Modifications

Overview

This page describes submitting a Modification for studies when the Fred Hutch IRB is the IRB of record. (For studies overseen by an external IRB, see How to Ask for an External IRB Review instead.)

This page covers the following information:

• When to submit a Modification to the Fred Hutch IRB
• How to submit a Modification to a study
• How to submit a Modification to a participating site
• Special considerations

For additional information, see the Fred Hutch IRB policy on Modification to Ongoing Activities.

When to Submit a Modification to the Fred Hutch IRB

In general, any change to an IRB-approved research study must be submitted to the IRB for review and approval before the change is implemented*.

A Modification must be submitted when any of the following changes is proposed on an existing research study overseen by the Fred Hutch IRB. This list is not exhaustive.

• A change to the research plan, consenting process, population, planned enrollment, procedures, source of subjects, source of data or specimens, or other aspects of the research outlined in the initial application.
• A change to documents including the protocol, consent, consent script, advertising, questionnaires, or any other study documents that are participant-facing or used to interview or survey a participant.
• Updates to drug or device documentation including revised Investigator’s Brochures (IBs), drug package inserts, or device instructions. The sponsor’s cover letter or cover email must accompany an IB update.
• Addition of protocol-related documents that communicate changes to study conduct, such as sponsor memos, dear investigator letters, etc.  These will be finalized (stamped). 
• Editorial modifications or corrections to documents (i.e., changes to font, corrections of typos or re-wording of phrases, etc.).
• Addition or removal of a funding source.
• Addition or updates to translated documents and the associated certification of translation.
• Addition or removal of a Cancer Consortium location that is under the purview of the lead file PI.
  • NOTE: Addition of a participating site outside the Cancer Consortium, or a Cancer Consortium location for which the lead PI does not have oversight, requires a reliance agreement and submission of a Participating Site Supplement and addition of a site to the lead file. In other words, this is not done via a Modification process. Contact reliance@fredhutch.org for additional information.
  • If adding the University of Washington as a location engaged in the research, documentation of UW Zipline authorization to rely on the Fred Hutch IRB must be included. For more information, see: https://www.washington.edu/research/hsd/is-the-uw-irb-the-right-irb/how-to-ask-for-a-non-uw-irb/
  • If adding Seattle Children’s (SCH) as an engaged location, an “Acknowledgement of Reliance on an External IRB” letter from SCH must be included as part of your submission. For instructions on how to obtain this letter, review Section A of the SCH-FH Guidance for Relying.
• A change in PI of the IRB file. This must be  submitted with an acceptance memo from the proposed new PI, and in general documents may need to be updated to list the new PI.
  • NOTE: If the change in PI is for a temporary leave (that lasts less than 3 months such as for parental leave), this should be documented by submitting a memo to have on file for the interim period. The PI should not be changed in the system or on the documents in this context.
• Changes in study team members only if those study team members need access to view, edit, or be designated as a PI Proxy in Hutch IRB.
• Addition or removal of a Certificate of Confidentiality (CoC). Note, the consent form may also need to be updated to include or remove language regarding CoC protections.

The following does not require a modification: 

• Changes to study documents that are internal to the study team, such as Clinical Research Forms, Physician-to-Physician letters, checklists used by the study team, internal SOPs, etc.
  Note: In some instances the IRB may specifically request submission of one of these documents, such as to support the Corrective and Preventive Action Plan proposed in association with a Reportable New Information (RNI) submission.

Please contact IRO@fredhutch.org or the assigned IRB Coordinator on the study if there are any questions about whether a specific change requires a Modification.

*The Fred Hutch IRB does not allow planned protocol deviations. The only exception is when a change is necessary to avoid immediate hazards to enrolled participants on the study and there is insufficient time for prospective IRB approval. If this exception is used, the PI must then submit a Reportable New Information submission to account for the unapproved change to research. If the change is proposed to be implemented moving forward, a Modification submission is also required. Consult with IRO@fredhutch.org if there are questions about this policy.

How to Submit a Modification to a Study

Helpful Resource: Online training to Create a Modification in Hutch IRB

First, complete your Modification Supplement, which is required to be attached to all Modification submissions in Hutch IRB, except when the only change is to study team members. This form provides additional information to assist the IRB in performing their review. Please pay particular attention to question 2. This question assists IRO staff in appropriately routing a modification for review and helps the IRB better assess the changes to the research. (Selecting “None of the above” is rarely the correct option. Please assess this question carefully to avoid unnecessary delays in the review process.)

