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.
