When a Site Is Failing

Part of Clinical Project Management (PM) Training: Site Oversight Without Doing Their Job.

About 2 minutes. Free, in your language, no account needed.

Diagnose before you intervene

Underperformance has causes, and the response depends entirely on which one it is.

Capacity. The coordinator has too many trials. More reminders make it worse.

Comprehension. The staff do not understand a procedure or a form. Retraining helps.

Access. The population is not reaching the site. Referral support or advertising helps; nothing else does.

Engagement. The PI has moved on. This one is rarely fixable and is the one most often mistaken for the other three.

Asking the site directly, without blame, usually gets an honest answer. The coordinator knows which of these it is.

Escalate in steps, and record each one

A documented conversation, then a written action plan with dates, then a for-cause monitoring visit, then a formal letter, then closure. Skipping steps leaves you unable to demonstrate that you gave the site a fair chance, and an abrupt closure can become a dispute.

Every step needs a date and an outcome in the file. Oversight that is not recorded did not happen as far as an inspector is concerned.

Closing a site

Closing a non-performing site is a legitimate act, not an admission of failure. The cost of keeping it open is monitoring attention, drug sitting on a shelf, and an ongoing obligation for any participants already enrolled.

Participants already enrolled must be transferred or followed to an appropriate endpoint. Their safety and their data do not end because the site did.

Do it early

A site that has not enrolled in six months, after an action plan, will not enroll in month seven. The decision is usually obvious months before it is taken, and the delay is almost always about not wanting to have the conversation.