GD305-001
Title
Informed Consent Form Review Checklist: Pre-REB Submission
GD Code
GD305-001
Effective Date
31MAR2023
GD Version
1.0
INSTRUCTIONS FOR USE
Copy and paste the headers, footers, and all content from this Guidance Document, starting with page 2, into
a new word document. Modify the “Study Specific Elements” section, and any other areas, as appropriate for
the study protocol in use. Once the content has been finalized, edit the footer of the document to contain the
following information:
 Project Name or Protocol ID
 Protocol Version that the checklist applies to
 Document Version and/or Date
GD305-001 – ICF Review Checklist: Pre-REB Submission
Confidential
Page 1 of 6
Investigator: ___________________________ Site Number: _______________________
Protocol Name: _________________
Protocol Version: ________________
ICF Type (Main/Sub-study): __________
INFORMED CONSENT FORM REVIEW CHECKLIST: PRE-REB SUBMISSION
Section 1: General Review – Essential Elements
REQUIRED ICH/GCP ELEMENTS
YES
NO
N/A
COMMENTS OR SUGGESTED MODIFICATIONS
YES
NO
N/A
COMMENTS OR SUGGESTED MODIFICATIONS
A. Language:
(1) Language used in the document is as non-technical as practical.
(2) Language used in the document is not coercive and does not cause the
subject or the subject’s legally authorized representative (LAR) to waive or
appear to waive any legal rights, or release or appear to release the
investigator, sponsor, institution or its agents from liability due to
negligence.
B. All pages are present and numbered correctly.
C. Study Identification:
(1) Protocol Number
(2) Protocol Title
(3) Sponsor Name(s)
(4) Version Control (date and/or number)
(5) Investigator Name
Section 2: Description/Purpose – Essential Elements
REQUIRED ICH/GCP ELEMENTS
A. Statement that the study involves research.
B. Description / purpose of the study.
C. Expected duration of the subject's participation in the study.
D. Study procedures to be followed, including all invasive procedures.
E. Identification of those aspects of the study (any procedures) which are
experimental.
F. Study treatment(s) and probability for random assignment to each
treatment.
GD305-001 – ICF Review Checklist: Pre-REB Submission
Confidential
Page 2 of 6
Investigator: ___________________________ Site Number: _______________________
Protocol Name: _________________
Protocol Version: ________________
ICF Type (Main/Sub-study): __________
G. Subject’s Responsibilities:
(1) Explanation of the subject’s responsibilities.
(2) Consequences of a subject’s decision to withdraw from the study and
procedures for orderly termination of participation by the subject.
H. Approximate number of subjects involved in the study.
Section 3: Risks, Benefits & Alternatives – Essential Elements
YES
REQUIRED ICH/GCP ELEMENTS
NO
N/A
COMMENTS OR SUGGESTED MODIFICATIONS
NO
N/A
COMMENTS OR SUGGESTED MODIFICATIONS
A. Reasonably foreseeable risks (side effects) or inconveniences
(discomforts) to the subject and, when applicable, to an embryo, fetus, or
nursing infant.
B. The particular treatment or procedure may involve risks to the subject (or
to the embryo or fetus, if the subject is or may become pregnant) which are
currently unforeseeable.
C. Contraceptive requirements for Women
D. Contraceptive requirements for Men
E. Any reasonably expected benefits to the subject or to others. When
there is no intended clinical benefit to the subject, this must be stated.
F. Alternative procedure(s) or course(s) of treatment, if any, that may be
available to the subject.
Section 4: Confidentiality – Essential Elements
REQUIRED ICH/GCP ELEMENTS
YES
A. Records identifying the subject will be kept confidential and, to the extent
permitted by the applicable laws and/or regulations, will not be made
publicly available.
B. The clinical monitor(s), auditor(s), REB, and regulatory authority(ies) will
be granted direct access to the subject’s original medical records for
verification of clinical study procedures and/or data, without violating the
confidentiality of the subject, to the extent permitted by the applicable laws
and regulations.
C. By signing a written informed consent form, the subject or the subject's
LAR is authorizing such access.
D. If the results of the study are published, the subject’s identity will remain
confidential.
GD305-001 – ICF Review Checklist: Pre-REB Submission
Confidential
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Investigator: ___________________________ Site Number: _______________________
Protocol Name: _________________
Protocol Version: ________________
ICF Type (Main/Sub-study): __________
E. For Government-regulated studies (HC, FDA, NIH, etc.), a statement
that notes the possibility that the agencies may inspect the records needs
to be included.
