Practice Test Geeks(CCDM) Certified Clinical Data Manager Practice Test
← All CCDM Flashcard Decks

Data Collection Methods Flashcards

7 cards from real CCDM 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 Methods flashcards as text

  1. Which data collection method is MOST appropriate when a clinical site lacks a reliable internet connection for real-time data entry?

    Answer: Paper Case Report Forms (CRFs)

    Paper CRFs are the appropriate fallback when electronic systems are unavailable due to connectivity issues.

  2. In a decentralized clinical trial (DCT), which data collection approach allows patients to report outcomes directly from their homes?

    Answer: Electronic Patient-Reported Outcomes (ePRO)

    ePRO tools enable patients to submit outcome data remotely from home devices, supporting decentralized trial designs.

  3. What is the primary purpose of a Data Collection Tool (DCT) validation plan in clinical trials?

    Answer: To ensure the tool meets predefined specifications and regulatory requirements

    A DCT validation plan verifies that the data collection tool consistently performs as intended and complies with regulatory standards.

  4. Which type of data is collected through wearable biosensors in modern clinical trials?

    Answer: Continuous physiological measurements such as heart rate

    Wearable biosensors passively capture continuous physiological data like heart rate, activity levels, and sleep patterns.

  5. When source data is entered directly into an EDC system without prior paper records, this is referred to as:

    Answer: Electronic Source (eSource)

    eSource refers to data that originates electronically at the point of care, eliminating the need for paper source documents.

  6. Which regulatory guidance specifically addresses the use of computerized systems in clinical investigations, impacting EDC use?

    Answer: FDA 21 CFR Part 11

    FDA 21 CFR Part 11 sets requirements for electronic records and electronic signatures used in clinical investigations.

  7. A clinical trial uses an Interactive Web Response System (IWRS) for randomization. What additional data collection function can IWRS serve?

    Answer: Drug supply management and dispensing records

    IWRS can manage and record investigational product dispensing and inventory, beyond its randomization function.