Abstract
The statistics, data collection and management, and record keeping section of the study protocol describes how data will be collected, recorded, managed and stored. Applications of appropriate statistical strategies to data analysis and proper data collection and management procedures have important ethical implications. These include ensuring that participants do not assume risk without a reasonable expectation of benefit. Well-designed and implemented data management and record-keeping procedures protect participants from breaches of privacy and confidentiality. The RCR has, also, added new requirements.
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