How to submit a Protocol Amendment Application in KC 5.2.1Jamie Van Natta, Sarah Langlois2/22/2016Version 3- Removal of unnecessary graphics

ContentsPart 1: Create the Amendment Application Record.............................................................................................................2

Navigate to the Currently Approved Protocol Application................................................................................................2

Create the Amendment Application Record......................................................................................................................2

Amendment Checkbox Reference List...........................................................................................................................3

General Info...............................................................................................................................................................3

Funding Source..........................................................................................................................................................3

Protocol References & Other Identifiers...................................................................................................................3

Protocol Organizations..............................................................................................................................................3

Subjects (Participant Types)......................................................................................................................................4

Questionnaire............................................................................................................................................................4

Add/Modify Notes & Attachments............................................................................................................................4

Areas of Research......................................................................................................................................................4

Special Review...........................................................................................................................................................4

Protocol Personnel....................................................................................................................................................4

Others........................................................................................................................................................................4

Part 2: Make Changes to the Amendment Application Record............................................................................................5

Complete the appropriate Amendment questionnaire(s).................................................................................................5

Updating the Amendment Sections..................................................................................................................................6

Part 3: Submit the Amendment Application.........................................................................................................................6

Request Signatures............................................................................................................................................................6

Signature policy as of 12-23-2015.....................................................................................................................................6

Social, Behavioral and Educational Committee.............................................................................................................6

Biomedical Committee..................................................................................................................................................6

Submit for Review.............................................................................................................................................................7

Very Important: Post-Submission, Signature Collection....................................................................................................9

Appendix A: The Protocol Attachments Folder..................................................................................................................10

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Part 1: Create the Amendment Application RecordAn amendment is a request by the researcher to make a change to a previously approved protocol. This can be simple administrative information, such as updating contact information on consent materials, or it can be something related to the study design, such as addition of data collection procedures or a subject cohort. Only protocols in active or exempt state can be amended.*Note: Prior to the action being performed, the protocol status must be in one of the following statuses "Active – Open to Enrollment", "Active – Closed to Enrollment", "Active – Data Analysis Only", or "Exempt". After the action is performed the protocol status remains the same, but there will now be a new record with a status of “Amendment in Progress”.

Navigate to the Currently Approved Protocol ApplicationYou will be using the currently approved version of the application as the basis for the amendment application. To find the currently approved protocol:

1. Click on the “Search Protocols” link in the IRB Protocols box of the Researcher landing page.2. Using the Protocol # field, type your protocol number in the format *2#####* in the box.

a. If you do not remember your protocol number, you can use any of the other fields such as Title or Investigator (PI).

3. Hit the enter key or click the “Search” button4. Scroll down to see your results.5. Click the “Edit” link in the far left column of the results.

a. If you do not see an “edit” link or your results do not show the protocol you are looking for, it is possible that your permissions are incorrect. Contact the Research Systems Team at 419-383-6651 or email Jamie.VanNatta@utoledo.edu.

Create the Amendment Application Record.1. Navigate to the Protocol Actions tab and then click “Show” on the Request an Action folder.2. Click “Show” on Create Amendment section.

NOTE: If you do not have the action “Create Amendment” and your protocol is in one of the eligible statuses listed above, contact the IRB office or the Research Systems Developer and request to be added as an aggregator to the protocol.3. Enter text that summarizes the reason for the creation of an amendment to the Protocol document in the

Summary section. Please list all changes, but be as succinct as possible. For example: Narrative update, consent form change and add Dr. Smith to personnel.

4. Select one or more portions of the Protocol document that you intend to amend in the Amend section. A description of what each checkbox allows you to amend follows.

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Amendment Checkbox Reference List

General InfoChecking General Info allows you to change the title and the Protocol Type.

Funding SourceChecking the Funding sources checkbox allows you to edit the Funding Sources folder on the Protocol tab as shown below.

Protocol References & Other IdentifiersChecking this box allows you to change two of the sections found under the Additional Information folder on the Protocol tab.

Protocol OrganizationsCheck this box if you need to modify your performance sites or external organizations.

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Subjects (Participant Types)Check this box if you are planning to modify your vulnerable populations.

QuestionnaireChecking this box allows you to see and change the answers on your original application. See Part 2 for examples of situations in which you may need to change the questionnaires.

Add/Modify Notes & Attachments Checking this box allows you to upload new attachments to your protocol. Even if this is a simple personnel amendment, you will need to upload a new COI form or training certificate so this area is almost always necessary. See Part 2 below for more examples of situations that will require additional attachments.

Areas of ResearchThis checkbox allows you to change the areas of research section found in the Additional Information folder on the Protocol tab.

Special Review This is an administrative area; you will not need to modify the special review tab.

Protocol PersonnelCheck this box if you need to add, remove, or change the role of personnel on the project. Remember that each new person will need a COI form and that will need to be attached under the “Notes and Attachments” tab.

