Validating clinical trial data reporting

Concepts and techniques are gently presented with hands-on examples and accompanying SAS code.The reader will appreciate the comprehensive review of important terminology such as CRF, e CTD, CDISC, ADa M, SDTM, SOP, SAP, and TLF.

Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email [email protected] Pharma This book provides a straightforward, concrete plan for meeting the complex validation requirements that clinical trial data reporting must adhere to.By including actual sample validation checklists in the book's appendix, the authors have allowed readers to implement the suggestions in the book with just a little effort.""Having taught a pharmaceutical-focused SAS programming class since 1998 using two other SAS Press publications, I am thrilled to say that this book will be such a benefit to my class as well as to others in the industry.Topics addressed include: Validation and pharmaceutical industry overviews Documentation and maintenance requirements discussions General techniques to facilitate validation Data importing and exporting Common data types Reporting and statistics This book is designed for SAS programmers who are new to the pharmaceutical industry as well as for those seeking a good foundation for validation in the SAS programming arena.Readers should have a working knowledge of Base SAS and a basic understanding of programming tasks in the pharmaceutical industry.

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