Institutional restructuring: when your reporting lines, IRB relationships, or organizational context changes
Learn how to evaluate the regulatory operations impact of mergers, acquisitions, and reorganizations, design a reconciliation plan that preserves records integrity per ICH E6(R3) Appendix C, and uphold the continuity-of-compliance principle for every active study.
Institutional restructuring: when your reporting lines, IRB relationships, or organizational context changes
There is a particular phone call that changes everything. The dean's office wants a meeting. The health system has signed a letter of intent. The department is being absorbed into a new division. By the time the announcement reaches the research office, the deal is already done — and your job, as the person responsible for regulatory operations, is to keep eighteen active studies in continuous compliance through a transition you did not design.
I have lived through several of these. The pattern is reliable. Leadership focuses on org charts, branding, and cost synergies. The research operation is treated as a back-office function that will "figure itself out." It will not. Restructuring touches every regulatory relationship, every document set, every approval chain, and every communication pathway your operation depends on — and the principle that must guide you through it is unromantic but absolute: every active study maintains uninterrupted compliance, regardless of what happens to the organization around it.
What you will learn
By the end of this lesson, you will be able to: