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Study Amendment Submissions

Study amendments can occur at any timepoint in a protocol lifecycle, including during study start-up and after open to accrual.

Study teams will use the REDCap Amendment Submission Survey to determine if protocol changes must be submitted and processed as an amendment. A protocol-specific link to the REDCap Amendment Survey is found in the protocol’s OnCore record, within the PC Console > Documents/Info > FAQs tab (OnCore login required).

Note: If the correction is a result of a new protocol version or updated budget/payment terms, this is not a correction. This is a normal amendment submission.

The table below outlines exclusion criteria that determines when an amendment is not required:

  • If protocol changes fall outside of the criteria below, an amendment IS required.
  • If protocol changes ONLY include one or more of the items below, an amendment is NOT required.
    • NOTE: A correction may need to be submitted for updates to released calendars, financials or Billing Grids that do not require a full amendment; please see Corrections section below.

Amendment Exclusion List

CATEGORYEXCLUSIONNOTES
Staff
  • Protocol Staff updates

    • → Includes change of Principal Investigator (PI)
  • Study teams update Protocol Staff in OnCore PC Console > Main > Staff tab
Short Title
  • Short Title change
Retrospective Chart Review
  • Addition/alteration of data points collected on retrospective chart review studies
Informed Consent Form (ICF)
  • Changes to the ICF only

    • → Risk, injury or HIPAA language no longer required to be submitted
  • Study teams upload the IRB approved ICF to OnCore
Inclusion/Exclusion
  • Changes to inclusion/exclusion criteria that DO NOT affect the schedule of events, Billing Grid or consent forms
  • Study teams enter IRB Reviews and upload documents, as required in OnCore
Accrual/Enrollment
  • Changes in enrollment numbers (increase or decrease) or accrual duration/completion dates

  • Accrual/enrollment for an arm, cohort or sub-study is closed or temporarily suspended

    • If other arms, cohorts or sub-studies are still enrolling and the Protocol Status needs to remain Open to Accrual, please email CTMS@fredhutch.org

    • If ALL arms, cohorts or sub-studies are closed or temporarily suspended to enrollment, please update Protocol Status
Advertisements / Subject Materials
  • Addition of, or changes to, advertisements or other subject materials
Sponsor Correspondence
  • Correspondence from sponsors that do not affect the schedule of events, Billing Grid, budget, Epic orders, clinic implementation, and/or drug dosing/administration
  • Study teams enter IRB Reviews and upload documents, as required in OnCore
Sponsor / CRO
  • Change in sponsor or CRO name only with NO change to budget, holder of funds, or OnCore invoicing sponsor or financial build -> e.g. Sponsor X is now doing business as Sponsor X, Inc.

  • IND holder Sponsor Changes
  • Change in invoicing sponsor requires a REDCap submission as protocol and subject related procedures need to be reassigned to new sponsor

  • If UW or FH Non-oncology studies, email IND Sponsor Change to CTMS@fredhutch.org

  • If Oncology study, email RegulatoryAffairs@fredhutch.org
Recruiting Sites
  • If the recruiting site already exists within the UWFH Research System

    • → *regardless of protocol's billing
Schedule of Events / Billing Grid
  • Changes that affect a part of the study or visits with NO active or future participants

  • Calendar footnote updates that do not affect the schedule of events, Billing Grid, budget, Epic orders or consent forms

  • Changes to ‘clinically indicated’ or ‘as needed’ procedures that DO NOT affect the schedule of events, Billing Grid, budget or consent forms

    • → e.g., additional visits, repeat tests if abnormal results are found
  • Study teams enter IRB Reviews and upload documents, as required in OnCore
Adverse Events
  • Treatment of Adverse Events without protocol prescribed procedures that DO NOT affect the schedule of events, budget or consent forms
  • Study coordinators enter additional visits/procedures in OnCore and billing notes in Epic to capture these situations
Negotiated Budget
  • Changes that DO NOT change protocol or subject related costs or milestones that DO NOT require a CTA amendment or change to OnCore financial build

    • → e.g., increase in the max number of invoiceable items
Invoicing Addresses
  • Changes to Remit To/Bill To address

    • → e.g., contact person or mailstop has changed
OnCore Financial Parameters
  • Changes to screen fail ratios, screen fail maximum or OSR maximum NOT requiring a CTA amendment

    • → e.g., change that can be implemented via sponsor email approval
Protocol Level Financials
  • Changes to protocol related financials where no contract changes are required
Investigator Brochure
  • Updates that do not affect the schedule of events, Billing Grid, budget, or Epic orders

  • Study teams upload redlined document(s) to REDCap Intake Study Form via document upload

  • Study teams enter IRB Reviews and upload documents, as required in OnCore
Study Manuals
  • Updates that do not affect the schedule of events, Billing Grid, budget, or Epic orders
  • Study teams upload redlined document(s) to REDCap Intake Study Form via Document Upload

  • Study teams upload updated manual(s) to PC Console > Documents/Info
A research site is added during an in-progress build.
  • It is before coverage analysis and Clinical Readiness Meeting (CRM) for oncology studies
  • It is to update an existing form (like an IDS request)

    • → in these cases, Study team must notify CTMS/CTO or CRT if applicable, using existing build ZD ticket for study
An amendment request IS required if:
  • If it’s during or after coverage analysis

  • If the changes impact calendar or billing grid

  • If the changes have a new redcap form/survey to complete

If there are change(s) NOT described in the table above, an amendment submission is required. 

Protocol Amendment Activation Workflows

Amendments submitted prior to Open to Accrual (OTA) will continue to follow OTA Activation Workflows. Amendments submitted after OTA will follow a 2-step amendment workflow, utilizing amended billing grids upon IRB approval of the amended protocol. Pre-OTA and post-OTA amendment activation workflows are available here (recommend logging into OnCore before clicking link).

Corrections

Updates to a released OnCore calendar, financials, and/or billing grid – that DO NOT require a full amendment submission- may be submitted as a correction via the REDCap Amendment Queue using the following steps:

  1. Access the study-specific REDCap Amendment Queue hyperlink in OnCore’s PC Console > Documents/Info > FAQ tab.
  2. Begin the survey for “Changes to my study what next?”, select the change category “Correction only to released OnCore Calendar, Billing Grid, or Financials”.
    • NOTE: If the study is in startup OR if there’s an active amendment (a Task List with ‘In Progress’ status), email the correction to the active startup/amendment communication thread with CTMS or UW CTO. Depending on the stage of the build, CTMS and UW CTO will determine if the correction can be incorporated into the existing build request or if a correction submission via REDCap is required.

For additional questions on amendments or correction submissions, please email CTMS@fredhutch.org.