Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

What is a key responsibility of a sponsor regarding electronic trial data handling?

1. Ensure data is stored in multiple locations

2. Maintain an audit trail, data trail, and edit trail

3. Conduct regular data cleaning sessions

4. Train all site staff on data entry

The correct answer is: Maintain an audit trail, data trail, and edit trail

Maintaining an audit trail, data trail, and edit trail is a critical responsibility of a sponsor because it ensures the integrity and reliability of the data collected during clinical trials. These trails serve as a record that documents the history of data handling, including who has accessed and modified the data, what changes were made, and when those changes occurred. This level of documentation is essential for regulatory compliance and facilitates transparency, allowing for the verification of data integrity during audits or inspections by regulatory authorities. It helps ensure that all data alterations are traceable and justifiable, contributing to the overall quality and credibility of the clinical trial results. In the context of the other options, while ensuring data is stored in multiple locations could be beneficial for data security, it does not specifically address the need for auditable records of data manipulation. Conducting regular data cleaning sessions can help improve data quality but isn't primarily the sponsor's responsibility. Training site staff on data entry is crucial for quality, yet it falls more under site responsibilities rather than the sponsor's key obligations in electronic trial data management.