Clinical Study Templates
Save valuable time and money, while increasing efficiency and productivity, by avoiding repetitive and labor-intensive manual work as well as frustrating formatting errors, with high-quality templates for clinical evaluation plans (CEPs) and reports (CERs) for EU MDR 2017/745 submissions, and clinical study protocols (CSPs) and reports (CSRs) that support 510k Food and Drug Administration (FDA) submissions.
Clinical Document Templates that…
- follow the EU MDR 2017/745-recommended MDCG 2020-6 guidelines
- follow the FDA-recommended ICH E3 and E6 guidelines
- contain extensive instructions and practical example text
- are easy to use, review and edit
- have an appealing layout that is robust and resilient to formatting errors
The clinical evaluation and clinical study templates were developed by Clinical Study Templates for Microsoft® Word with both the author and reviewer(s) in mind.
Learn more about the clinical evaluation and the clinical study templates.
The integration of automated formatting features through the customized Styles gallery, and the exceptional ease of using these clinical study templates allow experienced authors to quickly draft clinical documents from beginning to end, and offer novice writers clear guidance (including explanations and example text) to create clinical-grade, high-quality documents that ensure consistency across CERs, CEPs, CSRs and CSPs.
Moreover, their robust design makes these templates resilient to notorious formatting issues (e.g., text and figures jumping all over the place, black boxes that cover heading numbers, misalignment of text, mismatching font types, etc.).