The CRA creates reports that have many audiences, one being regulatory authorities reviewing essential documentation for the review of clinical trials linked to marketing application approvals. This course presents 10 categories of scientific report writing in the context of the role of the CRA and the reports that they write. The applicable reports are monitoring visit reports, e-mails, telephone reports, memos to file, and more. The concepts of writing in a scientific voice versus first person, objective versus subjective and many more are presented. This course is invaluable for the CRA, as well as the individual who critiques the various reports.
- Examine the impact of poor report writing: audiences include regulatory authorities
- Apply definitions and concepts of scientific report writing
- Implement the 10 rules of quality report writing for CRAs
- Apply the 10 rules to the CRA activities
- Write action items, deviations, queries
- Integrate essential document mapping within a monitoring report
- Effectively appreciate the challenges of CRA report writing and report review for CRAs
- CRAs
- Project Managers
- CRA Managers
- Contract CRAs
Sandra SAM Sather, MS, BSN, CCRA, CCRC
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3 hours; 12:30 - 3:30 p.m. Eastern
May 10, 2010
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471