{"id":1295,"date":"2019-08-20T04:54:45","date_gmt":"2019-08-20T09:54:45","guid":{"rendered":"https:\/\/dhrresearch.org\/?p=1295"},"modified":"2022-01-28T14:41:22","modified_gmt":"2022-01-28T20:41:22","slug":"the-pis-guide-to-conducting-clinical-research-second-edition","status":"publish","type":"post","link":"https:\/\/dhrresearch.org\/the-pis-guide-to-conducting-clinical-research-second-edition\/","title":{"rendered":"The PI\u2019s Guide to Conducting Clinical Research, Second Edition"},"content":{"rendered":"\n<p>The principal investigator is charged with meeting the demands of conducting faster clinical trials\u2026 adhering to stricter requirements from sponsors and regulatory bodies\u2026 managing increased competition in the market\u2026 all while maintaining the highest quality and patient safety standards.<\/p>\n\n\n\n<p><strong>The PI\u2019s Guide to Conducting Clinical Research<\/strong>&nbsp;is the only industry resource designed to assist both novice and experienced PIs in meeting these higher, more challenging expectations to conduct better, safer and more efficient clinical trials.<\/p>\n\n\n\n<p>New in this edition:<\/p>\n\n\n\n<ul><li>The impact of Common Rule and ICH E6 revisions<\/li><li>Inspections and audits of investigators and their sites<\/li><li>New requirements for oversight of investigational drugs<\/li><li>Challenges involved in maintaining electronic systems and ensuring compliance<\/li><li>Delegation of authority and oversight of sub-investigators<\/li><li>The role of registry studies and retrospective data collection studies<\/li><li>Informed consent training of staff<\/li><li>Coordinating with testing centers<\/li><li>Innovative patient recruiting methods<\/li><li>Risk-based and remote monitoring methods<\/li><\/ul>\n\n\n\n<p>This newly, updated guide is packed with information regarding your responsibilities including practical and ethical study conduct, site and financial management, and responsibilities imposed by ICH E6(R2). It\u2019s your guide to understanding how to:<\/p>\n\n\n\n<ul><li>Secure new clinical studies, assess feasibility and create study budgets<\/li><li>Comply with changing federal regulatory guidelines<\/li><li>Implement and adhere to strict standard operating procedures<\/li><li>Recruit and retain study volunteers<\/li><li>Conduct informed consent and protect human subjects<\/li><li>Prepare for sponsor or IRB audits<\/li><li>Prepare for certification exams<\/li><\/ul>\n\n\n\n<p>Order your copy today!<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Who Will Benefit<\/h3>\n\n\n\n<ul><li>Physician investigators, principal investigators, sub-investigators and clinical research scientists interested in or already conducting clinical trials for pharmaceutical or biotech companies<\/li><li>Instructors conducting clinical research training and educational programs<\/li><li>Professors or researchers developing college curriculums<\/li><\/ul>\n\n\n\n<p><a href=\"http:\/\/store.centerwatch.com\/p-607-the-pis-guide-to-conducting-clinical-research-second-edition.aspx\" target=\"_blank\" rel=\"noopener noreferrer\">http:\/\/store.centerwatch.com\/p-607-the-pis-guide-to-conducting-clinical-research-second-edition.aspx<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The principal investigator is charged with meeting the demands of conducting faster clinical trials\u2026 adhering to stricter requirements from sponsors and regulatory bodies\u2026 managing increased competition in the market\u2026 all while maintaining the highest quality and patient safety standards. The PI\u2019s Guide to Conducting Clinical Research&nbsp;is the only industry resource designed to assist both novice [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[40],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/dhrresearch.org\/wp-json\/wp\/v2\/posts\/1295"}],"collection":[{"href":"https:\/\/dhrresearch.org\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dhrresearch.org\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dhrresearch.org\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dhrresearch.org\/wp-json\/wp\/v2\/comments?post=1295"}],"version-history":[{"count":0,"href":"https:\/\/dhrresearch.org\/wp-json\/wp\/v2\/posts\/1295\/revisions"}],"wp:attachment":[{"href":"https:\/\/dhrresearch.org\/wp-json\/wp\/v2\/media?parent=1295"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dhrresearch.org\/wp-json\/wp\/v2\/categories?post=1295"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dhrresearch.org\/wp-json\/wp\/v2\/tags?post=1295"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}