| Staff | - Protocol Staff updates
→ Includes change of Principal Investigator (PI)
| - Study teams update Protocol Staff in OnCore PC Console > Main > Staff tab
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| Short Title | | |
| Retrospective Chart Review | - Addition/alteration of data points collected on retrospective chart review studies
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| 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
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| 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
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| 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
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| 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
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| 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
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| 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
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| Protocol Level Financials | - Changes to protocol related financials where no contract changes are required
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| 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
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| 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
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