Showing results for "ich"

On Tech Ethics Podcast - Managing Healthcare Cybersecurity Risks and Incidents
Season 1 - Episode 35 - Managing Healthcare Cybersecurity Risks and Incidents Discusses various ethical and practical challenges organizations face i...
On Tech Ethics Podcast - Integrating AI into Healthcare Delivery
Season 1 - Episode 33 - Integrating AI into Healthcare Delivery Discusses the responsible integration of AI into healthcare delivery. ï»...
Clinical Study Operations (Good Clinical Practice)
This module provides an overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R...
Understanding the Specific Roles and Responsibilities Involved in the Clinical Monitoring Process
Overview: Clinical Trial Roles and Responsibilities A clinical monitoring plan is a carefully crafted template for each unique clinical study t...
Investigator Obligations
Discusses the commitments and obligations that investigators assume when participating in clinical investigations; the investigator's relationship wit...
Monitoring, Audits, Inspections, and Data and Safety Monitoring of Behavioral Interventions and Social Science Research
Identifies the oversight activities and responsibilities for monitoring visits, audits, inspections, and data and safety monitoring in accordance with...
Informed Consent in Clinical Trials of Drugs and Biologics
Discusses informed consent requirements as reflected in both FDA regulations and ICH guidelines, including obtaining and documenting consent. Includes...
Monitoring Clinical Trials of Drugs by Industry Sponsors
Describes the obligation of industry sponsors to monitor the progress of clinical trials under an investigational new drug (IND) application as well a...
Detecting and Evaluating Adverse Events
Defines adverse events (AEs) and related clinical trial terminology in accordance with ICH guidelines. Describes the process for identifying AEs in cl...
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