In Hutch IRB, to modify a study:

1. Navigate to the study’s workspace and click the big blue Create Modification/CR button.
2. Select the type of submission. The options are a Modification / Update or a Modification and Continuing Review. 
   • Note:  If you plan to turn in a substantive Modification, we discourage you from combining it with the CR submission because there is no way to separate the two later. If the IRB has concerns with the Modification, the entire combined submission would be delayed. Minor changes can be combined with the CR, but otherwise please plan to submit a separate, stand-alone Modification.
3. Next, the Modification Summary page opens. Fill in the requested information in the SmartForm:
   • Indicate the current study status.
   • Summarize the modifications. Do not just list the documents being changed. You must also describe the rationale for the changes.
   • Attach your completed Modification Supplement (exception: This form is not required for Mods only requesting a study team member update).
4. Below the Modification Summary page, the complete study record is unlocked for you to make changes to any of the prior responses or to documents already attached to the study record.
5. Once all your changes to the SmartForm are ready, click Exit in the bottom lefthand corner.  The submission is still in Pre-Submission status. You can copy the submission link to route the draft to the PI or other team members for review before submission to the IRO.
   
6. IMPORTANT: The PI or a PI Proxy must click Submit to get the submission into IRO’s hands.
   

Additional tips:

• Submit clean Word versions of all documents whenever possible. If you do not have a version in Microsoft Word (e.g., the Sponsor’s protocol), you may submit a PDF document; however, a tracked changes document is then also required.
• To update an existing version of a document (Word or PDF) in the system, use the Update button to add a clean copy of the newly edited version on top of the existing document. This creates a version history of the document in the system. Please do not delete the existing version and then re-add because we lose the version history that way.
  
• For revised documents that you only have in PDF, you will also click the +Add button to add a tracked changes PDF of the document.  (Note that Hutch IRB is unable to accept Adobe PDF Portfolios. Single PDFs should be submitted instead of a Portfolio.)
• Consider how you want your documents to appear on your approval letter when naming them in Hutch IRB. Please be descriptive and clear - for example "Protocol Version 3" instead of just "Protocol". Additionally, if the sponsor or other parties have expectations about how documents are to be listed on the approval letter, please name them accordingly. (To rename existing documents in Hutch IRB, use the Update button found next to the document to be renamed.)

How to Submit a Modification to a Participating Site (pSite)

Helpful resource: Online training on Creating and Managing a Participating Site in Hutch IRB

For Multi-Site Studies Where Fred Hutch IRB is the IRB of Record for Participating Sites 

If the study is being modified, generally the lead file changes must be reviewed and approved before participating sites will be reviewed (generally, those study updates to the site materials would then qualify for expedited review).

For example, changes to the consent template should be submitted in the lead file first before you apply the changes to the site-specific consent forms (because the IRB may require changes to the consent template). 

TIP: If changes from a lead file are to be applied across many participating sites, you are welcome to consult with the IRO to obtain a pre-review of one site Modification before submitting all of the site Mods, to streamline efforts and clarifications that may be needed prior to IRB review.

For a pSite Modification

First, work with the participating site to complete the Modification Supplement – Participating Site form. This is the site-specific version of the standard (study-level) Modification Supplement form. The site PI or designee must sign this form. 

Only employees within the Cancer Consortium have access to Hutch IRB for security reasons, so it is the responsibility of the Fred Hutch study team to coordinate and facilitate the pSite’s IRB submissions for the life of the pSite on the study. It is also the responsibility of the Fred Hutch study team to provide IRB-approved documents to the pSite for their use in conducting the research.  

In Hutch IRB, to modify a pSite:

1. Navigate to the site’s workspace and click the big blue “Create Modification” button.
   • Note:  The system does not allow pSite mods to be combined with a continuing review submission.
2. The Modification Summary page opens. Fill in the requested information in the SmartForm:
   
   • Indicate the current study status for this participating site.
     
   • Summarize the modifications. Do not just list the documents being changed. You must also describe the rationale for the changes.
   • Attach the completed Modification Supplement – Participating Site form.
3. Click Continue. The complete pSite record is unlocked for you to make changes to any of the prior responses or to documents already attached to the site record. Click through each page of the pSite record to add any changes needed.
4. Once all the changes are ready, click Exit in the bottom corner.  The submission is still in Pre-Submission status. You can copy the submission link to route the draft to the PI or other team members for review before submission to the IRO.  (Site staff outside the Cancer Consortium do not have access, so you can print to PDF to share the draft submission with them as needed.)
   
5. IMPORTANT:  The lead PI or PI Proxy must click Submit to get the submission into IRO’s hands.

Review the “Additional Tips” in the preceding section, as those apply to a pSite Modification as well.