Ensuring Consistency in Reporting Date and Time in Clinical Data Collection

In clinical research, accurately reporting the date and time of data collection is crucial for maintaining the integrity and reliability of findings. When the date and time of collection are reported in any domain, they should be recorded in the --DTC field (e.g., EGDTC for Date/Time of ECG). This standardization is particularly important for domains based on the Findings general observation class, such as lab tests, where the collection date is tied to when the specimen or source of the finding was captured, not necessarily when the data were recorded.

To ensure that critical timing information is consistently represented, the --DTC variable is used to denote the time of specimen collection. For example, in the LB domain, the LBDTC variable is used for all single-point blood collections or spot urine collections. For timed lab collections (e.g., 24-hour urine collections), the LBDTC variable is used for the start date/time of the collection, and LBENDTC is used for the end date/time of the collection. This approach allows both single-point and interval collections to use the same date/time variables consistently across all datasets for the Findings general observation class.

Point to always remember:

--STDTC is not used for collection dates over an interval in the Findings general observation class and is therefore blank.

By adhering to these standards, researchers can ensure that the timing of specimen collection is accurately and consistently recorded, which is essential for the validity of clinical research data. This consistency not only enhances the reliability of the findings but also facilitates better data integration and comparison across studies.

CDISC 赛仕软件 ICON Strategic Solutions ICON plc Jozef Aerts Brinda Shree Sekar Mala Bindu Sekar Muhammad Zubair Kerstin Forsberg Akshaya Nath. Geoff Low Andy Richardson Jochem Verstappen

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