The virtual regulatory team: coordinating regulatory responsibilities when the RC is one of several roles people play
Design coordination infrastructure, quality verification, and escalation paths for regulatory work distributed across staff whose primary roles are not regulatory.
The virtual regulatory team
Walk into most small-to-medium research sites and ask to meet the regulatory team. You will be introduced to one person. Sometimes two. The work, however, is performed by perhaps eight or ten — clinical research coordinators preparing their own continuing review packages, an administrative staff member maintaining the IRB log, an investigator signing forms in between patient appointments, a finance staff member tracking conflict-of-interest disclosures. The regulatory coordinator does not manage these people in any conventional sense. They cannot hire them. They cannot fire them. They cannot, in many cases, even formally evaluate their work. And yet the integrity of the regulatory record depends on the quality of what these people produce.