One of the characteristic features of a medical device clinical trial is its proper documentation. Legal and normative requirements regarding clinical trial documentation are laid out in Regulation no. 2017/745 and the ISO 14155:2022 standard. Clinical trial documentation may be divided into 3 main categories:
- documentation drafted prior to clinical trial commencement,
- documentation drafted during clinical trial conduct,
- documentation drafted following clinical trial completion or termination.
Clinical trial documentation, including medical records, requires authors to have a good grasp of medical terminology and knowledge of terms related to the diagnostic or therapeutic area, as well as being familiar with documentation structure. Drafting medical reports includes preparation of scientific documents, including those related to trials already completed or regulatory documents.
Pure Clinical hires highly qualified professionals with many years of experience in medical device clinical trials and medical device conformity assessments, who are familiar with the structure of documentation for medical device conformity assessments and clinical trials. Our personnel’s expertise and experience allow drafting any clinical trial-related document, as well as analysing trial results. We perform statistical analysis of the clinical data obtained and prepare the data for publication or drafting a medical device clinical assessment. We provide support for compiling and analysing data necessary for drafting a clinical trial synopsis and clinical trial report. Our experience in data analysis allows us to support the medical device manufacturer in drafting periodical safety reports and post-marketing surveillance reports.
What is Good Clinical Practice?
GCP stands for Good Clinical Practice. It is an international set of rules determining the principles for designing, performing and recording results of clinical research on human subjects.
What is the ISO 14155 standard?
The ISO 14155 standard sets forth general requirements intended to protect the rights and safety of human subjects in order to ensure the scientific conduct of clinical trials and the credibility of their results. This standard applies to medical devices and establishes the relevant good clinical practice.