you are a student or a lab manager, you must enter a Faculty Sponsor on this page. An email will automatically be sent to the faculty sponsor when the application is complete. The faculty sponsor must approve (by email) the application before it will be considered by the IRB
  • Additional personnel may be added later (on the second personnel page, after selecting the review type). Individuals such as undergraduate student researchers without eProtocol logins can be added on the second page.

    NOTE: Personnel listed under "Other Personnel" will NOT have access to the protocol for editing unless they were entered using their eProtocol login. Personnel listed under any other category will have the ability to edit/view the protocol.

  • Each key personnel listed must have completed Human Subjects Training before the protocol information is submitted. In order to proceed to the next section, the Human Subjects Training Completed? checkbox must be filled in for each personnel listed. 
  • For guidelines on selecting the role for each personnel member, click the help icon (question mark) in the top right corner of the e-Protocol screen.
  • When key personnel with an e-Protocol login have been added, click Next.
  • Select the review type. You must decide whether your study falls under the biomedical or social, behavioral and educational category.
  • IMPORTANT! The selection of the category and review type determines what information will appear on the application. It is important that you select the category and review type relevant to your application. For definitions of these classifications, click the help icon (question mark) in the top right corner of the e-Protocol screen.
  • When the appropriate review type has been selected, click Next.
  • If you have selected Exempt or Expedited review, a window will appear where you will be asked to specify which category your research falls into. Once selected you will be taken to the second personnel page. If you have selected Emergency or Full Board review, you will be taken directly to the second personnel page.
  • Once you are on the second personnel page, your application has been created and saved in the system. If you exit the system prior to this point, your application will not be saved.
  • On this second Personnel page, you may add additional personnel, including individuals who do not have an e-Protocol login. For instructions, click on the help icon (question mark) in the top right corner of the e-Protocol screen.
  • Proceed through the application using the arrow icons or the page icons at the top of the screen.
  • If you need help or further instructions, click on the help icon (question mark) in the top right corner of any e-Protocol screen.
  • Remember to attach your Consent and Assent (if applicable) forms in the designated sections. NOTE: If your study is a collaboration with another institution, you must provide the IRB materials from the collaborating institution. In the Consent Form page, you must add the consent form from the collaborating institution. In the Attachments page, you must include the collaborating institution's IRB approval.
  • On the last page of the application, remember to include all other attachments (flyers, advertisements, questionnaires, etc.). If your study is funded, please attach a copy of the grant proposal, even if the grant was submitted through OGCA.
  • When all material has been entered, click Check for Completeness in the menu on the left before submitting the application. A list of any missing information, with a link to the appropriate page will appear. If all information is complete, you will see the message “Protocol information is complete,” indicating that you can submit your protocol.
  • To submit your protocol, click on Submit Form in the menu on the left. Note: you will not be able to edit your protocol once it is submitted. If you are ready to submit, click Yes in the pop-up box. A message will appear telling you that your protocol has been submitted.
  • Once the protocol is checked by the IRB staff and accepted for review, you will receive an email indicating the level of review (exempt, expedited, or full board) and the meeting date of the IRB (if applicable).
  • You will receive another email once the protocol has been reviewed by the IRB, stating the decision of the IRB. If changes need to be made to the protocol, you will need to login to e-Protocol and open the appropriate protocol for editing by clicking on the item listed for that protocol under Protocol Event . Within this protocol you will find comments from the reviewers and/or the IRB staff. You must make all recommended changes and re-submit the protocol.  

