Subject Management Tip Sheet
OnCore Field
OnCore Location
Definitions
Additional Identifiers
(Subject)
Subject Console  Demographics 
Additional Subject Identifiers
Enter SWOG, SPORE, ACRIN or other ID from drop down list
Approved Date
Subject Console  Consent  Available
Consents  Approved Date
IRB approval date for the ICF(s) entered.
CRA Console
Subjects  CRA Console
CRA Console is designed to provide Subject information at a
Protocol level. All subjects accrued will be available
Consent
Subject Console  Consent  Consents
The ICF(s) presented to the subject. If the correct version of the
consent form does not auto populate after hitting select, be sure
the most current Consent has been loaded into OnCore® and
has been released. Do not add an incorrect consent to the
subject’s record.
Eligibility Status
Subject Console  Eligibility--> Eligibility
Status
Eligible: Subject meets all inclusion/exclusion criteria
Not Eligible: Subject ineligible, document reason (ex. Screening
procedure does not meet criteria
Eligible (O): Eligibility criteria Overridden (ex. Waiver). This
should NOT occur. In the very rare circumstance that a waiver is
needed, approval should be received from IRB, Sponsor, and PI
first.
Eligibility Status Date
Subject Console  Eligibility--> Eligibility
Status
The date eligibility status was determined
Expiration Date
Subject Console  Consent  Consents
 Expiration Date
IRB approval’s expiration date for the ICF(s) that was entered for
protocol. If no expiration date auto-populates, check PC
Console/Reviews/IRB tab to ensure that ICF was entered
properly into OnCore®.
Off Study Reason
Subject Console  Follow-Up  Subject
Off Study Reason
Adverse Event/Side Effects/Complications
Death
Other
Patient Lost to follow up/ completed
Protocol-defined follow-up completed
Withdrawn – investigator decision
Withdrawn – sponsor decision
Withdrawn consent
Off Treatment Reason
Subject Console  Follow-Up  Subject
Off Treatment Reason
Adverse Event/Side Effects/Complications
Alternative Therapy
Cytogenetic resistance
Death on study
Disease progression before active treatment
Disease progression, relapse during active treatment
Lost to follow-up
No treatment, per protocol criteria
Subject Management Tip Sheet
Other
Patient off treatment for other complicating disease
Patient withdrawal or refusal after beginning protocol therapy
Patient withdrawal or refusal prior to beginning protocol
therapy
Treatment completed per protocol criteria
On Arm Date
Subject Console Treatment tabOn
Arm Date
The date a subject is registered or randomized to the first (or
only) arm or the first day of a subsequent arm.
Follow Up Start Date
Subject Console →Follow-Up
The date the subject has started follow-up; may be end of
treatment date
On Study Date
Subject ConsoleTreatment tabOn
Study Date
IIT (Randomized) = date treatment is assigned
IIT (Non- Randomized) =consent signed date
Industry= date subject is registered
Cooperative Group= date subject is registered
On Treatment Date
Subject ConsoleTreatment tabOn
Treatment Date
The date of the first dose of drug, procedure, or research event.
If there is no treatment per protocol, leave this field blank.
Off Arm Date
Subject ConsoleTreatment tabOf
Arm Date
The last date of the dose of drug, procedure, or research event,
unless otherwise specified in the protocol
Off Study Date
Subject ConsoleFollow-up tabOff
Study Date
The date the subject has completed all protocol activity
including follow up
Off Treatment Date
Subject ConsoleFollow-up tabOff
Treatment Date
The date all treatment visit procedures are complete
On Follow-up Date
Subject ConsoleFollow-up tabOn
Follow-up Date
The date the subject has started follow-up; Day after end of
treatment date
Race
Subject Console  Subject
Characteristics  Race
Select the subject’s race from the choices available. The race
should match what is recorded in the subject’s medical record.
Role
Subject ConsoleOn Study tabSubject
StaffRole
There are more roles listed in the dropdown than are used at
the subject level. Indicate the following roles, and others can be
added as applicable:
Clinical Research Coordinator = Coordinator responsible for the
patient
Data Manager = if applicable
Treating Physician: Enter the Enrolling Investigator. This could
be either PI or a Co-investigator, if applicable.
Sequence Number
Subject ConsoleOn StudySubject On
Study Update
The ID number assigned to the subject by the protocol sponsor.
(Study Number)
Signed Date
Subject Console  Consent  Consents
 Signed Date
The date the subject signed the ICF(s). After entering and
clicking “Select Consents”, the current documents will auto
populate.
Start Date
Subject Console  On Study tab 
Subject Staff  Start Date
The date the staff member begins working with the subject.
NOT A REQUIRED FIELD.
Subject Management Tip Sheet
Status
Subject Console  Consent  Consents
 Status
The subject Consent, Refused, Consent Waived and Withdrawn
Status Date
Subject ConsoleEligibility tabStatus
Date
The date that eligibility was determined.
Stop Date
Subject Console  On Study tab 
Subject Staff  Stop Date
The date the staff member stops working with the subject. This
date may need to be added when a staff member leaves the
department and/or moves to another clinical trials team.
Study Site
New SubjectStudy Site
Select the site that the subject’s accrual should count toward. It
should be where the subject is enrolled and treated.
Subject Console
Subjects  Subject Console
The Subject Console is designed with a Subject focus providing
access to a subject’s demographic information, study status, etc.
Subject ID
Subject Console  Demographics 
Subject Demographics
DO NOT EDIT THIS FIELD. Should always be the MRN. Please
contact centralized admin if the MRN is not correct.
Subject Status
Subject Console  Upper Right Corner
of banner in Subject Console
The status header is a point in time rather than a specific step.
The status changes based on dates entered in associated fields
within Subject Console.
None (blank) = Subject has been not been presented consent.
Only the demographics information for the subject has been
entered.
Consented = Subject has been presented consent and has
accepted. **Note: You should never select “refused” for an
initial consent. See Status section above.
Eligible = The subject has been presented consent, has accepted
the consent and met all eligibility requirements.
Not Eligible = The subject has been presented consent, has
accepted the consent but DID NOT meet all of the eligibility
requirements.
On Study = The subject has signed/accepted consent, has met
eligibility requirements and has been registered to the study.
On Treatment = The subject has signed/accepted consent, has
met eligibility requirements, has been registered to the study
and has begun treatment.
Off Treatment = The subject started treatment but has now
stopped receiving treatment.
On Follow-up = The subject is in the follow-up phase of the
study.
Withdrawn = The subject has discontinued participation in the
research study.
Off Study = The subject is completely off of the study and alive
at study completion.
Off Study (Expired) = The subject is off study and is deceased.
Transfer Date
Subject ConsoleOn Study
tabTransfer Date
The date the subject officially transfers to UCD to receive
treatment on protocol. This is typically only used if the subject
Subject Management Tip Sheet
was already registered to the study and has moved/changed
treatment sites.
Verified By
Subject Console Eligibility
tabVerified By
Enter your last name and first initial. (e.g. Broach, D.)
Version Date
Subject ConsoleConsent tabVersion
Date
ICF and HIPAA Version Dates should be the UCD Version Date.
Sponsor Version date should be listed in the description.