SOCRA CCRP Practice Exam

What should be included in the Data Quality Assurance section of a study protocol?

1. Ethical assurance, Publication rights, Financing

2. Data recording, Study monitoring, Auditing

3. Investigator responsibilities, Informed consent, Protocol adherence

4. Subject recruitment, Safety reporting, Study monitoring

The correct answer is: Data recording, Study monitoring, Auditing

Data recording, study monitoring, and auditing are all important components of data quality assurance in a study protocol. These practices help ensure that the data collected is accurate, reliable, and consistent, and can be used to support the conclusions and findings of the study. Option A is incorrect because ethical assurance and publication rights are typically addressed in other sections of the study protocol, such as the ethical considerations and publication agreement sections. They are not directly related to data quality assurance. Option C is incorrect because while investigator responsibilities, informed consent, and protocol adherence are important considerations in a study protocol, they are not specifically related to data quality assurance. Option D is incorrect because while study monitoring and safety reporting are important aspects of a study, they are not synonymous with data quality assurance. Auditing, which involves regularly reviewing and checking the data collected, is a more direct and comprehensive method of ensuring data quality.