This module provides an overview of data safety monitoring, the functions of a data safety monitoring board (DSMB), and when using a DSMB is required.
This module describes the different classifications and levels of protocol deviations, explains reporting processes and consequences, and discusses best practices to avoiding protocol deviations.
This module discusses the significance of record-keeping and essential regulations, identifies different types of record and how to organize them, and reviews best practices and helpful tips.
This course covers topics on data definitions and management planning; data management of clinical sites; data processing and preparing a data analysis; and preparing data to share.
This module defines informed consent and assent, applies age guidelines for determining who can and cannot provide informed consent and assent, and explains key information disclosed to potential research subjects.
In this activity, the author explains the purpose and scope of an audit, defines the two audit conditions, and lists common compliance areas during an audit.
During the module, the speaker describes quality in clinical research, provides insights on Quality Management Systems (QMSs) and their purpose, and explains the documents that reside in a QMS. *ECHO ISPCTN Core Curriculum Module
This module goes over the background and significance of a quality management system, provides insight on how to put a QMS into practice, and identifies commonly faced obstacles and resources. *ECHO ISPCTN Core Curriculum Module
During this webinar, Dr. Snowden will discuss applying principles from the Quality Management Systems session to examples in clinical research and use peer learning to identify strategies for overcoming common obstacles in clinical research. *ECHO ISPCTN Core Curriculum Module
In this activity, the author defines a MOP (manual operating procedure) and its scope, explains the purpose of the Table of Events, demonstrates how to create source documents and worksheets, and explains how to use the protocol and MOP to plan and implement complete study visits.
This module goes over the guidelines to creating and implementing SOPs into your quality management systems and documents. *ECHO ISPCTN Core Curriculum Module
This module goes over the roles and responsibilities of protocol chairs, ways to enhance collaboration between protocol chairs, the study team, and site research teams, and lessons learned. *ECHO ISPCTN Core Curriculum Module
