Practice Test Geeks(CRP) Certified Research Professional Practice Test
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CRP Research Project Management & Coordination Flashcards

6 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 6 CRP Research Project Management & Coordination flashcards as text

  1. What is the primary reason for maintaining source documents in clinical research?

    Answer: To provide original records that verify the accuracy of data entered in the CRF

    Source documents are the original records from which CRF data are derived, and they serve as the authoritative reference for data verification during audits.

  2. Under FDA regulations, how long must clinical investigators generally retain research records after a study is completed or discontinued?

    Answer: 2 years after marketing approval or after the investigation is discontinued

    FDA regulations (21 CFR 312.62) require investigators to retain records for at least 2 years after marketing approval or after the investigation is discontinued.

  3. What action should a coordinator take when a participant misses a scheduled study visit?

    Answer: Document the missed visit, attempt to contact the participant, and follow the protocol's missing data plan

    Missing visit procedures require documentation, re-contact attempts, and adherence to the protocol's plan for handling missing data to maintain data integrity.

  4. What is an Independent Data Safety Monitoring Board (DSMB) responsible for in a clinical trial?

    Answer: Periodically reviewing accumulating safety and efficacy data to recommend continuation, modification, or stopping of a trial

    A DSMB provides independent oversight of interim safety and efficacy data and can recommend stopping a trial early for safety, futility, or overwhelming benefit.

  5. What does 'database lock' signify in clinical trial project management?

    Answer: All data have been cleaned, queries resolved, and the database is frozen for final analysis

    Database lock means all data cleaning and query resolution are complete and the dataset is finalized before unblinding and statistical analysis.

  6. Which Good Clinical Practice principle requires that all persons involved in conducting a trial be qualified by education, training, and experience?

    Answer: The principle of qualified personnel

    ICH E6 GCP requires that all trial personnel be appropriately qualified and trained to ensure the reliability and integrity of trial conduct.