Communication & Documentation Flashcards
7 cards from real CRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Communication & Documentation flashcards as text
Which section of a research report typically contains the statistical methods used to analyze collected data?
Answer: Methodology
The Methodology section describes the statistical and analytical methods used to process and analyze the data collected.
When documenting adverse events in a clinical study, which timeline is generally required for reporting a serious unexpected adverse event to the IRB?
Answer: Within 7 calendar days
Most IRBs and federal regulations require serious, unexpected adverse events to be reported within 7 calendar days of the investigator becoming aware.
A research team is preparing a manuscript for peer-reviewed publication. What is the purpose of including a 'Limitations' subsection in the Discussion?
Answer: To acknowledge factors that may affect the validity and generalizability of findings
The Limitations section transparently identifies constraints such as sample size, design issues, or biases that may affect how broadly results can be applied.
Which documentation practice best ensures the integrity of a research participant's consent process?
Answer: Having the participant sign the consent form and retaining a dated copy in the study file
A signed, dated copy retained in the study file provides auditable evidence that informed consent was obtained before study procedures began.
In ALCOA principles applied to research documentation, what does the 'A' stand for?
Answer: Attributable
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate — core data-integrity standards for research records.
A researcher must correct an error in a paper source document. Which practice follows Good Documentation Practice (GDP)?
Answer: Draw a single line through the error, write the correction, date it, and initial it
GDP requires that errors be corrected with a single strikethrough so the original entry remains legible, followed by the correction, date, and initials.
Which element is essential when writing a research abstract intended for a scientific conference?
Answer: Structured summary covering objective, methods, results, and conclusion
A structured abstract concisely conveys the study's purpose, methodology, key findings, and conclusions to allow readers to quickly assess relevance.