Office of Research Continuing Review/Study Closure - Office of Research

Continuing Review/Study Closure

All IRB-approved research must undergo continuing review before IRB approval expires. Some research does not require continuing review and will not be given and expiration date.

Studies given an administrative determination, such as Exempt, Not Research, or Research – Not HSR, do not require continuing review or closure.

If any of the following are ongoing you must apply for a new approval period:

  • research-related interactions or interventions with human subjects
  • obtaining identifiable private information
  • analysis of identifiable private information

If all of the above actives are complete you must apply for study closure.

We are transitioning to a new electronic application form for all post approval applications. The Post Approval Submission (PAS) Form is now live in IRBNet and can be used to submit Continuing Review Progress Reports, Amendments/Modifications, and Reports of New Information.

When applying for a new approval period or study closure you must submit your application and any supporting documents via IRBNet at least 45 days before the expiration date.

The form can be signed by the PI using the “Sign this Package” feature in IRBNet.

If changes to study personnel have occurred since the initial review or the last continuing review, submit an updated electronic Initial Review Application Form or FORM: Research Personnel List (HRP 215) to reflect the current personnel.

If you are proposing changes to the research at the time of continuing review include an application for a modification as well as marked and clean versions of any updated study documents in the continuing review package.

If you are submitting a reportable item at the time of continuing review, include complete the reportable new information item and supporting documents in the continuing review package.

Note: If the continuing or closure/final report review application is not received by the administrative due date found in the approval letter, you will be required to develop and implement a suitable corrective and preventive action plan (CAPA).

The preventive action plan is based on the root cause for the event and regulatory authorities will be looking for this action plan during any inspection or audit. Please note that an adequate preventive action plan almost never consists solely of training.  Instead, a process revision, checklist, calendar or other tool should usually be used to prevent similar events in the future.

Investigators must ensure that the CAPA plan is followed and should also conduct a follow-up internal audit to assess whether the plan actually prevented mistakes.

 

In This Section

Related Topics


 

Create New Package/Adding New Documents

UC Davis Demonstration Video: How do I submit a Continuing Review for review?

  1. Enter your user name and password at irbnet.org.
  2. Click the project title to open the protocol.
  3. From the left hand menu click “Create New Package.
  4. From the left-hand menu click “Designer”
  5. Click “Start a Wizard
  6. Click “UC Davis – Post Approval Submission Form
  7. Click “Next” to move through the form.
  8. Create and save marked versions (tracked changes) and clean versions (changes accepted) of updated study documents.
  9. Upload other study documents as needed. To upload documents click “Designer” from the left hand menu. There are two ways to upload documents:
    • Click “Attach New Document.” Locate the document(s) needed and hold the  “Ctrl” button on the keyboard while selecting all document(s). When finished, click “Open,” OR
    • Drag and drop files to the bottom right corner of the screen.
  10. Once documents are uploaded use the IRBNet Document Type and Description Guide to choose the correct IRBNet Document Type from the drop down menu for each document.
  11. To stack new a version of a document on previously reviewed versions, drag and drop the new version of the document onto the version from previous packages.
  12. To edit the Initial Review Application click the pencil icon at the far right. Using the “Jump To” feature, go to the information screen that requires updating and enter the changes. Click “Next” until all information has been completed. Click “Save and Exit.”
  13. Edit other project information, as appropriate
  14. Collect necessary signatures
  15. Submit the package

 

Editing the Initial Review Application

UC Davis Demonstration Video: How do I edit the Initial Review Application?

Historically the IRB has required researchers to provide “tracked changes” and “clean” copies of the protocol/description of study when submitting amendments/modifications to their protocols. It is not possible to submit tracked changes versions of the Initial Review Application because it is an online document. Instead, the document will be updated online, as described below. To ensure the IRB is able to locate and review all edits to this document the IRB requires that all changes be detailed within the Post Approval Submission Form by providing the following information; location of the change within the Initial Review Application (e.g. Research Location Information, HIPAA, Consent, etc.…), information removed, and information added.

Making edits to the Initial Review Application

  1.  Enter your user name and password at irbnet.org
  2. Click the project title to open the protocol
  3. From the left hand menu, click “Designer”
  4. Locate the Initial Review Application and click the pencil icon at the far right
  5. Using the “Jump To” feature, go to the information screen that requires updating
  6. Update as appropriate and click “Next”
  7. When finished updating click “Save and Exit
  8. The Initial Review Application is now updated

Note: IRBNet does keep historical record of all previously approved versions of the Initial Review Application.


