Prospective Writing To Prepare Disclosure-Ready Clinical Trial Documentation

By Adiba Kausar, Clinical Trial Disclosure Administrator, TransPerfect Life Sciences

Throughout the course of a clinical trial, numerous types of documentation are collected and transformed into regulatory submissions, publications, and reports to answer specific research questions. The configuration of clinical documentation to meet regulatory requirements and target audiences often leads to time-consuming duplicate efforts. In addition, sometimes the clinical data utility of documentation is compromised while adapting it to regulatory requirements. Therefore, prospective writing approaches are being used to plan for data transparency requirements in later stages of clinical development.