A clinical research associate reviews the entry during a monitoring visit, comparing it against the source worksheet. A data manager at the CRO runs it through programmatic edit checks. A medical monitor flags it as a potential safety signal. A biostatistician includes it in a blood pressure trend analysis across 200 participants. A regulatory reviewer at the FDA reads the summary table in a New Drug Application and notes the incidence of treatment-emergent hypertension.

Twelve people -- or more -- will handle that number before it influences a regulatory decision about whether a drug reaches the market. But only one of them was in the room when the measurement happened. Only one saw the participant's arm position, heard the mention of the stairs, noticed that the cuff size was borderline between regular and large. Only one had direct knowledge of the original clinical observation.

That person was the coordinator.

A clinical research associate reviews the entry during a monitoring visit, comparing it against the source worksheet. A data manager at the CRO runs it through programmatic edit checks. A medical monitor flags it as a potential safety signal. A biostatistician includes it in a blood pressure trend analysis across 200 participants. A regulatory reviewer at the FDA reads the summary table in a New Drug Application and notes the incidence of treatment-emergent hypertension.

Twelve people -- or more -- will handle that number before it influences a regulatory decision about whether a drug reaches the market. But only one of them was in the room when the measurement happened. Only one saw the participant's arm position, heard the mention of the stairs, noticed that the cuff size was borderline between regular and large. Only one had direct knowledge of the original clinical observation.

That person was the coordinator.