'Irb iec' presentation slideshows

INVESTIGATOR RESPONSIBILITIES

INVESTIGATOR RESPONSIBILITIES. April 2016. Objectives. Review and Discuss: Responsibilities of the clinical research Investigator as per relevant regulations and guidelines.

740 views • 64 slides

776 views • 58 slides

MP-7 Investigator Meeting January 31, 2011

528 views • 50 slides

Overview of Good Clinical Practices (GCPs)

Overview of Good Clinical Practices (GCPs). Barbara Pennington, RN, MS PPD. Why Regulate Clinical Research?. Ensure the rights, safety, and well-being of participants Scientific Integrity of data. Good Clinical Practices (GCPs).

614 views • 40 slides

Clinical trials with reference to GCP Guidelines

Clinical trials with reference to GCP Guidelines. Certificate course in Research Ethics Review (CCRER) 25 th April 2008 Priyadarshani Galappatthy MD,MRCP Department of Pharmacology. Overview. Definition and phases of clinical trials Principles of GCP guidelines

701 views • 38 slides

Justification of Research in Humans

Justification of Research in Humans. Impossible to reach the important conclusions without studying humans Human physiologic studies, because animal responses often are not the same Epidemiological studies, because they depend on human susceptibilities and human interactions

506 views • 36 slides

Justification of Research in Humans

Justification of Research in Humans. Impossible to reach the important conclusions without studying humans Human physiologic studies, because animal responses often are not the same Epidemiological studies, because they depend on human susceptibilities and human interactions

516 views • 36 slides

Responsibilities of Sponsor, Investigator and Monitor

Responsibilities of Sponsor, Investigator and Monitor. Sponsor Investigator Clinical research associate Clinical research coordinator. Learning Objective Roles and Responsibilities of the. Key Players in a Clinical Trial. CRA. Patient. Investigator. Clinical Trial. Regulatory

344 views • 25 slides

Harmonization - ICH

Harmonization - ICH. Robert J. Temple, MD Deputy Center Director for Clinical Science FDA/Center for Drug Evaluation and Research. SACHRP March 9, 2010. ICH - History.

415 views • 11 slides

Initiation Visit

Initiation Visit. Initiation Visit. An Initiation visit should never take place before unconditional written approval of the IRB/IEC has been obtained Training / Explaining Initiation visit = GREEN LIGHT for the recruitment of patients in the trial. Initiation Visit.

142 views • 6 slides