None of this lives in the SOP. None of it lives in the trial master file. It lives in the head of the person who is now in the parking lot, and by Monday morning it is gone.

I have spent considerable time watching regulatory functions try to recover from this kind of loss, and the pattern is depressingly consistent. The replacement coordinator is competent — sometimes more competent on paper than the predecessor — and yet the function visibly degrades for six to eighteen months. Submissions take longer. Avoidable IRB stipulations multiply. Sponsor calls escalate where they used to resolve. The trial master file itself remains compliant; the regulatory records are accurate. What has been lost is something else entirely: the operational intelligence that converts compliant records into efficient operations.

Knowledge management — done seriously, not as an afterthought — is the discipline that prevents this. It is the difference between a regulatory function that degrades with every departure and one that, remarkably, improves with every transition because each person who passes through leaves more captured behind than they took with them.

None of this lives in the SOP. None of it lives in the trial master file. It lives in the head of the person who is now in the parking lot, and by Monday morning it is gone.

I have spent considerable time watching regulatory functions try to recover from this kind of loss, and the pattern is depressingly consistent. The replacement coordinator is competent — sometimes more competent on paper than the predecessor — and yet the function visibly degrades for six to eighteen months. Submissions take longer. Avoidable IRB stipulations multiply. Sponsor calls escalate where they used to resolve. The trial master file itself remains compliant; the regulatory records are accurate. What has been lost is something else entirely: the operational intelligence that converts compliant records into efficient operations.

Knowledge management — done seriously, not as an afterthought — is the discipline that prevents this. It is the difference between a regulatory function that degrades with every departure and one that, remarkably, improves with every transition because each person who passes through leaves more captured behind than they took with them.