CRP Communication & Documentation 2 — Questions and Answers
Question 1: Which section of a research report typically contains the statistical methods used to analyze collected data?
- Introduction
- Methodology (Correct answer)
- Results
- Discussion
Correct answer: Methodology
The Methodology section describes the statistical and analytical methods used to process and analyze the data collected.
Question 2: When documenting adverse events in a clinical study, which timeline is generally required for reporting a serious unexpected adverse event to the IRB?
- Within 24 hours
- Within 7 calendar days (Correct answer)
- Within 30 calendar days
- At the next scheduled progress report
Correct 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.
Question 3: A research team is preparing a manuscript for peer-reviewed publication. What is the purpose of including a 'Limitations' subsection in the Discussion?
- To request more funding for future studies
- To acknowledge factors that may affect the validity and generalizability of findings (Correct answer)
- To criticize competing studies
- To list excluded participants
Correct 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.
Question 4: Which documentation practice best ensures the integrity of a research participant's consent process?
- Obtaining verbal consent and recording it in field notes
- Having the participant sign the consent form and retaining a dated copy in the study file (Correct answer)
- Emailing the consent form to the participant after enrollment
- Filing consent forms only at study close-out
Correct 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.
Question 5: In ALCOA principles applied to research documentation, what does the 'A' stand for?
- Accurate
- Attributable (Correct answer)
- Authorized
- Archived
Correct answer: Attributable
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate — core data-integrity standards for research records.
Question 6: A researcher must correct an error in a paper source document. Which practice follows Good Documentation Practice (GDP)?
- Use white-out to cover the error and write the correction above it
- Draw a single line through the error, write the correction, date it, and initial it (Correct answer)
- Tear out the page and rewrite it
- Delete the entry and leave the space blank
Correct 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.
Question 7: Which element is essential when writing a research abstract intended for a scientific conference?
- Full references list
- Detailed raw data tables
- Structured summary covering objective, methods, results, and conclusion (Correct answer)
- Biographical sketch of all authors
Correct 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.
CRP Communication & Documentation 2
Which section of a research report typically contains the statistical methods used to analyze collected data?