Protocol Modification Form

The Protocol Modification Form requires the Principal Investigator's signature and date as well as other considerations. If any section of the form is incomplete, the form may be returned to you.

• Protocol  Modification Form [download Word doc] updated August 07, 2009

When to submit a Protocol Modification Form

The Protocol Modification Form must be submitted when any document related to a protocol is revised, e.g. adding/deleting a new funding source, an adverse event (AE) which adds a new risk to the consent form.

How many copies to submit

The IRB now requires ONLY the ORIGINAL DOCUMENTS.

• The original documents include:
  • Protocol Modification Form
  • One (1) track change version of each modified document to facilitate IRB review of the proposed modification(s)
  • Clean version of each modified document
  • All documents must be single-sided. Please do not use staples.
  • It is recommended that a complete set of the documents submitted to the IRB be kept for your records.

When does a modification require a NEW IRB application?

Generally speaking, when two of the three P's change (Purpose, Population or Procedures), a NEW application may be required.

Special Considerations

• Clinical Research Division (CRD) — Some modifications may require further review by the Scientific Review Committee (SRC) or Clinical Investigator Meeting (CIM) Chair, and a Biostatistician. Please download the Scientific Review Revision Form from the Research Trials Office / Protocol Office website. (This is not a requirement for Minimal Risk or Exempt studies.) If you have questions, please contact the Protocol Office.
  
• Sponsor Trials— When a Sponsor is requesting a modification, the letter/memo from the Sponsor must be submitted along with the PMF and the revised document(s).

• Public Health Sciences Division (PHS) — Some modifications may require further review by the SRC Chair or designee. Please download the "Modification Checklist for Scientific Review Committee" from the Research Trials Office website (Protocol Review Requirements / Ongoing Protocol Review).
  • Modification Checklist for Scientific Review Committee (for PHS)
  
  
• Cancer Surveillance System (CSS) — If the modification is requesting to use identifiable Cancer Surveillance System (CSS) data (e.g., data with names, addresses, SSNs, other identifiers) to recruit and/or review medical records of CSS patients, the Case Subject Recruitment Method Form must also be submitted along with the Protocol Modification Form to access such data. [download Word doc]
  
• Accessing Medical Records from UW or Seattle Children's — Studies that will access medical records from the University of Washington (UW) or Seattle Children's and have a waiver of consent, must complete the confidentiality agreement of the appropriate institution AFTER receiving IRB approval from FHCRC.

  Note: It is the PI's responsibility to obtain the signature from the respective institution's human subjects department and to submit the signed confidentiality agreement form to the FHCRC's IRB.

  • UW Confidentiality Agreement Form. Please contact the University of Washington Human Subjects Division at (206) 549-0098 with any questions regarding this document.
  • Seattle Children's Oath of Confidentiality Form. Please contact Seattle Children's IRB at (206) 987-3930 with any questions regarding this document.
• Approved, Accrual Pending — Requests to change your study status to Approved must include the final funding agreement and/or external committee's approval document (e.g., radiation safety committee) and if applicable, the response to the IRB Committee's minor contingencies per the result letter.  All requirements listed in the result letter must be submitted at the same time. 
• Reopening Accrual — Requests to reopen a study to accrual should include a justification — for example, a brief summary of interim results.
• Change in Funding - Please submit a completed Funding Source Supplement (updated October 14, 2008) along with a copy of the Funding Source Document.  Please go to the Funding Source (FSD) Review Policies for specific information regarding the review process for funding source documents.  A modification form is not required to remove a funding source from a study. 

Instructions

Prepare a Protocol Modification Form. The following information must be included and should be explicit.

• IR File Number of the already approved application
• Name of the principal investigator requesting the modification
• List of all the modification(s) and Rationale for each modification. A summary listing the specific changes to a document(s), the page number(s) that is/are being modified and the rationale for the change must be included with each Protocol Modification Form. If not, the modification may be returned to you. For example, "protocol, page 3, paragraph 5, adding the new risk of.... because....."
• If the Sponsor is requesting the changes, the memo/letter from the Sponsor must be submitted along with the PMF;
• Check the applicable Materials/Documents that are being added or being revised with this modification. 
• Level of Priority — Examples of valid reasons for priority review are revisions involving patients waiting for treatment, changes in risk, and confidentiality concerns. Printing deadlines, routine changes to study documents, and impending staff vacations are not considered valid reasons for priority review requests.
• Regulatory Considerations for IRB Review - check the appropriate checkboxes. 
  • Dose Change — If the modification involves either increasing or decreasing the dose, a summary of the change must be included.
  • Inclusion of a vulnerable population - If the modification involves the inclusion of a vulnerable population, please include the additional safeguards that will be added to the protocol to ensure the safety and welfare of this new population. 
  • If the modification involves the re-consent of previously enrolled research participants, include the re-consenting process.
• Change in Funding - please submit a completed Funding Source Supplement updated October 14, 2008
• Institutional Biosafety Committee Review
• Radiation Safety Committee Review

The form is protected. Use the mouse or TAB key to move between items. To check a checkbox, click the checkbox or press the "x" key.

Submitting revised documents: Use the "track changes" feature to identify changes on one copy, and include a "clean copy" of the document(s). Materials would include the protocol, consent form(s), letters of approach, etc. If the documents to be modified use acronyms, please be sure to spell each acronym completely when first using them. For example, Institutional Review Board (IRB).

Note to users of Word 2003: Please do not use "balloons" to show tracked changes. The display of changes is controlled on the Reviewing toolbar (View>Toolbars>Reviewing). On the Reviewing toolbar, find the "Show" pulldown; under "Balloons," check "Never" to prevent changes from displaying in balloons.

Modifications take two to three weeks to process for IRB approval. Once the modification receives final approval, the IRO will forward one copy of the stamped approved document(s) to the Contact Person.

If the IRB chair determines full committee review is warranted, the PI and contact person will be notified by email. The modification will be placed on the next appropriate agenda date.