Enrollment Reports Sponsors Don't Have to Question

Most sites send enrollment numbers to sponsors every week. Far fewer send enrollment reports that actually change how the sponsor treats them. The difference isn't effort — it's whether the numbers explain themselves well enough that a CRA or study manager can act without calling you.

What sponsors are actually reading for

A study manager looking at your weekly report is answering three questions: Are you going to hit your target? If not, what's blocking you? And can I trust these numbers enough to forecast with them?

Most site reports answer only the first, and poorly. A single line that reads "3 screened, 1 randomized" gives the sponsor no idea whether you have a pipeline problem, a qualification problem, or a scheduling backlog. The next thing that happens is an email asking for clarification, and you spend 40 minutes reconstructing what happened.

Report the funnel, not the endpoint

The fix is reporting stage-by-stage counts rather than outcomes. At minimum:

• New referrals or inquiries received
• Pre-screens attempted and completed
• Pre-screen passes
• Consents scheduled
• Consents completed
• Screened
• Screen failures, with reasons
• Randomized or enrolled

When all eight numbers are visible, the sponsor diagnoses the problem themselves. A site with 40 inquiries and 6 completed pre-screens has a contact problem. A site with 20 completed pre-screens and 2 passes has an eligibility problem, and that's often a protocol conversation rather than a site performance conversation. Sites commonly find that showing the full funnel shifts the discussion away from "why are you behind" toward "what can we change."

Make screen failure reasons specific

"Did not meet inclusion criteria" is useless. Record and report the specific criterion: HbA1c out of range, washout period not feasible, concurrent medication exclusion, imaging finding. Sponsors aggregate these across sites, and specific reasons are what trigger protocol amendments. Vague reasons get filed and forgotten.

Keep the categories stable. If you change how you bucket failures mid-study, your trend lines become meaningless and the sponsor notices.

Lock your definitions before the first report

The fastest way to lose credibility is to have your numbers shift retroactively. Decide at study startup:

1. When does a referral count? At inquiry receipt, or after first contact attempt?
2. What counts as a completed pre-screen? Full questionnaire, or any substantive conversation?
3. What's the data cutoff? Pick a day and hour and hold to it every week.
4. Who reconciles against EDC? Someone should be comparing your report numbers to what's in the system monthly.

Write these definitions down and put them in a footnote on the report itself. When a new coordinator starts pulling the numbers, the definitions travel with the document.

Add context in two sentences, not two pages

Under the table, write a short note on what changed and what you're doing. "Three consents pushed to next week due to PI vacation; two rescheduled, one withdrew." That's it. Sponsors read short notes and skip long ones.

Flag problems early, in writing

If you're going to miss a milestone, say so in the report before the sponsor asks. A site that forecasts its own shortfall two weeks out reads as in control. A site that reports on target until the deadline passes reads as either disorganized or evasive, and both are expensive reputations to carry into the next study award.