Standard Operating Procedures for the Conduct of Clinical Research was developed to help clinical research sites meet the challenge of maintaining rigorous standards in a world of diminishing resources. During the last decade, financial, regulatory, and legal pressures have changed clinical research into a global enterprise with strict requirements for standardization, consistency, and compliance. In such an environment, only the best will succeed.
This newly revised template has been expanded to include more procedures to assess study feasibility, recruit subjects, and ensure regulatory compliance. Provided in a three-ring binder with a CD-ROM containing an MS Word program for Windows users only, this template is based on the Code of Federal Regulations and GCP Consolidated Guidelines.
Template features and topics include:
*Sample job descriptions *Evaluation forms *Chapters on general administration, study start up, quality assurance, privacy practices, and project and data management
Standard Operating Procedures for the Conduct of Good Clinical Research is designed to make its format compatible and content consistent with the other SOP templates in the series, which include:
* Policies and Standard Operating Procedures for the Institutional Review Board
* Standard Operating Procedures for Good Clinical Practice by Sponsors of Clinical Trials
* Standard Operating Procedures for Good Clinical Practice by Sponsors of Medical Device Clinical Trials
"synopsis" may belong to another edition of this title.
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