F. The confidentiality language in the site-specific ICF document is
consistent with the sponsor’s template language, or has been approved by
the sponsor, if different.
G. Statement that the study records will be kept for 25 years for Health
Canada regulated trials.
Section 5: Compensation and/or Treatment for Study-Related Illness/Injury and Liability – Essential Elements
YES NO
N/A COMMENTS OR SUGGESTED MODIFICATIONS
REQUIRED ICH/GCP ELEMENTS
A. In the event of study-related injury, a disclosure of the compensation
and/or treatment available to the subject.
B. The study-related injury language in the site-specific ICF is consistent
with the sponsor’s template language, or has been approved by the
sponsor, if different.
C. Anticipated prorated payment, if any, to the subject
D. Anticipated expenses, if any, to the subject for participating in the study.
Section 6: Patient Contacts – Essential Elements
REQUIRED ICH/GCP ELEMENTS
YES
NO
N/A
COMMENTS OR SUGGESTED MODIFICATIONS
N/A
COMMENTS OR SUGGESTED MODIFICATIONS
A. Person(s) to contact regarding:
(1) subject rights (IRB, REB or subject advocate)
(2) study questions
(3) a study-related injury
Section 7: Voluntary Participation & Termination – Essential Elements
REQUIRED ICH/GCP ELEMENTS
YES
NO
A. Participation is voluntary.
B. The subject may refuse to participate in the study, at any time, without
penalty or loss of benefits to which the subject is otherwise entitled.
C. The subject may withdraw from the study, at any time, without penalty or
loss of benefits to which the subject is otherwise entitled.
GD305-001 – ICF Review Checklist: Pre-REB Submission
Confidential
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Investigator: ___________________________ Site Number: _______________________
Protocol Name: _________________
Protocol Version: ________________
ICF Type (Main/Sub-study): __________
D. Foreseeable circumstances and/or reasons under which the subject’s
participation in the study may be terminated by the physician/study
investigator or sponsor without the subject’s consent.
E. The subject or subject’s LAR will be informed in a timely manner if new
information becomes available that may be relevant to the subject’s
willingness to continue participation in the study.
Section 8: Informed Consent – Essential Elements
REQUIRED ICH/GCP ELEMENTS
YES
NO
N/A
COMMENTS OR SUGGESTED MODIFICATIONS
YES
NO
N/A
COMMENTS OR SUGGESTED MODIFICATIONS
A. Statement that the subject is providing informed consent.
B. Signature and date lines for:
(1) Subject
(2) Person administering consent
(3) LAR
C. A signed and dated copy will be given to the person signing the consent
form (ICH requirement)
D. If applicable, provision for the assent of a minor or others who can only
be enrolled in the study with consent of the subject’s LAR.
*ICH-GCP Sections referenced: 4.8*
OTHER SUGGESTED ELEMENTS (Non-Essential)
The ICF should be on site letterhead
The ICF should state the protocol amendment number
If study is double-blind, when/how code may be broken
Contains no promotional statements regarding safety or efficacy of
investigational drug or therapy.
The following statement on the English version of ICF’s used in Quebec:
“I have requested that this consent be provided in English. J'ai demandé
que ce formulaire de consentement soit rédigé en anglais.”
Statement that the subject's GP will be informed of his/her participation
Statement regarding concomitant medications or food/beverage intake if
applicable
GD305-001 – ICF Review Checklist: Pre-REB Submission
Confidential
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Investigator: ___________________________ Site Number: _______________________
Protocol Name: _________________
Protocol Version: ________________
ICF Type (Main/Sub-study): __________
A statement that all questions were answered
A statement that enough time was allowed for the subject to decide to
participate
If the IP has not been approved by Health Canada, this should be stated in
the ICF. If the IP has been approved for other indications, this should be
stated as well.
STUDY SPECIFIC ELEMENTS
YES NO
N/A
COMMENTS OR SUGGESTED MODIFICATIONS
Initial Review & Approval for Site REB Submission
By signing below, I confirm that:
Reviewer must check all of the following:
I reviewed the ICF for Protocol Content, Essential Elements and Study Specific Elements (if applicable).
Any deficient findings were communicated to the site and are documented on this checklist.
The ICF is approved for submission to the site’s REB, provided all of the requested changes documented on this checklist are made.
_______________________________
____________________________
______________
_________________________
Printed Name of Reviewer
Signature of Reviewer
Date of Review
Version Date of CARE approved ICF
GD305-001 – ICF Review Checklist: Pre-REB Submission
Confidential
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