Phase 3 Study Site Audit: Ensuring Data Integrity and Collaboration

Dear Site Staff,

We hope this letter finds you well. As you know, our Phase 3 study is ongoing, and we greatly appreciate your participation in this vital research. We've identified your site as an outlier in terms of the efficacy between the treatment group and the control group, and we are planning to conduct a second audit at your site.

We understand this might cause some inconvenience, but we want to assure you that this audit is crucial for maintaining the integrity of our study results. We value your cooperation thus far and request your continued support throughout this audit process.

We encourage open communication and welcome any concerns or questions you may have during the audit. We believe that open communication is essential to the success of our study and are committed to working with you to ensure our study is conducted with the highest standards of quality and ethics.

Thank you again for your participation in our study. We appreciate your dedication and look forward to working with you to achieve our common goal.

Sincerely,

[Your Name] Clinical Project Manager