This document provides an overview of plain language summaries and their importance in clinical trials. A plain language summary translates technical trial results into easy-to-understand language for participants. It generally includes: thanking participants for their involvement, an overview of the trial, and a discussion of results reflecting the clinical study report. The EU will require plain language summaries be made publicly available within 1 year of a trial's completion. Sharing results with participants respects their contribution and perspective. Sponsors aim to go above regulatory requirements by working with investigators to distribute summaries and obtain necessary approvals.

1. Investigator Educational Material
Returning Plain Language Summary Results

2. Overview of Plain Language Summary
• “Translates” the technical results of clinical trials into easy-to-
understand language
• Scientifically accurate and non-promotional
• IALS Level 2-3 / US-equivalent 6th – 8th grade level
• Main elements:
1. “Thank You” to participants and recognition of their participation in the
study
2. An overview of the clinical trial based on information contained in clinical
study protocol.
3. A discussion of study results directly reflecting technical findings in the
clinical study report
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3. Potential Content for Plain Language Summary
• Thank you to the study participants
• If maintaining consistency with clinical study report & Annex V of the EU Clinical Trial
Regulation
• Clinical trial identification
• Name/contact of sponsor
• General information about the trial
• Population of subjects
• Investigational medicinal products used
• Description of Adverse reactions and their frequency
• Overall results of the clinical trials
• Comments on the outcome of the clinical trial
• Indication if follow-up trials are foreseen
• Indication where additional information can be found
If sponsor has an example of a plain language summary, a picture of this could be
included as an example for the Investigators
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4. EU Regulation No 536/2014 (Article 37)
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• Regulation to go into effect 2018
• Requires plain language summaries to be made publicly in the EU database for all
clinical trials in health volunteers and patient population, Phase 1 to Phase 4, conducted
in at least one site in the EU.
• Release of plain language summaries 1 year post Last Patient Last Visit (LPLV) for adult
studies and, ideally, 6 months post LPLV for pediatric studies. Further clarification
needed from EU Guidance on timing for pediatric studies.

5. Importance of Sharing Results
Patient Perspective:
• 95% of trial participants have positive experiences overall, but many feel let down at the end of
the study.1
o “You give them your last couple of blood draws and that’s it. You’re done with it.
Everything stops. You get cut off.”2
o “You are extremely well informed, but once you come off the trial there is not one letter.
Nothing...”3
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Investigator and Site Staff Perspective:
• 49/50 support overall approach in qualitative evaluations, noting ethical responsibility and
patient interest.7
1. CISCRP. 2013. Perceptions and Insights Study.
2. CISCRP. 2012. Patient Experience Interviews.
3. Ramers-Verhoeven et al., 2014, as cited in IOM report
4. Shalowitz, D. and Miller, F. 2008. PLoS Medicine. 5:714-72
5. Kost, R., et al. 2013. N Engl J Med. 369:2179-2181.
6. Sood et al. 2009. Mayo Clinic Proceedings. 84(3):243-247.
7. Getz K, et al. 2012. Expert Review of Clinical Pharmacology. 5: 149-56.

6. Sponsor Vision
If there is a sponsor vision or mission statement about why the sponsor
wants to voluntarily go above and beyond the regulation this should be
included and shared with the investigators.
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7. 6
 Investigator involvement
in the distribution of the
plain language summary
to patients will be outlined
in the site contract
 Sponsor will work with
site to confirm if the
summary needs to be
submitted to the IRB/EC
for approval
 Informed consent form
will have information
regarding timing and
distribution of summary to
patient
 The initial submission
package to the IRB/EC
will also contain a copy of
the Thank You letter.
Study Start Up
 At the last visit the Thank
You letter should be
provide to the patient
End of Study
Patient Last Visit
 Sponsor will send to the
site hard copies of the
plain language summary.
 For sites that require
IRB/EC approval site
should submit the
document
Submissions to Sites
Insert est. timeframe
 Site to share the printed
summary to the
participants
Delivery to Patients
 Sponsor will follow-up
with site after delivery of
plain language summary
to confirm materials were
received, distributed to
patients, and address and
concerns.
Follow-up
Investigator Involvement
Slide should be updated based on sponsor Process