Little Advisor ICH GCP for In Vitro Diagnostic Trials (In Vitro Diagnostic Trials)

Prepared by clinical trials experts at Theorem Clinical Research, the Little Advisor: ICH GCP for In Vitro Diagnostic Trials condenses all the key concepts in the ICH Good Clinical Practice manual as they pertain to utilizing medical devices to assess analytes in vitro. Presented in a practical size with full citations back to the original document in case additional detail is required, clinical investigators get easy-to-find, practical information and good advice. All the topics in the original document are covered, including: ? Qualifications ? IRB/IEC ? Protocol Compliance ? Informed Consent Process ? Medical Care ? Safety Reporting ? IVD Accountability ? Documentation