12. Running the Trial: Data Collection, Quality, Safety Reporting
After this lesson you can
- Lay out the conduct timeline from set-up to report
- Design a case report form field with its six parts
- Place range checks, logic checks, queries and source verification along the data flow
- Classify an adverse event by seriousness, causality and expectedness and name who is told
- List five design choices that prevent missing outcome data
Video coming soon
Lessons publish daily from November 17, 2026.
This lesson takes the trial into the field: the conduct timeline and roles, case report form design, visit windows and the data flow from source document to locked database. It covers quality checks, adverse event classification and reporting, and design choices that prevent missing data.
Questions and answers
Questions a learner would ask about this lesson. Think through your own answer before you open each one.
- What does a well-designed case report form field contain?
Show answer
Six parts: a name, a definition, a unit, an allowed range, the visit it belongs to, and who records it. In the fictional Oakhaven trial, the twelve-month control value is recorded from the source by the blinded outcome assessor. Every field should trace to the analysis plan, because extra fields raise errors, missingness and visit length.
- What quality checks sit between the source document and the locked database?
Show answer
Range and logic checks at entry, double entry for paper forms, queries back to the clinic answered from source, source verification on a ten percent sample, and monitoring visits. An audit trail records every change with old value, new value, who, when and why. The database is locked only when there are zero open queries, and the lock comes before unblinding.
- What is the difference between a severe and a serious adverse event?
Show answer
Severity is how intense an event is; seriousness is defined by its consequence. An event is serious if it leads to death, is life-threatening, causes hospitalization or its prolongation, persistent disability, a congenital anomaly, or another medically important event. A severe headache is not serious, while a mild event that leads to hospital admission is.
- Who is told about an adverse event, and how fast?
Show answer
Every event goes in the trial log and is reviewed at the next visit. A serious event goes to Investigator A promptly, then to the committee and the review board on the protocol clock. An event that is serious, related and unexpected goes to the regulator on an expedited basis, and a periodic summary covers all events.
- How can missing data be prevented by design?
Show answer
The lesson lists five choices: fewer and simpler visits, realistic windows, reminders and contact chains, collecting the endpoint even after a participant stops the program, and recording the reason for every missing value. Stopping the program is not leaving the trial: when Participant F stops sessions at month four, their visits continue and the twelve-month value is still collected.
Practice quiz
- Question 1A twelve-month control value is entered as 6 when the poor-control threshold is 60. What should catch it at entry?
- Question 2A logic check would flag which of these?
- Question 3The Oakhaven visit window is:
- Question 4A visit happens outside its window. What does the lesson say to do?
- Question 5An adverse event is "serious" when it:
- Question 6Which kind of event climbs the reporting ladder fastest, to the regulator on an expedited basis?
- Question 7A participant stops attending sessions at month four. The right conduct is to:
- Question 8Source verification on a ten percent sample checks:
- Question 9What does the Oakhaven safety log show?
- Question 10In the conduct timeline, which order is correct?
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Design of Clinical Studies is education only. Every lesson follows the fictional Oakhaven Adherence Trial with invented numbers; the course uses no real data and cites no real studies.