Informed Consent Review Checklist
Protocol number
Protocol Title
(add as relevant)
Content
Check the Language used
No coercive or unduly influential language is included
No language that causes the potential participant or the potential
participant's legal representative to waive or to appear to waive
their legal rights
Information does not release or appear to release the
investigator, the institution, the sponsor, or their agents from
liability for negligence
The language used is understandable and non-technical
Check that the following information on Study Design is included
The study involves research
The purpose of the study
The approximate number of participants involved in the study
The study treatment(s) and the probability for random
assignment to each treatment
Explanation of randomisation
Explanation of placebo
The study procedures to be followed, including all invasive
procedures
The amount of blood to be drawn and schedule of blood draws
Completion of questionnaires/diaries
Those aspects of the study that are experimental
The alternative procedure(s) or course(s) of treatment that may
be available to the participant, their important potential benefits
and risks
Impact on participants that should be included
The participant’s responsibilities
The reasonably foreseeable risks or inconveniences to the
participant and, when applicable, to an embryo, foetus, or nursing
infant
The reasonably expected benefits. When there is no intended
clinical benefit to the participant, the participant should be made
aware of this
The compensation and/or treatment available to the participant
in the event of study-related injury
The anticipated prorated payment, if any, to the participant for
study participation
The anticipated expenses, if any, to the participant for study
participation
That participation in the study is voluntary and that the
participant may refuse to participate or withdraw from the study,
at any time, without penalty or loss of benefits to which the
participant is otherwise entitled
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Yes
No
N/A
Page # / Comments
Content
The expected duration of the participant's participation in the
study
The foreseeable circumstances and/or reasons under which the
participant's participation in the study may be terminated
That the participant or the participant's legally acceptable
representative will be informed in a timely manner if information
becomes available that may be relevant to the participant's
willingness to continue participation in the study
Data processing and confidentiality
That the monitor(s), the auditor(s), the IRB or EC, and the RA(s)
will be granted direct access to the participant's original medical
records for verification of clinical study procedures and/or data,
without violating the confidentiality of the participant, to the
extent permitted by the applicable laws and regulations and that,
by signing a written informed consent form, the participant or the
participant's legal representative is authorising such access
That records identifying the participant will be kept confidential
and, to the extent permitted by the applicable laws and/or
regulations, will not be made publicly available.
If the results of the study are published, the participant’s identity
will remain confidential
Statement that sponsor is the data controller and will abide to the
relevant legislation and guidelines on data privacy concerning the
processing and use of participant’s personal data
Statement that although participant may be known by a unique
participant number, initials and date of birth may also be
collected and used by the sponsor to verify the accuracy of data
Statement that the results of the study containing participant’s
unique participant number, initials, date of birth, ethnicity and
relevant medical information may be recorded and transferred to
and used in other countries. The purpose of such transfer would
be to support regulatory submissions made by the sponsor.
Personal Data Protection Clause according to the data protection
legislation (list what applies)
Contact information
Name of the Sponsor
The person(s) to contact for further information regarding the
study and the rights of study participants, and whom to contact in
the event of study-related injury
Signature section
Statement that a signed and dated copy shall be given to the
person signing the consent form
The ICF includes statement that participant/legal representative
has read and understood the Patient Information Sheet (including
version#), has had enough time to review the information and has
had the opportunity to ask questions and obtain satisfactory
answers in understandable language
Signature space for;
- the participant
- the person administering the Informed Consent (if not the
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Yes
No
N/A
Page # / Comments
Content
Principal Investigator)
- Principal Investigator
- impartial Witness (where participant is illiterate or protocol
requirement)
- time of signature for all signatories if required by EC or client
- spaces for first and last names of all signatories in block letters
Document layout
The study is identified accurately:
- by protocol number
- by protocol title
- study name
- by EC reference number (if applicable),
- by regulatory database number (if applicable)
The Principal Investigator is identified by name
The ICF is appropriately version-controlled (version and date)
Each page is numbered in the format Page x of y
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Yes
No
N/A
Page # / Comments
Country/site/EC specific requirements
PM to add any country/site/EC specific requirements below
Name of author of the ICF:
Position:
Signature:
Date:
Name of reviewer:
Position:
Signature:
Date:
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