CRP Communication & Documentation 2

Question 1

Which section of a research report typically contains the statistical methods used to analyze collected data?

Accepted Answer

Methodology

Answer

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?

Accepted Answer

Within 7 calendar days

Answer

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?

Accepted Answer

To acknowledge factors that may affect the validity and generalizability of findings

Answer

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?

Accepted Answer

Having the participant sign the consent form and retaining a dated copy in the study file

Answer

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?

Accepted Answer

Attributable

Answer

ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate — core data-integrity standards for research records.

(CRP) Certified Research Professional Practice Test

(CRP) Certified Research Professional Practice Test

CRP Communication & Documentation 2