Home └Good Clinical Laboratory Practice (GCLP)  Sponsored by the Gentaur Group └Chapter 1_ Introduction to Good Clinical Laboratory Practice (GCLP)

Good Clinical Laboratory Practice (GCLP)  Sponsored by the Gentaur Group

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Chapter 1_ Introduction to Good Clinical Laboratory Practice (GCLP)

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Chapter 1_ Introduction to Good Clinical Laboratory Practice (GCLP)
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1. What is the primary focus of Good Clinical Laboratory Practice (GCLP)?
Ethical conduct of clinical trials Pre-clinical data generation for new drugs Ensuring the quality and integrity of data from clinical trial laboratories Developing new laboratory techniques and equipment
2. What historical event is recognized as a major contributor to the emergence of GCLP?
The discovery of penicillin The creation of the World Health Organization (WHO) The identification of discrepancies between pre-clinical and clinical trial data The publication of the first clinical trial guidelines
3. Which of the following is NOT a benefit of adhering to GCLP?
Generating reliable data for regulatory decision-making Minimizing the risk of errors and contamination in sample handling Reducing the cost of conducting clinical trials Promoting public trust in the clinical research process
4. The core principles of GCLP are established by:
Individual research institutions International regulatory bodies The pharmaceutical industry Clinical trial sponsors
5. According to GCLP, what is a critical aspect of ensuring data integrity?
Rapid data analysis and reporting Meticulous documentation of laboratory procedures and observations Focusing solely on positive results from the study Limiting access to laboratory data
6. Which of the following is an example of a technology that can be used to enhance GCLP compliance?
Traditional paper-based laboratory notebooks Electronic data capture (EDC) systems Social media platforms for data sharing Manual data entry into spreadsheets
7. GCLP emphasizes the importance of ___ for laboratory equipment.
One-time calibration before initial use Regular calibration and maintenance Relying solely on manufacturer specifications Using the most expensive equipment available
8. What is the primary purpose of a Standard Operating Procedure (SOP) within the GCLP framework?
Providing a general overview of laboratory practices Outlining specific step-by-step instructions for laboratory processes Documenting the qualifications of laboratory personnel Presenting the expected outcomes of a clinical trial pen_spark
9. GCLP focuses primarily on laboratory practices within the context of:
Basic scientific research Clinical trials involving human participants Animal testing for drug development Quality control procedures for manufactured products
10. The future of GCLP is likely to involve:
A stricter focus on national regulations over international harmonization The integration of new technologies to improve data integrity and efficiency A decreased emphasis on patient safety considerations The elimination of the need for GCLP in clinical research