But times are changing. Across the industry, research sites are at various points along the path from paper to paperless. That leaves some organizations in what’s often referred to as a “hybrid process,” often replicating processes and documents both in paper and on shared drives. “It’s very redundant and it’s quite burdensome,” says Lisa Bozza Archer of Complion.
The end goal of transitioning to electronic regulatory (eRegulatory) systems and electronic signatures (eSignatures) is to have everything in one place, to have a single source of truth in order to increase efficiency and compliance. “That sounds great and exciting to people,” Lisa says, “and many sites have taken that leap.” But fear of change often inhibits progress for others. Another opportunity for simplification is to evaluate best practice templates that leading institutions are willing to share. Take advantage of opportunities to adopt templates, such as a CV, to simplify your transition toward digitizing documents.
Achieving that efficiency and allaying those fears is a matter of identifying the regulations that govern the use electronic documents and signatures, understanding eSignature adoption trends in clinical research, drawing on the experience and insight of others, and applying the best practices and lessons learned in that transition.