OnCore Signoff Checklist
V13.5 Reference Guide
This manual has been adapted for this institution based on materials provided by Forte. For further detailed information refer to the
http://www.ucdenver.edu/research/ResearchAreas/OnCore. Additional information can be found at www.Onsemble.net.
OnCore v13.5
Signoff Checklists
Table of Contents
Introduction
…………………………………………………………. 2
Signoff Locations
…………………………………………………………. 2
Specification Signoff
…………………………………………………………. 4
Pre Award
…………………………………………………………. 4
Research Manager
…………………………………………………………. 4
Compliance
…………………………………………………………. 5
Principal Investigator
…………………………………………………………. 5
Protocol Status Signoff
…………………………………………………………. 6
Regulatory Administrator
…………………………………………………………. 6
Research Manager
…………………………………………………………. 7
Centralized Admin
…………………………………………………………. 7
Amendment Specification Signoff
…………………………………………………………. 8
Pre Award
…………………………………………………………. 8
Research Manager
…………………………………………………………. 9
Compliance
…………………………………………………………. 9
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Introduction
There are three different processes of signoffs which are:
1. Specifications
2. Protocol
3. Amendments
There is a 4 tiered sign-off process for specifications (calendars) and budgets.
Sign-offs will be incorporated into the calendar/budget development as part of
the protocol opening process to ensure that complete and accurate information is
present prior to the study opening. Following the specification signoffs are the
protocol signoffs, which is a 3 tiered process which begins after the calendar
builder releases the specifications. The Amendment Signoffs is a 2 tiered process.
A centralized administrator will work with the research team to identify users to
be assigned the signoff role.
Signoff Locations in OnCore
The signoff locations in OnCore are listed below.
1. Specification Signoffs
eCRFs/Calendars>Specifications>Calendar
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Signoff Checklists
2. Protocol Status
PC Console>Status
3. Amendment Signoff
eCRFs/Calendars>Specifications>Calendar
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Specifications Signoff Process Map
Specification Signoff
Pre Award
Research Manager
Compliance
Principal
Investigator
1. Specifications Signoff -Pre-award Checklist
The first specifications sign-off should occur after the calendar is built for a
protocol. This sign off should verify that calendar is complete and accurate
according to protocol and is sufficient to begin budget development and
budget negotiation. The following locations will help verification:

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eCRFs/Calendar-->Specifications-->Calendar
PC Console-->Documents/Info: Documents
Financial  Financial Console Parameters
Financial Financial Console Budgets
2. Specifications Signoff -Research Manager Checklist
The second specifications sign-off should occur after the calendar is built
for a protocol. This sign-off should verify that calendar is complete and
accurate according to protocol and is sufficient for clinical team to use for
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subject scheduling and subject visit verification. The following locations
will help verification:
 eCRFs/Calendar-->Specifications-->Calendar
 PC Console-->Documents/Info: Documents
 Financial Financial Console Budgets
3. Specifications Signoff -Compliance Checklist
Third Specifications sign-off should occur following IRB approval, Contract is
executed, and UCD approval of document consistency (ICF matched
contract, MTA and/or other study documents). The following locations will
help with verification:
 PC Console Main Sponsor Grant/ Contract Details
 Financial Console --> Parameters
 eCRFs/Calendar-->Specifications-->Calendar
4. Specifications Signoff -Principal Investigator Checklist
Fourth Specifications sign-off should occur immediately after Compliance
sign-off. PI should review final protocol and budget for any items of
concern including verifying PI and study site team fees are included
accurately. The following locations will help with verification:

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eCRFs/Calendar-->Specifications-->Calendar
PC Console-->Documents/Info: Documents
PC Console Main IND/IDE
PC Console Main Details
Financial Console --> Parameters
Financial Console --> Attachments
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Protocol Status Signoff Process Map
Protocol Signoff
Regulatory
Administrator
Research Manager
Centralized
Administrator
1. Protocol Signoff -Regulatory Administrator Checklist
First signoff should occur after the calendar builder has released the
specifications. The following items should be present and accurate. The
following locations will help with verification:
 PC Console-->Reviews: PRMS approval; IRB approval date and information
with IRB approved documents uploaded; other external committee
approvals (as applicable)
 PC Console-->Documents/Info: Documents (no IRB approval needed) are
present (as applicable)
o Informed Consent
o Protocol
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Signoff Checklists
o IRB Approval Certificate
PC Console-->Main-->Details: Verify Protocol details and accrual
information
PC Console-->Main-->Management: Verify IRB No. present, PRMS No.
present (if applicable), CTRC participation indicator, NCT ID
PC Console-->Main-->Staff: Verify PI and Primary contact present
PC Console-->Institutions: Participating institutions listed correctly, use of
Research Center IRB appropriately indicated.
2. Protocol Signoff -Research Manager Checklist
Second signoff should occur after all protocol opening steps have been
completed and the study is ready to be opened to accrual. The following
locations will help with verification:
 PC Console-->Main-->Details: Verify Protocol details and accrual
information
 PC Console-->Main-->Management: Verify toxicity scheme, automated
subject MRN, automated sequence No and randomization algorithm
settings; management group(s), study flowchart present (if applicable)
 PC Console-->Main-->Sponsor: Principal sponsor correct and other assigned
roles correct
 PC Console-->Notifications: Verify setting correct for this protocol
 PC Console-->Treatment: Arms present and correct per protocol; drugs/
devices and diseases correct
 PC Console-->Eligibility: checklist present if applicable
3. Protocol Signoff -Centralized Administrator Checklist
The following items should be confirmed for entry before the signoff
button can be selected:
 PC Console-->Main--Details: Investigational Drug or Investigational device
indicated correctly
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 PC Console-->Main-->IND/IDE: If IND or IDE applicable, relevant information
entered
 PC Console-->Main-->Management: NCT ID present
 PC Console-->Main-->ClinicalTrials.gov/CTRP: data present
 PC Console-->Status-->ClinicalTrials.gov: Verify protocol submission listed
 PC Console-->Status--CTRP: Verify protocol submission listed (Cancer
Center only)
 PC Console-->Main-->Management: appropriate Institutions, departments,
and management groups are entered
Amendment Specifications Signoff Process Map
Amendment Specification Signoff
Pre Award
Research Manager
1. Amendment Specifications Signoff -Pre-award Checklist
First specifications sign-off should occur after the new calendar version is
built for a protocol or the budget was revised. Pre-award staff should verify
that calendar and/or budget is complete and accurate according to
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protocol and/or contract amendment, and is sufficient to begin budget
development and negotiation
2. Amendment Specifications Signoff -Research Manager Checklist
Second Specifications sign-off should occur after the calendar is built for a
protocol and will follow Pre-Award Sign-off. Research Manager should
verify that calendar is complete and accurate according to protocol and is
sufficient for clinical team to use for subject scheduling and subject visit
verification.
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