{"id":398,"date":"2018-05-29T11:39:42","date_gmt":"2018-05-29T11:39:42","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/glossary\/medschool-glossary-investigators-brochure-ib\/"},"modified":"2024-11-19T22:29:13","modified_gmt":"2024-11-19T22:29:13","slug":"investigators-brochure-ib","status":"publish","type":"glossary","link":"https:\/\/az.research.umich.edu\/medschool\/glossary\/investigators-brochure-ib\/","title":{"rendered":"Investigator\u2019s Brochure (IB)"},"template":"","class_list":["post-398","glossary","type-glossary","status-publish","hentry"],"acf":{"glossary_term_description":"<p>The IB is a comprehensive document summarizing the body of information about an investigational product (\"IP\" or \"study drug\") obtained during a&nbsp;<a href=\"http:\/\/en.wikipedia.org\/wiki\/Drug_trial\">drug trial<\/a>. The IB is critically important throughout the drug development process and is updated with new information as it becomes available.<\/p>\n\n<ul>\n\t<li>The purpose of the IB is to compile data relevant to studies of the investigational product in human subjects gathered during preclinical and other trials.<\/li>\n\t<li>An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial.<\/li>\n\t<li>An IB may introduce key aspects and safety measures of a protocol, such as:<\/li>\n\t<li>Dose (of the study drug),<\/li>\n\t<li>Frequency of dosing interval,<\/li>\n\t<li>Methods of administration, and<\/li>\n\t<li>Safety monitoring procedures.<\/li>\n\t<li>The sponsor is responsible for keeping the information in the IB up-to-date. The IB should be reviewed annually and must be updated when any new and important information becomes available, such as when a drug has received marketing approval and can be prescribed for use commercially.<\/li>\n<\/ul>","glossary_related_terms":"","legacy_glossary_node_id":631,"legacy_related_terms":""},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/glossary\/398","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/glossary"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=398"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}