Author: Monique Al
Last saved by: Levison, S. (Solange)
Company: Rijksoverheid

Template recruitment procedure and first act of recruitment, version Netherlands 1.0, dd 11 November 2021

Recruitment procedure and first act of recruitment.

1 | How will potential participants be identified? (e.g. publicising the trial or via existing patient lists)
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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; copies of the advertising material, including any printed materials, and audio or visual recordings, should be uploaded in part II application CTIS)
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3 | Who will be approaching potential participants (or their legal representative) and who will be obtaining informed consent? (Describe the professional role and whether there is a prior clinical relationship with potential participants and how are the interests of the potential participants safeguarded)
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4 | How long will potential participants (or their legal representative) be given to decide whether to participate?
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5 | How will be ensured 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 and how this understanding is verified)
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6 | What arrangements are in place to obtain informed consent from potential participants (or their legal representative) who do not speak the national language (if applicable)?
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7 | 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 the clinical trial application  (e.g specific recruitment and informed consent procedures in an emergency clinical trial )
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8 | Please provide a clear indication of what the first act of recruitment is to recruit potential participants for the clinical trial (advertisement, contact between investigator and potential participant, subject information letter). (If described in protocol, please refer to protocol section; see also CTR, annex I, section K59)
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