InfoCRG Articles
Risk Assessment as part of Quality Risk Management
Overview Quality Risk Management (QRM) is an integral part of the corporate Quality Management System. Effective QRM is fundamental to ensuring the protection of human
Clinical Site Audits
Overview Clinical Site Audits are performed by Sponsors as part of quality assurance implementation in the Clinical Study (Trial). The audit is independent of and
Project Management in Clinical Trials
Overview Project Management activities are essentially required to start-up, execute, and complete a particular Clinical Trial (Study) project in compliance with study protocol, other Sponsor’s
Management of Trial Master File
Overview The vital part of each Clinical Trial conduct is management of Essential Documents. According to established Good Clinical Practice (GCP) guidelines “Essential Documents are
Third Party Vendor Management
A Clinical Trial can have multiple Third Party Vendors requiring effective oversight which can be challenging for Sponsors. The proper documentation proving continuous oversight must
Introduction to the Monitoring in Clinical Trials, Pre-Study Site Selection Visit
Overview As per Good Clinical Practice (GCP) guideline “the purposes of trial monitoring are to verify that: a) The rights and well-being of human subjects
Feasibility and Site Identification
Overview Feasibility and Site identification are fundamental critical aspects of planning and executing successful Clinical Trials. Feasibility and Site identification involves identifying potential Sites that
Regulatory Affairs in Clinical Trials and related Communications
Overview Regulatory Affairs are staff whose main responsibilities are to prepare and perform submissions of clinical trial materials to Regulatory Authorities (RAs), Institutional Review Boards
Investigator Meeting and other Study Meetings
Overview According to the Good Clinical Practice “The Investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of
Translation Services in Clinical Trials
Overview The majority of Clinical Trials are international and run in multiple countries, so in order to make their conduct successful many trial-related documentation needs