Protocol Name: short title from OnCore
Protocol Number: enter DFCI protocol number
(##-###)
DANA-FARBER/HARVARD CANCER CENTER
PROTOCOL SUBJECT ELIGIBILITY CHECKLIST
General formatting requirements:
FONT – Times New Roman
SIZE – at least 12 point
SPACING – at least 1.15
STUDY INFORMATION
Protocol number: enter DFCI protocol number (##-###)
Protocol name: short title from OnCore
Sponsor: add regulatory sponsor name
Lead DF/HCC Site: lead DF/HCC site
SUBJECT INFORMATION
Subject Name ___________________________________Date of Birth _____/_____/_____
Address___________________________________________________________________
Gender__________
Race______________ Ethnicity: (Circle one) Hispanic / Non-Hispanic / Unknown
Diagnosis__________________________ Treating Physician______________________
Hospital Medical Record Number(s) _____________________
Treating Institution(s) ________________________________________________________
Date Treatment is scheduled to Begin________________
RESEARCH TEAM INFORMATION
Name of Consenting Investigator _________________________________________
Name of Registering Person _____________________________________________
Contact Phone/Pager of Registering Person _______________________________________
TREATMENT ASSIGNMENT
Enter treatment arms/dose levels exactly as indicated in OnCore, including both the arm/dose
code and the arm/dose name. This information can be found in the PC Console > Treatment
Protocol Version Number:
Date Posted for Use: <OHRS use Only>
Protocol Version Date:
Eligibility Checklist Version:
Page 1 of 6
Protocol Name: short title from OnCore
Protocol Number: enter DFCI protocol number
(##-###)
Tab section of OnCore. Only currently enrolling treatment arms/dose levels can be listed in this
section. Contact CTRIO with any questions about arms/levels in OnCore.
Example:
___ EXP1: Expansion Arm 1 -- 60 mg Drug A, 500 mg Drug B
___ EXP2: Expansion Arm 2 -- 100 mg Drug C, 500 mg Drug B
If the arm/dose level is not yet built in OnCore (e.g., new studies, addition of new arms), ODQ
will complete this section.
Blinded Trials: If the protocol is blinded, use the following language. Do not include treatment
arm information.
N/A Blinded Study
Randomized Trials: If the protocol is randomized by ODQ and includes stratification, please
include the stratification criteria.
Example:
Age Group
___ 19-50
___ Above 50
ELIGIBILITY CRITERIA
Add windows/protocol indicated timeframes for all eligibility evaluations including labs, scans,
etc., as indicated in the protocol document. This information should be copied/pasted directly
from the protocol document.
If not required windows/timeframes are not specifically indicated in the protocol, use the
language below:
Unless otherwise specified in the protocol, all laboratory tests must be completed within 14 days
prior to the date of registration. Diagnostic tests, such as MRIs and CT scans, must be performed
within 30 days of the date of registration.
For BMT protocols, if not otherwise specified in the protocol, all eligibility tests must be
completed within 42 days of registration.
Inclusion Criteria
Copy/paste inclusion criteria exactly as it appears in the protocol document.
The following formatting changes must be made:
 If multiple inclusion criteria are combined into a single statement, break out each
criterion into its own bullet (example below)
Protocol Version Number:
Date Posted for Use: <OHRS use Only>
Protocol Version Date:
Eligibility Checklist Version:
Page 2 of 6
Protocol Name: short title from OnCore
Protocol Number: enter DFCI protocol number
(##-###)
ORIGINAL
Hepatic function: Bilirubin, aspartate aminotransferase (AST), and alanine
aminotransferase (ALT) ≤ 1.5 times the upper limit of the institution's normal range.
