Whitepaper | Digitizing COAs: A streamlined approach to approval

In all aspects of life, paper copies are giving way to electronic versions of documents. Clinical research is no exception as there is an ongoing push to capture trial data electronically to improve both the participant experience and data quality.

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.

Success factors in COA digitization

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.

Read our whitepaper to learn more about:

• COA copyrights and licenses
• Keys to achieve equivalency
• The screenshot review process
• The root causes of digitization issues
• Success factors in eCOA certification