Accessing Reviewers Comments and Editing a Protocol Application

  • If the IRB has requested revisions to an application before it can be accepted, you will receive an email indicating so. In this event you will need to login to e-Protocol and open the appropriate protocol for editing.
  • On the main page you will see the protocol listed and under Protocol Event it will say Comments Received (Cycle #).
  • Click on Comments Received to access the protocol and comments from reviewers.
  • On the next page you will see all comments from the IRB regarding your protocol application. Any comments that are marked as ‘Response necessary for approval' must be attended to.
  • The section of the protocol application to which the comment is referring will appear at the top of each comment box. If the comment requires a modification to the protocol application, you must go to the appropriate section of the application and make any necessary changes.
  • You must also write a response in the box under each comment. If you have made a change to the application, it is acceptable to write something along the lines of “see changes in application” in the box. When your response has been entered click Save . Note: The cycle numbers are listed in the top left corner of the screen. Be sure that you are looking at the comments from the most recent cycle. To move to a particular cycle, click on the appropriate cycle number.
  • To make changes to the protocol, click on Get Protocol to open the protocol for editing. Go to the appropriate sections and make your revisions. Sections that have been modified will be indicated to the IRB. You will only see the latest text on your screen. However, for IRB members the changes will automatically be highlighted, and both the original and revised text will be available.
  • When you are ready to send your responses back to the IRB, click on Submit Form to submit your revisions and responses to comments.
  • Once the protocol has been approved by the IRB, you will receive an email stating so. You may not begin any part of the research project until you have received such notification.

Making Revisions to an Approved Protocol

  • From the main screen, click on the double arrow to the right of Protocols (Approved).
  • Click on the protocol number that you wish to revise.
  • A window will open with several options.
  • Click the circle beside Start Revision.
  • The protocol will open for you to edit. Go to the appropriate sections of the protocol and make your revisions. Sections that have been modified will be indicated to the IRB. You will only see the latest text on your screen. However, for IRB members the changes will automatically be highlighted, and the original text will be available.
  • Once your changes have been made, check that all information has been entered by clicking on Check for Completeness in the menu on the left. When you are ready to submit your revision, click on Submit Form in the menu on the left.
  • Once the revision is submitted, the protocol will appear in two places within your account. The originally approved protocol will appear under Protocols (Approved). The revision will appear with the same protocol ID on the main page of your account, with the Protocol Event as Submitted .
  • All future correspondence regarding the revision application will have the original protocol ID number, followed by [Amendment].
  • Once the revision has been reviewed by the IRB, you will receive an email stating the decision of the IRB. If changes need to be made to the protocol, you will need to login to e-Protocol and open the appropriate protocol for editing, by clicking on the item listed for that protocol under Protocol Event . Within this protocol you will find comments from the reviewers and/or the IRB staff. You must make all recommended changes and re-submit the protocol.
  • When the revision has been approved by the IRB, you will receive an email stating so. You may not begin any part of the research project until you have received such notification.  

Renewing an Approved Protocol

  • When approval for your protocol is about to expire, you will receive an email indicating that you must submit a renewal or final report form.
  • From the main screen, click on the double arrow to the right of Protocols (Approved).
  • Click on the protocol number that you wish to renew.
  • A window will open with several options.
  • Click the circle beside Start Renewal .
  • The protocol will open with a renewal form. Fill out all of the information on the form.
  • If your renewal involves changes to the existing protocol, including changes in the number of subjects, proceed to the appropriate sections, using the menu on the left of the screen, and make the necessary modifications. Sections that have been modified will be indicated to the IRB. You will only see the latest text on your screen. However, for IRB members the changes will automatically be highlighted, and the original text will be available.
  • Once your changes have been made, check that all information has been entered by clicking on Check for Completeness in the menu on the left. When you are ready to submit your renewal, click on Submit Form in the menu on the left.
  • Once the renewal is submitted, the protocol will appear in two places within your account. The originally approved protocol will appear under Protocols (Approved). The renewal form will appear with the same protocol ID on the main page of your account, with the Protocol Event as Submitted .
  • All future correspondence regarding the renewal application will have the original protocol ID number, followed by [Renewal].
  • Once the renewal has been reviewed by the IRB, you will receive an email stating the decision of the IRB. If changes need to be made to the protocol, you will need to login to e-Protocol and open the appropriate protocol for editing, by clicking on the item listed for that protocol under Protocol Event . Within this protocol you will find comments from the reviewers and/or the IRB staff. You must make all recommended changes and re-submit the protocol.
  • When the renewal has been approved by the IRB, you will receive an email stating so.

