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Sunday · Week Ahead

Five questions to ask on Sunday about any data milestone week

A ten-minute Sunday routine that tells you whether this week's lock, dry run or transfer is on track, and what to do first on Monday.

Published
Reading time
about 3 min
Series
The Readiness Brief

The short version

  • A milestone week goes wrong long before the milestone, usually on a decision or a dependency nobody owned.
  • Five questions, answered on Sunday in about ten minutes, expose most of those problems while there is still time to act.
  • Write the answers down where the team can see them. A question you cannot answer is your first Monday task.

Why Sunday, and why only five

Welcome to The Readiness Brief. Every day at 10:00 Eastern there is a new one, and each weekday has its own format: Monday decodes a standard, Tuesday is about database lock, Wednesday looks through a reviewer's eyes, Thursday does capacity arithmetic, Friday dissects one failure, Saturday is a longer read and Sunday sets up the week. This is the first Sunday brief.

Most milestone weeks are decided by things that are already true on Sunday: a decision is still open, a vendor transfer is late, a reviewer is on leave. What changes during the week is only how much room is left to deal with them. Good practice guidance makes the same point in more formal language: ICH E6(R3) asks sponsors to identify the factors that are critical to quality and to manage risks to them in proportion to their importance, rather than checking everything equally [1]. Five questions are enough to find the critical few for one week.

The five questions

1. What is the fixed date, and what is its latest acceptable date? The fixed date is the lock, the data cut or the transfer. The latest acceptable date is the last day each input can arrive without moving the fixed date. Work backwards: if outputs need two days of QC and one day of statistical review, the final datasets must exist three working days before the deadline. Anything that lands later moves the date, or something gets skipped.

2. Which decisions are still open, and who owns each one? Population definitions, protocol deviation classifications, handling of a late external dataset. An open decision is a fixed wait: adding programmers does not make a decision arrive sooner [2]. Each one needs a named owner and a date, and the date has to be earlier than the latest acceptable date from question 1.

3. Which dependencies sit outside the team? Central lab, ECG and PK vendor transfers, IRT data, coding of adverse events and medications. Ask when each last arrived, whether it passed its checks, and when the next one is due. A dependency you cannot see is the one that surprises you on Thursday.

4. How much QC and review does this week really need? Count the outputs that change this week and how they will be checked: independent programming, peer review or a spot check. Then compare that with the hours people actually have, after meetings and other studies. Queues grow quickly when a team runs close to full capacity, so a week planned at 100 percent has no room for the one surprise it will get [3].

5. What would you escalate today, and to whom? If any answer above says the date is at risk, the useful escalation is early and specific: the item, the date it puts at risk, two or three options and the decision you need. Saying it on Sunday night costs an email. Saying it on Friday costs the milestone.

A synthetic example

The ZEPHYR-101 study (fictional) has a database lock on Friday. On Sunday the lead programmer finds that the per-protocol population rules have not been signed off, that the last ECG transfer failed a reconciliation check, and that the independent QC programmer is shared with another study until Wednesday. None of these is a crisis yet. The Monday plan becomes: ask the statistician for population sign-off by Tuesday noon, ask data management to chase the ECG vendor with a Wednesday deadline, and move QC of the highest-risk outputs to Monday and Tuesday when the programmer is free. One email to the study lead lists the three items and the dates they protect.

Do this today

  1. Write down this week's fixed date and work back to the latest acceptable date for each input.
  2. List every open decision with an owner and a close-by date. Anything without an owner is Monday's first message.
  3. Check the last arrival and the next due date of every external data transfer the milestone depends on.

Check yourself

One question

Your lock is on Friday and three population decisions are still open. Which question tells you most about whether Friday is still realistic?

Show the answer

Answer 2. Staff numbers and finding counts matter, but an open decision is a fixed wait that extra people cannot shorten. Working back from Friday to the latest date each decision can close shows whether the plan still holds and who needs to hear about it on Monday.

Apply it

Turn it into a plan

The brief says what to check. The Navigator and the Handbook turn it into dated, owned actions for your milestone, in your browser, with no study data.

Sources

References

  1. ICH. E6(R3) Guideline for Good Clinical Practice. International Council for Harmonisation; 2025. www.ich.org ↗
  2. Goldratt EM. Critical Chain. North River Press; 1997.
  3. Reinertsen DG. The Principles of Product Development Flow: Second Generation Lean Product Development. Celeritas Publishing; 2009.

Standards and guidance change. Confirm the version in force for your study, sponsor and region before relying on any reference. Examples are synthetic and illustrative. This brief is generalized professional guidance, not regulatory advice.

Next brief · Monday 10:00 ET · Standards Decoded

The one-row-per-parameter dataset that decides whether your submission gets past the gate.

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