 

Updating Existing Documents with Revised Documents Stacking

UC Davis Demonstration Video: How do I stack or what is stacking of documents?

“Stacking” is uploading a new version of a document that has already been reviewed by the IRB, thus creating multiple versions of the same document in IRBNet. To stack a document the study must have already gone through one review cycle. Prior to submitting updated documents to the IRB you must create a subsequent package by following the steps above. Once the package has been created click the Designer to access existing documents. When uploading a new version of an existing document follow the steps below:

  1. Enter your user name and password at irbnet.org
  2. Click the project title to open the protocol
  3. From the left hand menu, click “Designer”
  4. There are two sections in the Designer: “New and Revised Documents in this Package” and “Documents from Previous Packages.” Locate the document you wish to update in the “Documents from Previous Packages” section and click the pencil icon next to the document
  5. Click “Choose File
  6. Locate the file you wish to upload and click “Open
  7. Click “Update
  8. If appropriate, update the Description field
  9. The new version of the document is now “stacked” on top of the previous version of the document and has moved to the “New and Revised Documents in this Package” section. Click the stack of papers icon to view a list of all versions of the document.
  10. Stack like documents; tracked-changes versions should be stacked on previously reviewed tracked-changes versions, while clean versions should be stacked on previously reviewed clean versions.

 

Editing the Project Information Worksheet (For Projects Existing Prior to September 2015)

The Project Information Worksheet is a data collection tool that was used by IRB Administration for studies started prior to the development of the online Initial Review Application. All studies will have either a Project Information Worksheet OR an Initial Review Application. They should not have both. If you are making edits to an existing study, you may be asked to update the Project Information Worksheet.

  1. Enter your user name and password at irbnet.org
  2. Click the project title to open the protocol
  3. From the left hand menu, click “Designer”
  4. Click the pencil icon next to the Project Information Worksheet
  5. Using the “Jump To” feature, go to the information screen that requires updating
  6. Update as appropriate
  7. Click “Save and Exit
  8. The new version of the document is now “stacked” on top of the previous version of the document. Click the stack of papers icon to view a list of all versions of the Project Information Worksheet.

If you have used the online Initial Review Application for your submission, you do not need to create a Project Information Worksheet.


 

Re-opening a Closed Study

First, if the study has a sponsor, please always check with the sponsor to ensure the sponsor agrees that the study can be closed. Next, follow the process below that best fits your situation:

  • If the expiration date of your study has passed since you closed the study the IRB will need to conduct continuing review when it approves re-opening the study (e.g. the date you want to reopen the study is 01/01/2015 and the study expired on 12/31/2014)You will need to submit the Post Approval Submission Form.
  • If the expiration date of your study is less than 45 days from the date you want to reopen the study (e.g., the date you want to reopen the study is 01/16/2015 and the study will expire on 03/01/2015) the IRB will need to conduct continuing review when it approves re-opening the study. You will need to submit the Post Approval Submission Form.
  • If the expiration date of your study is more than 45 days from the date you want to re-open the study (e.g., the date you want to reopen the study is 01/01/2015 and the study will expire on 02/27/2015), you need to submit a Post Approval Submission Form.

The Post Approval Submission Form must include an explanation for the re-opening of the study and outline any changes being made to the protocol. Please remember to submit any additional documentation (e.g. research personnel list, protocol, consent forms) that will also be affected by the re-opening. The IRB Administration requires investigators to submit two copies of all revised documents:  (1) one copy should be in a “tracked changes” format so we can easily identify why has changed; and (2) one copy should be a clean document with no marks or tracking indicating the changes that have been made.


 

Responding to a Letter of Action

UC Davis Demonstration Video: How do I submit a response to a Letter of Action?

  1. Enter your user name and password at irbnet.org
  2. Click the study title to open the protocol
  3. Click “Project History
  4. Click “Create New Package
  5. To edit existing study documents, go to the “Designer” and click the pencil icon next to the document you wish to edit. Either upload the new version of the document or edit the on-line document within the system
  6. To add a new study document, go to the “Designer” and click “Add New Document.” Enter the document information, choose the file from your computer and click “Attach
  7. Edit other project information, as appropriate
  8. Collect necessary signatures
  9. Submit your package