{"product_id":"good-clinical-practice-isbn-9780471969365","title":"Good Clinical Practice","description":"\u003cp\u003eThere is a growing trend for investigators to adopt a more formal approach to the procedures applied to various stages of clinical trials. Most environments employ some form of standard operating procedures which are designed to be used as 'working tools' within that particular field, e.g. standard operating procedures in hospitals for doctors and nurses. With rigorous standards of good clinical practice being applied to all areas, optimizing the design and use of standard operating procedures is more in demand every day. Topics covered include:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eA brief description of the history and development of clinical research and good clinical practice\u003c\/li\u003e \u003cli\u003eAn explanation of what standard operating procedures are and how they work\u003c\/li\u003e \u003cli\u003eA selection of actual standard operating procedures and checklists\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eThis well-constructed and timely work, set out in a logical, sequential order provides the necessary material needed to develop a useful set of investigator standard operating procedures.\u003c\/p\u003e Clinical Research.\u003cbr\u003e \u003cbr\u003e Phases of a Clinical Trail.\u003cbr\u003e \u003cbr\u003e Clinical Trial Design.\u003cbr\u003e \u003cbr\u003e History and Development of GCP.\u003cbr\u003e \u003cbr\u003e Good Clinical Practice -\u003cbr\u003e What is It?\u003cbr\u003e \u003cbr\u003e Responsibilities of the Investigator.\u003cbr\u003e \u003cbr\u003e Standard Operating Procedures.\u003cbr\u003e \u003cbr\u003e Organisation of Clinical Trials.\u003cbr\u003e \u003cbr\u003e Abbreviations.\u003cbr\u003e \u003cbr\u003e SOP 0: Preparation, Approval and Review of SOPs.\u003cbr\u003e \u003cbr\u003e SOP 1: Study Organisation and Planning.\u003cbr\u003e \u003cbr\u003e SOP 2: Study Team: Definition of Responsibilities.\u003cbr\u003e \u003cbr\u003e SOP 3: Study Files and Filing.\u003cbr\u003e \u003cbr\u003e SOP 4: Local Management Requirements.\u003cbr\u003e \u003cbr\u003e SOP 5: Review and Validation of the Protocol.\u003cbr\u003e \u003cbr\u003e SOP 6: Review of Protocol Amendments.\u003cbr\u003e \u003cbr\u003e SOP 7: Case Report Form (CRF) Review.\u003cbr\u003e \u003cbr\u003e SOP 8: Investigator's Brochure.\u003cbr\u003e \u003cbr\u003e SOP 9: Estimation of Patient Numbers.\u003cbr\u003e \u003cbr\u003e SOP 10: Ethics Committee.\u003cbr\u003e \u003cbr\u003e SOP 11: Indemnity, Compensation and Insurance.\u003cbr\u003e \u003cbr\u003e SOP 12: Laboratory.\u003cbr\u003e \u003cbr\u003e SOP 13: Pre-Study Monitoring Visits.\u003cbr\u003e \u003cbr\u003e SOP 14: Patient Recruitment and Intention to Enrol.\u003cbr\u003e \u003cbr\u003e SOP 15: Obtaining Personal Written Informed Consent.\u003cbr\u003e \u003cbr\u003e SOP 16: Obtaining Informed Consent for Patients Unable to Give Personal Consent.\u003cbr\u003e \u003cbr\u003e SOP 17: Randomisation and Stratification.\u003cbr\u003e \u003cbr\u003e SOP 18: Blinding: Codes and Code Breaking.\u003cbr\u003e \u003cbr\u003e SOP 19: Case Report Form (CRF) Completion.\u003cbr\u003e \u003cbr\u003e SOP 20: Study Drugs.\u003cbr\u003e \u003cbr\u003e SOP 21: Monitoring Visits.\u003cbr\u003e \u003cbr\u003e SOP 22: Adverse Event and Serious Adverse Event Reporting.\u003cbr\u003e \u003cbr\u003e SOP 23: Nursing Procedures.\u003cbr\u003e \u003cbr\u003e SOP 24: Clinical Procedures.\u003cbr\u003e \u003cbr\u003e SOP 25: Trial Report.\u003cbr\u003e \u003cbr\u003e SOP 26: Archiving.\u003cbr\u003e \u003cbr\u003e SOP 27: Audits and Inspections.\u003cbr\u003e \u003cbr\u003e FDA Regulations Concerning Clinical Trials.\u003cbr\u003e \u003cbr\u003e Index. \u003cp\u003e\u003cb\u003eJosef Kolman\u003c\/b\u003e is the editor of \u003ci\u003eGood Clinical Practice: Standard Operating Procedures for Clinical Researchers\u003c\/i\u003e, published by Wiley.\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePaul Meng\u003c\/b\u003e is the editor of \u003ci\u003eGood Clinical Practice: Standard Operating Procedures for Clinical Researchers\u003c\/i\u003e, published by Wiley.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eGraeme Scott\u003c\/b\u003e is the editor of \u003ci\u003eGood Clinical Practice: Standard Operating Procedures for Clinical Researchers\u003c\/i\u003e, published by Wiley.\u003c\/p\u003e Good Clinical Practice Standard Operating Procedures for Clinical Researchers Edited by Josef Kolman MPRC - Medical Pharmaceutical Research Center Ltd. Vienna, Austria Paul Meng PMC - Dr Paul Meng Consultant, Vienna, Austria and Graeme Scott Professional Services in Clinical Research, Edinburgh, Scotland There is a growing trend for investigators to adopt a more formal approach to the procedures applied to various stages of clinical trials. Most environments employ some form of standard operating procedures which are designed to be used as 'working tools' within that particular field, e.g. standard operating procedures in hospitals for doctors and nurses. With rigorous standards of good clinical practice being applied to all areas, optimizing the design and use of standard operating procedures is more in demand every day. Topics covered include:\u003cbr\u003e * A brief description of the history and development of clinical research and good clinical practice\u003cbr\u003e * An explanation of what standard operating procedures are and how they work\u003cbr\u003e * A selection of actual standard operating procedures and checklists\u003cbr\u003e This well-constructed and timely work, set out in a logical, sequential order provides the necessary material needed to develop a useful set of investigator standard operating procedures.","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989303673061,"sku":"NP9780471969365","price":197.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780471969365.jpg?v=1761783589","url":"https:\/\/k12savings.com\/products\/good-clinical-practice-isbn-9780471969365","provider":"K12savings","version":"1.0","type":"link"}