DATA INTEGRITY AND GOOD CLINICAL PRACTICES: ENSURING RELIABLE STUDY RESULTS
*Mohamed Salih Aslam J. and Ragavan L.
ABSTRACT
In the dynamic landscape of clinical research, data integrity serves as a fundamental pillar, encapsulating the accuracy, consistency, and reliability of data throughout its lifecycle. Good Clinical Practices (GCP), a set of ethical and scientific standards, play a pivotal role in upholding the highest quality in clinical trials. This review explores the symbiotic relationship between data integrity and GCP, elucidating how their integration is imperative for the generation of trustworthy study outcomes. The article delves into the standardized processes outlined by GCP, emphasizing the importance of proper documentation, protocol adherence, and comprehensive record-keeping in maintaining data integrity from the outset. It further underscores the significance of continuous training and education for all personnel involved in clinical trials, equipping them with the knowledge and skills to uphold data integrity practices. Advocating for a continuous commitment to embracing emerging technologies, fostering a culture of ethical conduct, and staying informed about regulatory updates. This collective approach is crucial for overcoming challenges and maintaining the integrity of clinical trial data, thereby ensuring the reliability of study results.
Keywords: Data integrity, Good Clinical Practices (GCP), Clinical trials, Standardized processes, Protocol adherence.
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