Communication & Documentation Flashcards

Which statistical term should a researcher correctly report when describing the spread of continuous data in a journal article?

Answer: Mean with standard deviation or median with interquartile range depending on distribution

For normally distributed data, mean ± SD is appropriate; for skewed data, median with IQR better represents the central tendency and spread.

A regulatory authority requests the Trial Master File (TMF) during an inspection. What does the TMF contain?

Answer: All essential documents that permit evaluation of the conduct of a trial and quality of data

The TMF is a comprehensive archive of essential regulatory, protocol, consent, and safety documents required to demonstrate study integrity and compliance.

Which type of bias occurs when a researcher selectively reports only statistically significant outcomes while omitting non-significant ones?

Answer: Publication bias / outcome reporting bias

Outcome reporting bias (a form of publication bias) occurs when statistically significant results are preferentially reported, distorting the evidence base.

What is a protocol synopsis used for in clinical research communication?

Answer: Providing a concise summary of the protocol for potential sites, collaborators, or ethics committees to assess feasibility

A protocol synopsis summarizes key study elements — objectives, design, population, and endpoints — to help stakeholders quickly evaluate whether participation is feasible.

When writing a research grant proposal, the 'Specific Aims' page primarily serves to:

Answer: State the research gap, long-term goal, objectives, and expected impact in one page

The Specific Aims page is the most critical section, framing the problem, proposed work, and significance so reviewers can quickly understand the proposal's value.

An electronic data capture (EDC) system generates an automatic audit trail. What information does this audit trail typically capture?

Answer: Who made each data entry or change, when it was made, and what the previous value was

EDC audit trails record the identity of the user, timestamp, and original value for every data entry or modification, supporting data traceability and GCP compliance.

Which element distinguishes a 'query' in clinical data management from a protocol deviation?

Answer: A query is a data clarification request about a specific entry; a deviation is a departure from the approved protocol

A data query asks the site to clarify or correct a data discrepancy, while a protocol deviation documents that a study procedure was not followed as approved.