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Protocol Synopsis

Quickly understand why and how research is being done

Efficiently develop a clear and concise plain language protocol synopsis for every clinical trial, to help all stakeholders quickly understand why and how the research is being done—from patients and the public to study site staff, ethics committees, and regulatory reviewers.

The Problem

Study staff are often not equipped with plain language material.

Patients and the public often do not find clear and concise information about specific clinical trials when they search for research that is relevant to them. Study staff are often not equipped with sponsor-approved plain language tools to facilitate conversations with patients about a clinical trial. This represents a missed opportunity to appropriately engage and inform patients from the start of their clinical trial experience.

This critical issue, along with emerging requirements and recommendations relevant to the European Union’s Clinical Trial Regulation (EU) No 536/2014 (EU CTR), are compelling researchers to develop a standardized and efficient approach to providing a plain language protocol synopsis for each of their clinical trials.

CISCRP's Solution

CISCRP will work from your clinical study protocol to create an engaging plain language summary of the protocol synopsis. Following CISCRP’s widely recognized Health Communication processes and practices, our medical writers, plain language editors, and graphic designers will efficiently collaborate with your team to create an engaging protocol synopsis.

For a protocol synopsis submitted under the EU CTR as part of your initial application for a clinical trial, we will align with current recommendations and guidance, including the nine recommended elements and two-page limit.

The plain language protocol synopsis will help any stakeholder quickly understand why and how the trial will be done, without the complex details from the full protocol. Your team can leverage this content across other clinical research documents and provide it to study sites to facilitate conversations with patients.

  • Skilled team of medical writers, plain language editors, and graphic designers

  • Two-Page Limit

  • Engaging patients from the start of their clinical trial experience

Start Your Project

Drugviu

Click on the resources listed below to download the full versions of Drugviu’s materials. 

Pandemic Response Network Flyer: English

Red de Respuesta a una Pandemia: Español

Peer Plus

Click on the resources listed below to download the full versions of these materials. 

Peer Plus: Mission and Capabilities

Latino Union of Chicago

Click on the resources listed below to download the full Latino Union of Chicago Annual Report. 

 

Advocate Aurora Health

Click on the resources listed below to download the full versions of Advocate’s materials. 

  • Dominantly Inherited Alzheimer’s Network Trial Unit 

Dominantly Inherited Alzheimer’s Disease Brochure
Expanded Registry Flyer (English)

Enfermedad de Alzheimer de herencia dominante
Expanded Registry Flyer (Spanish)

  • Clarity AD Clinical Study Information

Forgetting the Little Things
Concerned About Memory Loss?

   

Allergy & Asthma Network

Click on the resources listed below to download the full versions of the Allergy & Asthma Network’s materials. 
 

Institute for Population and Precision Health (IPPH)

Click on the resources listed below to download the full versions of IPPH’s materials. 
 

Einstein Healthcare Network

Click on the resources listed below to learn more about Einsteing Healthcare Network’s resources. 

TREND Community

Click on the resources listed below to download the full versions of the TREND Community’s materials. 

 

Community Voice Report July 2020: COVID-19 Positive

 

Community Voice Report August 2020: Pericarditis

Fox Chase Cancer Center - Temple Health

Click on the resources listed below to download the full versions of the Fox Chase Cancer Center’s materials. 
Be the Breakthrough: Understanding Clinical Trials

Allergy & Asthma Network

Click on the resources listed below to download the full versions of the Allergy & Asthma Network’s materials. 
 

Lung Cancer Initiative of North Carolina

Click on the resources listed below to view the full versions of LCI’s materials. 

Lung Cancer Risk Assessment Handout

PRA Health Sciences

Click on the resources listed below to view the full versions of PRA’s materials. 

Duke Health

Click on the resources listed below to view the full versions of Duke’s materials. 

Visit Discover Duke Research on Facebook

Download the handout below in English or Spanish

North Carolina Clinical Research

Visit North Carolina Clinical Research’s website 

Missy Hansen

Missy Hansen MSN, APRN, CPNP, CPHON, joined ICON in 2019 as a pediatric strategy liaison. She has 25+ years of experience as a pediatric nurse practitioner, including 17+ years in pediatric hematology/oncology at Children’s Minnesota, the largest hematology/oncology service line in the region, providing care for infants through young adults diagnosed with hematologic and/or oncology conditions. Ms. Hansen gained expertise working in inpatient, outpatient, and urgent care type settings. Ms. Hansen has in-depth experience working with the Children’s Oncology Group—the largest consortium with the most open pediatric studies around the world. She also has experience working with other consortia that conduct trials for pediatric to young adult patients.