One key attribute for good study documentation is that the data are contemporaneous, which refers...

Contemporaneous data means that data entries are made at the time of the event or as soon as possible after the event occurs. This practice ensures that the recorded data accurately reflect the participant’s condition and study procedures, minimizing recall bias and errors. Maintaining contemporaneous records is a fundamental requirement for ensuring the accuracy and reliability of clinical trial data.

GCP guidelines specify that data should be recorded as close to the time of the event as possible to ensure accuracy and reliability.

"Data must be contemporaneously recorded, meaning they are documented at the time of the occurrence to accurately reflect the study conduct."

Objectives:

Ensure accurate and real-time data capture.

Maintain data integrity by minimizing recall bias.