The Clinical Study Report (CSR) is a critical document in the drug development and regulatory submission process. This web seminar presents the basic tools required to generate CSRs for the pharmaceutical industry. Participants will learn the elements of the CSR and the appendices, methods for turning the protocol and statistical outputs into one cohesive document, the basics of writing and preparing a document for submission, and the guidances to follow for reference.
- Turn the protocol and data into clear concise submission documents
- Describe the elements required for the CSR and the appendices
- Differentiate the various types of statistical outputs and handling of the results
- Identify the phase of drug development differences and similarities
- Utilize style guides and templates
- Medical Directors
- Medical Writers
- Clinical Research Associates
- Clinical Scientists
- Regulatory Affairs Professionals
- Research and Development Personnel
- CRO Personnel
Click here for complete trainer biographies
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-13-050-L01-P. Released: 10/13.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.