TrialSite is pleased to announce the 5th edition of the Clinical Research Coordinator Handbook authored by a great colleague and member of the TrialSite Network, Deborrah Norris In this fully revised and expanded fifth edition of the essential reference for clinical research coordinators, Ms. Norris offers expanded coverage on CRC duties and regulatory requirements, such as new sections on investigator responsibilities, data clarification, and adverse event reporting. Moreover, 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 as well as a glossary. The TrialSite team has collaborated with Mrs. Norris for over decade to take on some of the most challenging research sites.
The book covers these topics and more:
· Federal Regulations/GCP and ICH Guidelines
· Clinical Research Coordinator Responsibilities
· Investigator Responsibilities
· Obtaining Informed Consent/Assent
· Creating and Examples of Source Documents
· Electronic Data Capture (EDC)
· Preparing for Regulatory Inspections
· Reporting Study Results
Ms. Norris has been involved with hundreds of clinical trials and brings a level of rigor, expertise and experience and attention to detail few monitors can match. All of that accumulated knowledge is continuously updated into this must have book for the Clinical Research Coordinator.