OthersThis is an administrative function; you will never need to select this checkbox.

5. When you have finished selecting the sections and tabs you need to change for the amendment, click the “Create” button to cause a new Protocol document to be created. You are then able to make changes to the selected portions only.

*Note: Upon create action for the amendment, the system creates an amendment protocol with a protocol number derived from protocol number of the protocol being amended followed by a suffix of A001 for the first amendment, A002 for the second amendment and so on. Once the amendment protocol is approved, the changes are merged with the original protocol and the amendment protocol with the suffix of A00* becomes inactive.

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Part 2: Make Changes to the Amendment Application Record

Complete the appropriate Amendment questionnaire(s).Each committee has a different questionnaire or questionnaires that must be completed to file the amendment. You will find these questionnaires at the top of the Questionnaire list on the Questionnaire tab.

1. Navigate to the Questionnaire tab. You will see that there are 3 new Questionnaires available to you.

2. Click show for the questionnaire(s) that are appropriate to the committee to which you are submitting. There are 2 for the Biomedical (Biomed) Committee and 1 for the Social, Behavioral and Educational (SBE) Committee.

3. As you complete the amendment questionnaires, there may be additional forms that are required. These forms will be links, in black text, in the question and will need to be uploaded before submission on the “Notes and Attachments” tab. The process for uploading a file is re-printed in the appendix of this document for your convenience.*NOTE: If you cannot upload files, then you did not check the correct box during Renewal creation. See “Updating the Amendment Sections” for how to correct this issue. See also “Amendment Checkbox Reference List” for an explanation of the checkboxes and usages.

4. As you complete the amendment questionnaires, you may need to make changes to other tabs, folders and sections of the Protocol application. You can always save the questionnaire at any point and navigate to another tab to complete the changes before returning to the questionnaire. For example, if you are adding new personnel, you will need to describe them in the questionnaire, but also add them on the personnel page, just as you did during the initial application. If you are changing vulnerable populations, you will need to navigate to the Protocol tab and the Participant Types folder in order to add or remove populations. If you need further review or instructions on how to perform these changes, refer to the “Submit an Application” document on the IRB website.*NOTE: If you cannot edit a needed section of the application, then you did not check the correct box during Amendment creation. See “Updating the Amendment Sections” for how to correct this issue. See also “Amendment Checkbox Reference List” for an explanation of the checkboxes and usages.

5. As you complete the amendment questionnaires, you may need to make changes to the standard questionnaires you completed at application time. For example, if you are requesting more subjects or participants, you will need to modify the “Human Subjects Research” questionnaire. If you are adding new personnel you might need to indicate whether they are explaining or obtaining consent, which is found on the “Consent or Waiver Process” questionnaire. You can open and work on any previous questionnaire while working on the amendment questionnaires.*NOTE: If you do not see any questionnaires but the amendment questionnaires, you did not check the correct box during Amendment creation. See “Updating the Amendment Sections” for how to correct this issue. See also “Amendment Checkbox Reference List” for an explanation of the checkboxes and usages.

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Updating the Amendment SectionsIf you discover that you need to change a section that you did not originally select, you can return to Protocol Actions tab->Request an Action folder -> Modify Amendment Sections section and check a new checkbox.

1. Navigate to the Protocol Actions tab and then click “Show” on the Request an Action folder.2. Click “Show” on Modify Amendment Sections subfolder.3. Select or unselect one or more checkboxes that you intend to amend in the Amend section.4. Update the Summary field to reflect the additional changes if necessary.5. Click the “Update” button to refresh to include or exclude the previously selected portions of the Protocol

document. You are then able to make changes to the selected portions only.

Part 3: Submit the Amendment Application

Request SignaturesAd Hoc Recipients/Signature RequestsIn the former paper world, an amendment application would have to be signed by the PI and, for Biomedical applications of the Convened type, the department head or college dean before it was submitted to the IRB for consideration. In the new electronic system, this is still true. Electronic signatures are called Ad Hoc Approvals in KC.

Signature policy as of 12-23-2015

Social, Behavioral and Educational CommitteeFor all Social, Behavioral and Educational amendment applications, only the PI signature is required. If the submitting researcher is the PI then no signatures are required and you can skip to “Submit for Review.”

Biomedical CommitteeFor all Biomedical Exempt or Expedited amendment applications, only the PI signature is required. For all Biomedical Convened amendment applications, then two signatures are still required, the PI and the PI’s Chair. If the PI is the Chair, then the signature requirements are PI and College Dean. For all Biomedical amendment applications, if the submitting researcher is the PI then the PI’s signature is not required, but the Chair or Dean’s signature is still required for all Convened amendment applications.

1. Click “Show” on the Ad Hoc Recipients folder.

2. Select an action from the Action Requested list. For signatures, this action must always be “Approve” which is the default value.

