Study Amendments

Study Amendment Submissions

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).

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

  • If protocol changes ONLY include one or more of the items below, an amendment is NOT required.
  • If protocol changes fall outside of the criteria below, an amendment IS required.

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
  • Increase in enrollment numbers or accrual duration/completion dates

  • If an arm, cohort or sub-study is now closed to accrual or enrollment
Advertisements / Subject Materials
  • Addition of, or changes to, advertisements or other subject materials
Sponsor Correspondence
  • Correspondence from sponsors with no changes to procedures 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 or holder of funds
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, Epic orders or consent forms

  • 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, Epic orders or consent forms
  • Study teams upload updated manual(s) to PC Console > Documents/Info

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).

For additional questions, please email CTMS@fredhutch.org.