This course helps writers to meet the needs of various readers of Clinical Monitoring reports, including physicians, reviewers, auditors, regulatory agencies, and internal auditors.

This highly interactive, one-day seminar focuses on ensuring that comments on Clinical Monitoring Reports are clear, thorough, and objective.  Seminar content focuses on meeting needs of readers with different backgrounds and cultures.  These readers include physicians, reviewers, regulatory agencies, and internal auditors.

In addition, participants in this seminar learn to use a process approach to write clear, concise, and organized clinical documents that accomplish the purpose and meet readers’ needs.  These documents may include protocols, SOPs, Informed Consents, and research reports.

Seminar Topics

• Clarifying the readers’ needs and the writers’ challenges

• Evaluating monitor report comments for clarity, appropriate content, and correctness

• Using a writing process

• Organizing content

• Being clear and concise

• Formatting for the reader who skims

• Selecting information for a summary

• Reviewing for clarity, accuracy, and correctness

• Writing trackable corrective actions