Clinical Research Coordinator Handbook
In this revised third edition of the essential reference for clinical research coordinators (CRCs), 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, a glossary, and more.
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Duties of the Clinical Research Coordinator
The Administrative Checklist 100
The Creation of Study Source Documents
15 other sections not shown
Administration adverse experiences advertisement and/or applicable appropriate AUTOENCODING Certificate of Accreditation CLIA Certificate CLIA Laboratory Certificate clinical investigation clinical Protocol Clinical Research Coordinator clinical study clinical trial Code of Federal completed conduct copy CRFs CRO/SMO Declaration of Helsinki dispensed Drug Accountability Record e-mail ensure FDA inspector FDA investigator Federal Regulations follow-up Form FDA Form FDA483 HCFA HIPAA human subjects Informed Consent Form initial inspection Institutional Review Board investigational product Investigator Brochure investigator's brochure IRB approval letter Microscopy Procedures monitoring noted notify Otitis Interna participation patient performed person physician potential subject prestudy Principal Investigator Protocol queries regulatory report form request research study responsible Review Board IRB screening serious adverse events Signature Signature Record signed source documents specific specimens study drug Study File study subject study-related procedures study-specific Subject Enrollment Telephone test articles verify Visit Log waived tests