Certified Clinical Research Associate (CCRA) Practice Exam

Privacy is an important consideration in clinical research; however, it is not explicitly outlined as a required aspect of source data according to the ICH guidelines. The ICH (International Council for Harmonisation) emphasizes the importance of legibility, accuracy, and completeness of source data, as these elements ensure that the data can be reliably interpreted and validated.

Legibility ensures that the information can be read and understood by any person reviewing the data. Accuracy is critical because it reflects the correctness of the data collected, which directly affects the integrity of the study results. Completeness refers to whether all necessary information is fully recorded without any omissions, as missing data can hinder the evaluation of the study's outcomes. While privacy must be maintained to protect patient information, it does not belong to the core aspects required for source data per the ICH guidelines, which focus more on the quality and integrity of the data itself.