Subjects with liver metastasis may have an AST and ALT of ≤ 5.0 × the upper limit of
normal
REVISED
 Bilirubin < 1.5 x institutional ULN; Value ______, date ______,ULN ______
 AST < 1.5 x institutional ULN; Value ______, date ______,ULN ______
OR
 AST < 5 x institutional ULN for subjects with liver metastasis; Value ______, date
______,ULN ______
 ALT < 1.5 x institutional ULN; Value ______, date ______,ULN ______
OR
 ALT < 5 x institutional ULN for subjects with liver metastasis; Value ______, date
______,ULN ______




For any items that require a specific value (e.g., performance status) add a field to
indicate the observed value
For all lab values add a field to indicate observed lab value, ULN/LLN (if applicable)
and date of lab test (see example above)
For all fields that require a specific date or date range, add a field or fields to indicate
corresponding date/date range
Please format all inclusion criteria as follows:
o Font: Times New Roman
o Font size: 11 pt.
Examples:
 ECOG Performance Status of 0 or 1; Value ______
 Age > 18; Value ______
Exclusion Criteria
Copy/paste exclusion criteria exactly as it appears in the protocol document.
The following formatting changes must be made:
 If multiple exclusion criteria are combined into a single statement, break out each
criterion so that it is its own bullet (see example in Inclusion Criteria section)
 For any items that require a specific value (e.g., performance status) add a field to
indicate the observed value
Protocol Version Number:
Date Posted for Use: <OHRS use Only>
Protocol Version Date:
Eligibility Checklist Version:
Page 3 of 6
Protocol Name: short title from OnCore
Protocol Number: enter DFCI protocol number



(##-###)
For all lab values: add a field to indicate observed lab value, ULN/LLN (if applicable)
and date of lab test (see example above)
For all fields that require a specific date or date range, add a field or fields to indicate
corresponding date/date range
Please format all inclusion criteria as follows:
o Font: Times New Roman
o Font size: 11 pt.
Protocol Version Number:
Date Posted for Use: <OHRS use Only>
Protocol Version Date:
Eligibility Checklist Version:
Page 4 of 6
Protocol Name: short title from OnCore
Protocol Number: enter DFCI protocol number
(##-###)
CENTRALIZED REGISTRATION QUESTIONS
(Required if Office of Data Quality (ODQ) will register the subject in OnCore)
 Signed, dated informed consent
 Subject has been registered with external study sponsor (if applicable);
<< date ____________________ >>
<< Write “N/A” here __________ if not applicable for this subject >>
 The subject has not and will not begin treatment until email confirmation of DF/HCC
registration has been received by the study team (if applicable)
<< Write “N/A” here __________ if not applicable for this subject >>
 Coordinator has notified treating physician to discontinue any prohibited Standard of
Care (SOC) and/or Research treatment plans prior to the On Study date being entered in
OnCore (if applicable)
<< Write “N/A” here __________ if not applicable for this subject >>
 Subject is eligible and study investigator has confirmed subject eligibility (if study
investigator confirmation is required – refer to REGIST-104 for additional details)
 All required information is documented in the medical record or research file
<< If ODQ will register this subject in OnCore the information below is not required >>
<< Stop here and fax to ODQ (617-632-2295) along with the complete signed consent form
>>
Subjects must be registered between 8 am and 5 pm EST, Monday through Friday
In emergency situations when a subject will begin treatment after hours or on weekends –
please call (617-632-3761) and follow the detailed instructions for registration.
Treatment cannot begin until confirmation of registration is received from ODQ.
Protocol Version Number:
Date Posted for Use: <OHRS use Only>
Protocol Version Date:
Eligibility Checklist Version:
Page 5 of 6
Protocol Name: short title from OnCore
Protocol Number: enter DFCI protocol number
(##-###)
DECENTRALIZED REGISTRATION QUESTIONS
(Required if study team will register subject in OnCore)
Eligibility Exception(s)
(Required only if eligibility exception granted for this subject)
OHRS Other Event # for Eligibility Exception
IRB Approval Date for Eligibility Exception
Sponsor Approval Date for Eligibility Exception
ELIGIBILITY STATEMENT
Screening Staff
This subject is [
study.
Signature:
eligible /
ineligible /
eligible with exception] for participation in the
Date:
Printed Name (include credentials):
Enrollment Monitor
This subject is [ eligible/
study.
Signature:
ineligible /
eligible with exception] for participation in the
Date:
Printed Name:
Protocol Version Number:
Date Posted for Use: <OHRS use Only>
Protocol Version Date:
Eligibility Checklist Version:
Page 6 of 6