Library of participant information leaflets

Shiely, F., Murphy, E., Gilles, K. et al. - Shiely, F., Murphy, E., Gilles, K. et al. Trial participants’ self-reported understanding of randomisation phrases in participation information leaflets can be high, but acceptability of some descriptions is low, especially those linked to gambling and lu - 2020
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  • Trial Management
  • Participant Information and Informed Consent
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doi: 10.1186/s13063-024-08217-3

The EXCELSIOR Patient Information Leaflet (PIL) library is an online collection of participant‑facing trial documents made available via the Trial Forge website. It brings together Participant Information Leaflets (PILs) and Informed Consent Forms (ICFs) used in randomised trials, compiled as part of a project examining how trial participants understand key concepts such as randomisation. 

The library is accessed from the Trial Forge website under resources linked to trial recruitment and data collection pathways.From the EXCELSIOR PIL Library entry, users can follow links to view or download the available PILs and ICFs collected for the EXCELSIOR work. The library is intended primarily for researchers and trial teams who write or review participant information materials for randomised trials, including investigator‑initiated studies. It can support protocol development, ethics committee submissions, and training on informed consent by providing examples of how trial information has been presented in comparable studies.

Scope and Content 

  • Real PILs and ICFs from ongoing or completed randomised trials, including some integrated PIL/ICF documents.
  • Materials drawn from trials conducted in Ireland and the United Kingdom across a range of clinical areas and trial designs.
  • Text that shows how core trial ideas (for example randomisation, reasons for randomisation, placebo, chances of allocation, rights to withdraw) are described to potential participants.
  • Concrete examples of how peer trial teams have explained complex research concepts in plain language to support informed consent.
  • Real‑world phrasings used in actual trials that help investigators to avoid “starting from scratch” when drafting participant information leaflets and consent forms
  • Can be used alongside local regulations and ethics guidance to refine wording, improve comprehensibility and check that explanations are clear and acceptable from a participant perspective.
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