Database Design and Development Flashcards

What is the purpose of an 'audit trail' in a validated clinical database?

Answer: To maintain a time-stamped, user-attributed record of all data creation and modifications

An audit trail records every data entry, change, and deletion with the user ID, date, time, and reason, providing full traceability required by GCP and 21 CFR Part 11.

In SDTM, what is a 'domain'?

Answer: A standardized dataset containing related observations of a specific type (e.g., demographics, adverse events)

An SDTM domain is a dataset containing related observations organized by topic, such as DM (Demographics), AE (Adverse Events), or LB (Laboratory), with standardized variable names.

What is the purpose of a 'data transfer agreement' (DTA) in multi-site clinical trials?

Answer: To define the format, frequency, and responsibility for transferring data between systems or organizations

A DTA specifies technical specifications, timelines, formats, security requirements, and responsibilities for transferring clinical data between sites, vendors, or sponsors.

Which term describes the process of assigning a unique identifier to each subject in a clinical trial database?

Answer: Subject identification coding

Subject identification coding assigns a unique, often alphanumeric, code to each participant, protecting anonymity while allowing data linkage across all study records.

What is a 'SAS transport file' (.xpt) used for in clinical data submissions?

Answer: A standardized file format required by the FDA for submitting SDTM and ADaM datasets

The SAS transport (.xpt) format is the FDA-required file format for SDTM and ADaM dataset submissions in electronic New Drug Applications (eNDAs) and Biologics License Applications (eBLAs).

What is the purpose of a 'define.xml' document in regulatory submissions?

Answer: To provide metadata describing the datasets, variables, value lists, and code lists in the submission package

The define.xml is a CDISC-standard metadata file that describes all datasets, variables, their definitions, controlled terminology, and relationships within a regulatory submission package.