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Data Collection & Analysis Flashcards

7 cards from real RA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Data Collection & Analysis flashcards as text

  1. A study records participants' blood type (A, B, AB, O). Which level of measurement is this?

    Answer: Nominal

    Blood types are unordered categories, which makes them nominal data.

  2. In the ALCOA data integrity principles, what does the letter 'C' stand for?

    Answer: Contemporaneous

    ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate, so 'C' means recorded at the time the activity is performed.

  3. A research assistant sees that a blood pressure value on the case report form (CRF) does not match the clinic chart. What is the correct next step?

    Answer: Raise a data query and resolve it against the source document

    The source document is the original record, so discrepancies are resolved through a documented query that checks the CRF against the source.

  4. Data are missing because a lab machine failed at random times that had nothing to do with participant characteristics. How would this missingness be classified?

    Answer: Missing completely at random (MCAR)

    When missingness is unrelated to both observed and unobserved data, it is missing completely at random.

  5. What is the main purpose of double data entry for paper CRFs?

    Answer: To detect transcription errors by comparing two independent entries

    Two people enter the same data independently, and the mismatches show where keying errors happened.

  6. Which U.S. regulation sets the requirements for electronic records, electronic signatures, and audit trails in FDA-regulated research?

    Answer: 21 CFR Part 11

    21 CFR Part 11 covers how trustworthy electronic records and signatures must be, including secure audit trails with time stamps.

  7. How should an RA correct an error on a paper source document under Good Clinical Practice?

    Answer: Draw a single line through it, write the correction, and initial and date it

    GCP requires the original entry to stay readable, with the correction initialed, dated, and explained if needed.