It is now common to convert Clinical Outcomes Assessments (COAs) originally developed for paper delivery to digital versions. However, the conversion process involves many details and missteps along the way can negatively impact study timelines and costs.
COAs are scientific material that must be used as prescribed by the COA developer in order to ensure the validity of the data collected. For this reason, their implementation in electronic format must follow several validation steps and adhere to both generic guidance for all eCOAs and specific requirements related to the particular assessment.
Mapi Research Trust’s strategy for eCOA implementation integrates input from various stakeholders in the eCOA industry to streamline the certification process. Additionally, our eBooklets provide COA-specific guidelines for electronic implementation to minimize the number of screenshot reviews required and, ultimately, to help the industry in standardizing the implementation process for individual eCOAs.
Digitizing Clinical Outcomes Assessments (COAs): A streamlined approach to approval