0. Investigator Educational Material
Returning Plain Language Summary Results

1. 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:
“Thank You” to participants and recognition of their participation in the study
An overview of the clinical trial based on information contained in clinical study protocol.
A discussion of study results directly reflecting technical findings in the clinical study report

2. 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

3. EU Regulation No 536/2014 (Article 37)
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.

4. 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
“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
“You are extremely well informed, but once you come off the trial there is not one letter. Nothing...”3
Investigator and Site Staff Perspective:
49/50 support overall approach in qualitative evaluations, noting ethical responsibility and patient interest.7
1. CISCRP Perceptions and Insights Study.
2. CISCRP Patient Experience Interviews.
3. Ramers-Verhoeven et al., 2014, as cited in IOM report
4. Shalowitz, D. and Miller, F PLoS Medicine. 5:714-72
5. Kost, R., et al N Engl J Med. 369:
6. Sood et al Mayo Clinic Proceedings. 84(3):
7. Getz K, et al Expert Review of Clinical Pharmacology. 5:

5. 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.

6. Investigator Involvement Slide should be updated based on sponsor Process
Study Start Up
End of Study
Patient Last Visit
Submissions to Sites
Insert est. timeframe
Delivery to Patients
Follow-up
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.
At the last visit the Thank You letter should be provide to the patient
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
Site to share the printed summary to the participants
Sponsor will follow-up with site after delivery of plain language summary to confirm materials were received, distributed to patients, and address and concerns.