CCDM Data Collection Methods 2 — Questions and Answers
Question 1: Which data collection method is MOST appropriate when a clinical site lacks a reliable internet connection for real-time data entry?
- Electronic Data Capture (EDC)
- Paper Case Report Forms (CRFs) (Correct answer)
- Interactive Voice Response (IVR)
- Direct Data Entry (DDE)
Correct answer: Paper Case Report Forms (CRFs)
Paper CRFs are the appropriate fallback when electronic systems are unavailable due to connectivity issues.
Question 2: In a decentralized clinical trial (DCT), which data collection approach allows patients to report outcomes directly from their homes?
- Site-based CRF entry
- Central laboratory data upload
- Electronic Patient-Reported Outcomes (ePRO) (Correct answer)
- Investigator assessment forms
Correct answer: Electronic Patient-Reported Outcomes (ePRO)
ePRO tools enable patients to submit outcome data remotely from home devices, supporting decentralized trial designs.
Question 3: What is the primary purpose of a Data Collection Tool (DCT) validation plan in clinical trials?
- To train clinical site staff on data entry
- To ensure the tool meets predefined specifications and regulatory requirements (Correct answer)
- To schedule data transfers to the sponsor
- To define the randomization algorithm
Correct 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.
Question 4: Which type of data is collected through wearable biosensors in modern clinical trials?
- Adverse event verbatim terms
- Continuous physiological measurements such as heart rate (Correct answer)
- Protocol deviation narratives
- Investigational product lot numbers
Correct answer: Continuous physiological measurements such as heart rate
Wearable biosensors passively capture continuous physiological data like heart rate, activity levels, and sleep patterns.
Question 5: When source data is entered directly into an EDC system without prior paper records, this is referred to as:
- Remote Data Entry (RDE)
- Electronic Source (eSource) (Correct answer)
- Secondary data capture
- Transcription-based entry
Correct answer: Electronic Source (eSource)
eSource refers to data that originates electronically at the point of care, eliminating the need for paper source documents.
Question 6: Which regulatory guidance specifically addresses the use of computerized systems in clinical investigations, impacting EDC use?
- ICH E6(R2)
- FDA 21 CFR Part 11 (Correct answer)
- ICH E9
- FDA 21 CFR Part 312
Correct answer: FDA 21 CFR Part 11
FDA 21 CFR Part 11 sets requirements for electronic records and electronic signatures used in clinical investigations.
Question 7: A clinical trial uses an Interactive Web Response System (IWRS) for randomization. What additional data collection function can IWRS serve?
- Protocol amendment tracking
- Drug supply management and dispensing records (Correct answer)
- Adverse event coding
- Statistical analysis planning
Correct answer: Drug supply management and dispensing records
IWRS can manage and record investigational product dispensing and inventory, beyond its randomization function.
CCDM Data Collection Methods 2
Which data collection method is MOST appropriate when a clinical site lacks a reliable internet connection for real-time data entry?