Clinical Research Coordinator Handbook
In this fully revised and expanded fourth edition of the essential reference for clinical research coordinators, Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The book s five appendices include a directory of CRC resources, updated forms and checklists, state regulatory requirements and contact information, conversion charts and tables, and a glossary.
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The Clinical Research Organization
Duties of the Clinical Research Coordinator
The Creation of Study Source Documents
31 other sections not shown
Adverse Event Adverse Experience andl applicable appropriate audit AUTOENCODING beneﬁts Certiﬁcate of Accreditation clariﬁcation Clinical Research Associate Clinical Research Coordinator clinical study clinical trial completed conduct conﬁdentiality conﬁrm Contract Research Organization copy CRO/SMO Date Declaration of Helsinki deﬁned dispensed Drug Accountability Record electronic data capture enrolled ensure Federal Regulations ﬁle ﬁnancial ﬁndings ﬁrst ﬂuid guidelines handbook HCFA Health HIPAA hisl identiﬁcation informed consent document informed consent form initial inspection Institutional Review Board investigational product investigator's brochure IRB approval monitoring visit noted notiﬁcation obtained ofﬁce participation patient performed person pharmaceutical companies physician potential subject prestudy Principal Investigator Protocol regulatory research study responsible scientiﬁc Signature signed signiﬁcant source documents speciﬁc specimens sponsoring pharmaceutical staff Study Coordinator study drug Study File study medication study subject study-related procedures study-speciﬁc Telephone test article treatment Website