3. Click the magnifying glass icon under to the word “Person.” This brings up a lookup screen.

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4. Type either the last name or the first name into the appropriate field. If you are not completely sure of the spelling, you can use * or % as a wildcard character to represent one or more unknown characters.

5. Click “Search”. You will be presented with a list of persons who match your search criteria. In this example, the search criteria was last name of “Trempe”

*PLEASE NOTE: If you did not find who you were looking for and want to start over, click “Clear”. This will remove all the criteria from the fields and you can try again with fewer criteria or using the wildcard characters to prevent spelling mistakes. 6. Choose the correct person by clicking the “return value” link in the far left column.7. Click “Add”. Please do not forget this step.

*Repeat as necessary until all desired people have been added. After a successful addition, the line item appears with a delete button that can be used as necessary. *PLEASE NOTE: Signatures are collected in the order that they are input, so always put in the PI first, and then any additional signatures if necessary for Biomedical convened amendment applications.

Submit for ReviewYou must submit the protocol amendment for review before it can be signed by the PI or any other faculty required.

1. Click “Show” on the Request an Action folder to display the available actions.

2. Click “Show” on the “Submit for Review” section.

3. Select Amendment for your Submission Type (or Resubmission or Response if apprpriate). 7

4. Select Submission Review Type. The Submission Review Type of an Amendment Application may be different than the Protocol Type. An amendment to a protocol originally submitted as Convened may be reviewed as expedited because the amendment does not affect the risk/benefit ratio. Read the “*Minor Modifications to Convened Research” expedited category carefully to determine if you can submit an amendment to convened research as expedited.

5. Ignore the Type Qualifier drop-down.6. Select the appropriate Committee to review your protocol. This will populate the Schedule Date box. 7. Select the next available Schedule Date. For the BioMed committee, the IRB meets monthly, so the meeting date

first choice will be the next available meeting. For the SBE committee, the IRB meets as necessary, so the meeting date is set far in the future. This date will be changed as necessary, so do not be concerned.

8. If your review type is Expedited, choose one or more Checklist items. Expedited reviews require the selection of a

category of research. Read each of the categories carefully. To see the full text of each category, click the button to the right of the text. This will pop up a small window with the text in a larger box. Close the window when you are done. You must choose at least one category from the list for an Expedited review type.

9. Click “Submit”.

After submission you will see the following message:

Congratulations, you have submitted an amendment to your protocol. Note that any ad hoc approvers must approve the amendment before it can be pre-reviewed by the IRB.

If you don’t see the page above, please check for errors in your application. Errors will be displayed in the Validation folder on Protocol Actions tab. The most common error is neglecting to mark “Complete” on all your attachments in the “Status” drop down box.

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Very Important: Post-Submission, Signature CollectionKC’s automatic notification system is currently not working. Upon submission, if you requested a signature, you must contact your signatory via outside means (email, phone) to inform them that you are ready for them to sign off on the protocol. If you have requested more than one signature, then the second signature will also need to be notified via outside means AFTER the first signature is collected.

You can check the status of your signature requests on the Protocol Actions tab, in the Route Log folder. In this example, I added 3 signature requests. The first person to sign off would be Dr. Dake.

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Appendix A: The Protocol Attachments FolderTo upload an attachment:

1. Click the “Show” button on the Protocol Attachments folder. This will expand the folder.

2. Choose the appropriate attachment type from the drop down.3. You can indicate a status at this time or not. If you do not indicate a status, or choose the “incomplete” status,

you will be allowed to upload the document, but you will not be allowed to submit your protocol for review. Prior to submission all protocol attachments must be marked as “Complete”.

4. Enter a description in the Description text box. This can be the document version number, or another identifying description. This is a required field.

5. Select your file by using the “Browse”button. You will be able to select any file on your local machine or on any mapped drive (for example z:/ or h:/).

6. (Optional) At this time you can choose to complete any of the other optional fields such as assigning a contact name, email or phone to this attachment or adding additional comments in the comments text box.

7. Click the “Add” button. Do not forget this step! 8. You will now see that your attachment has been added. You will also see that the attachment count in the

folder title has increased by one.*Repeat these steps until all your attachments have been uploaded.

To edit an attached file:1. Scroll down to the Attached Items section.

For the item you wish to edit, click the “Show” button.

2. If you wish to see the document currently attached click the “View” button.3. If you wish to change any of the fields, you can edit them as desired.4. In order to change the file, click the “Replace” button. This will clear the File Name box, and restore the

“Browse” button. Select your file by using the “Browse”button. You will be able to select any file on your local machine or on any mapped drive (for example z:/ or h:/).

5. Click the “Save” button to store any changes to the fields or files. If you do not click “Save” your changes will be lost.

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6. If you want to remove a file from the list and start over, use the “Delete” button. You will be asked to confirm your deletion. Click “Yes” to delete, or “No” to return to the list without deleting.

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