Submitting an Adverse Event (AE) Report

  • From the main screen, click on the double arrow to the right of Protocols (Approved).
  • Click on the protocol number for which you wish to submit the report.
  • A window will open with several options.
  • Click the circle beside Start Adverse Event Report .
  • The protocol will open with an adverse event form. Fill out all of the information on the form.
  • If your adverse event requires changes to the informed consent document, attach the revised document.
  • Check that all information has been entered by clicking on Check for Completeness in the menu on the left. When you are ready to submit your form, click on Submit Form in the menu on the left.
  • Once the adverse event report is submitted, the protocol will appear in two places within your account. The originally approved protocol will appear under Protocols (Approved). The adverse event report will appear with the same protocol ID on the main page of your account, with the Protocol Event as Submitted .
  • All future correspondence regarding the adverse event report will have the original protocol ID number, followed by [Report].
  • Once the adverse event report has been reviewed by the IRB, you will receive an email stating the decision of the IRB. If changes need to be made to the protocol, you will need to login to e-Protocol and open the appropriate protocol for editing, by clicking on the item listed for that protocol under Protocol Event . Within this protocol you will find comments from the reviewers and/or the IRB staff. You must make all recommended changes and re-submit the protocol.

Submitting a Deviation Report

  • From the main screen, click on the double arrow to the right of Protocols (Approved).
  • Click on the protocol number for which you wish to submit the report.
  • A window will open with several options.
  • Click the circle beside Start Deviation Report .
  • The protocol will open with a deviation form. Fill out all of the information on the form.
  • Check that all information has been entered by clicking on Check for Completeness in the menu on the left. When you are ready to submit your form, click on Submit Form in the menu on the left.
  • Once the deviation report is submitted, the protocol will appear in two places within your account. The originally approved protocol will appear under Protocols (Approved). The adverse event report will appear with the same protocol ID on the main page of your account, with the Protocol Event as Submitted.
  • All future correspondence regarding the deviation report will have the original protocol ID number, followed by [Report].
  • Once the deviation report has been reviewed by the IRB, you will receive an email stating the decision of the IRB. If changes need to be made to the protocol, you will need to login to e-Protocol and open the appropriate protocol for editing, by clicking on the item listed for that protocol under Protocol Event . Within this protocol you will find comments from the reviewers and/or the IRB staff. You must make all recommended changes and re-submit the protocol.

Troubleshooting

I cannot open my protocol.

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.

The options to "Start Renewal" or “Start Revision” are not available (you cannot click on it).

A revision or 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 as “Yet to submit”.

I do not see the form after I select "Start Renewal" or “Start Revision” and click OK.

If a renewal (or revision) 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.

I cannot submit my edited e-Protocol back to the IRB office.

Make sure you edit your e-Protocol AND also type your response to each comment in the respective textbox (Comments section). Save the responses, click Submit to IRB and confirm your decision.

I cannot submit my new e-Protocol.

Make sure you agree with the PD obligations. Click “Check for completeness” on the left menu. If it says the “Application Form is complete” it is ready for submission. If there are sections listed, you need to click on each section (link) and complete them before you can submit your e-Protocol.

Its been awhile and I haven't received any feedback to my responses to the IRB.

Please be sure that you have hit the "Submit to Manager" button and it is no longer showing on your screen. If you have successfully submitted your comments and the "Submit to Manager" button is no longer showing on your screen, the IRB has received your comments and may take up to 4-6 weeks to respond.

I can't find my approved protocol in order to submit a revision, a renewal, or a final report.

From the main screen of your e-Protocol homepage, click on the little white circle with the double arrows to the right of the heading "Protocols (Approved)". This will cause the heading to expand and display all approved protocols. Click on the protocol number that you wish to work on.  A window will open with several options. Click on the circle beside the option you want to do.