Connecting with patients throughout the clinical trial lifecycle
Engaging with patients and caregivers is a key part of clinical trial recruitment and retainment. Plain language documents can not only meet regulatory requirements but can also increase patient engagement by encouraging health literacy about clinical trials. Studies have shown that higher health literacy levels relate to increased willingness to enroll in clinical trials. From informed consent forms to plain language summaries, these documents ensure that the public is informed about clinical studies, and they understand the value of their contributions to science and public health.
Types of Plain Language Documents
- Plain language protocol synopses (PLPS)
- Informed consent forms (ICF)
- Plain language summaries of results (PLS)
- gov Brief Title and Description as well as other regulatory sites
- Individual return of results
Customizable plain language templates
Certara’s customizable plain language templates incorporate public health communication best practices to create easy to understand documents. Some of the highlights include:
- Plain language best practices and lean writing techniques based on the research of such groups as Multi-Regional Clinical Trials (MRCT) and the NIH.
- Infographics, information chunking, use of white space, and call out boxes to make documents visually appealing.
- Use of International English to make documents easy to translate and understand.
- Structuring documents to meet accessibility standards for people living with visual impairment.
- Numeracy literacy as well as health literacy principals to clearly communicate complex concepts.
Meeting Regulatory Requirements
Starting January 31st, 2023, the European Medicines Agency (EMA) requires PLS for clinical trials. The UK has also required PLS since 2022. Certara’s PLS templates meet all requirements set out in Annex V of EU Regulation No 536/2014.
Certara also creates PLPS for clinical trial applications as recommended by the EMA. EMA regulations require that review committees include members of the lay public. PLPS help the lay members of review committees easily understand the clinical trial protocol and inform their decisions.
Certara monitors regulatory intelligence and takes part in international working groups to ensure high quality plain language documents that meet regulatory requirements.
Featured Experts
Laura Sheppard, MBA, MA
Senior Director, Global Submissions and Plain Language Summary Lead
Lee Holland, PharmD, MPH
Associate Director – Regulatory Services Management – PLS
Laura Sheppard, MBA, MA
Senior Director, Global Submissions and Plain Language Summary Lead
Lee Holland, PharmD, MPH
Associate Director – Regulatory Services Management – PLS
Ms. Sheppard is a senior director of global submissions and medical writer with experience in document quality control, project management, and clinical transparency and disclosure in both contract research organizations and pharmaceutical environments. She has 20 years of experience in translational science, clinical development, and clinical operations, including 15 years in medical writing and regulatory strategy experience with global marketing applications for both biologics and small molecules, as well as for Investigational New Drug (IND) and Clinical Trial Authorization (CTA) applications.
Lee Holland is the Associate Director, Regulatory Services Management of Plain Language Summaries at Certara. She has a decade of research and medical writing experience and has overseen the authoring of over 200 plain language documents.
Ms. Sheppard is a senior director of global submissions and medical writer with experience in document quality control, project management, and clinical transparency and disclosure in both contract research organizations and pharmaceutical environments. She has 20 years of experience in translational science, clinical development, and clinical operations, including 15 years in medical writing and regulatory strategy experience with global marketing applications for both biologics and small molecules, as well as for Investigational New Drug (IND) and Clinical Trial Authorization (CTA) applications.
Lee Holland is the Associate Director, Regulatory Services Management of Plain Language Summaries at Certara. She has a decade of research and medical writing experience and has overseen the authoring of over 200 plain language documents.