Clinical Trial Transparency training
During the three sessions, Maxer consultants presented the legal framework and the governing principles that are the basis of the clinical trial transparency, and the procedures of anonymization and redaction that EMA indicates for the submission dossier and the synopsis from the Clinical Study Report.
Maxer consultants devoted ample space to the drafting of the layperson summaries, with insights on the writing techniques and the measurement of the readability indices.
Two practical sessions dealt with the full dataset uploading procedure on the EudraCT platform.
Overall, the training program addressed all the issues related to Clinical Trial Transparency, offering a comprehensive view of the matter and by providing the participants with the tools they need to manage it