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Recruitment and Informed consent procedure
template
How to use this document
It is not mandatory to use this template for describing recruitment arrangements
(Annex I K.59) and/or informed consent procedure (Annex I. L) but where this template
is not used for this purpose, all the relevant information below should be included in
the protocol as a minimum, according to Annex I (D.17.z). This is notwithstanding
additional appropriate information also being included in the protocol.
Sections which are not appropriate should either be deleted or marked as Not
Appropriate / NA.
This template has been endorsed by the EU Clinical Trials Coordination and Advisory
Group (CTAG) to comply with Regulation (EU) No. 536/2014 Clinical Trials on
Medicinal Products for Human Use.
EU trial number
Title of clinical trial
1. All clinical trials (This section should be completed for all trials)
1.1
How will potential participants be identified? (e.g. publicising the trial or via existing
patient lists)
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1.2
What resources will be used for recruitment? (Describe the format of the resources,
e.g. paper or electronic and how these will be presented to potential participants e.g. via the post, in
the clinic, through social media or on the radio)
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1.3
Will identification of potential participants involve access to identifiable
information?
If yes, describe what measures will be in place to confirm that access to
this information will be lawful (in accordance with Member State requirements).
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1.4
Who will be approaching potential participants and who will be obtaining
informed consent? (Describe the professional role and whether there is a prior clinical
relationship with potential participants)
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2. Clinical trials which will recruit incapacitated adults
Incapacitated adults may be recruited into clinical trials only where consent has been obtained from a
legally designated representative and data of a comparable validity cannot be obtained in clinical trials
involving participants who are competent to give informed consent. Where potential participants do lack
capacity to consent, arrangements should be in place to involve them as much as possible in the
decision to participate in the clinical trial.
2.1
Provide justification for recruiting incapacitated adults (This should include details of
the nature of the condition which has caused the person to be incapacitated and the relevance of this
condition to the clinical trial)
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2.2
Who will assess and confirm whether a potential participant has the capacity
to consent?
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1.5
When will free and informed consent be obtained? (Describe when and where
informed consent will be obtained and how privacy will be ensured)
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1.6
How long will potential participants (or their legal representative) be given
to decide whether to participate?
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1.7
How will it be assured that potential participants (or their legal
representative) have understood the information and that consent is
informed? (This should include how the informational needs of individuals will be identified and
addressed)
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1.8
What arrangements are in place to obtain informed consent from potential
participants (or their legal representative) who do not speak the national
language?
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1.9
How will it be ensured that participants can withdraw their consent at any
point? (This should include how any potential consequences of consent withdrawal will be dealt
with)
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1.10
Please provide any further information, in relation to the procedure for
recruitment and informed consent for the clinical trial, which has not been
provided elsewhere in this document. (It is recommended that you refer to national
guidance to ensure that all required information has been provided)
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1.11
In case this form is used also to describe recruitment arrangements
(Annex I K59), please provide a clear indication of what the first act of
recruitment is
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2.3
Where capacity to consent will fluctuate or will be borderline, how will
potential participants be involved in the decision to participate in the trial?
(This should include how information will be tailored to ensure participants (potential and existing) are
able to understand the information and also how participants who regain capacity will be consented to
continue in the trial)
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2.4
How will a legal representative be identified? (This should include which roles could act
as legal representative for this trial)
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3. For clinical trials which will involve minors
Minors may be recruited into clinical trials only where consent has been obtained from a legally
designated representative and where the clinical trial is such that it can only be carried out on minors.
The minor should take part in the informed consent procedure as much as would be appropriate based
on age and mental maturity. Where it would be appropriate, please specify any different arrangements
for different age ranges.
3.1
Provide justification for recruiting minors
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3.2
How will potential participants be involved in the decision to participate in the
trial? (Describe arrangements for obtaining and recording assent, including who will be obtaining
consent and details of their training and experience with children)
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3.3
How will a legal representative be identified? (This should include which roles could act
as legal representative for this trial)
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3.3
How will participants be consented to continue in the trial when they reach
the age of legal competence?
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4. Clinical trials where consent witnessed by an impartial witness will
likely be used.
Where a participant is unable to write, consent may be given and recorded through appropriate
alternative means in the presence of at least one impartial witness. The witness is required to sign and
date the informed consent document.
4.1
Why is it expected that an impartial witness might be required?
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4.2
How will an impartial witness be identified?
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4.3
How will it be known that the potential participant gives their informed
consent?
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5. Clinical trials in an emergency situation
Information on the clinical trial may be given and informed consent may be obtained after the decision
to include the participant in the clinical trial. This is where the decision is taken at the time of the first
intervention in accordance with the protocol and, due to the urgency of the situation, the person is
unable to give consent, nor can a legal representative be identified.
5.1
Describe why it would not be possible to obtain consent from potential
participants or a legal representative prior to recruiting into the clinical trial.
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5.2
What arrangements will be in place to obtain informed consent from the
participant or from a legal representative, whichever can be obtained
soonest? (Where a legal representative is expected to be required due to the participant not having
capacity to consent, please also complete section 2 of this document)
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5.3
How will it be ensured that a potential participant has not expressed any
previous objection to participate in the clinical trial?
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6. For ‘cluster’ clinical trials
Informed consent may be obtained by simplified means where this does not contradict national law, the
methodology of the trial requires the randomisation of groups rather than individuals, the investigative
medicinal product is being used in accordance with the terms of the marketing authorisation and there
are no interventions other than standard treatment. Clear justification for simplified consent should also
be included in the protocol.
6.1
Describe how simplified informed consent will be obtained?
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