The use of study forms at Clinical Trial Sites
OverviewVarious study forms (logs, templates etc.) are being used at Clinical Trial Sites in order to facilitate the conduct of Clinical Trials and to properly document actions taken. All these…
Execution of Clinical Trial Agreements
OverviewAccording to regulations it is required that all Parties conducting particular Clinical Trial are legally bound with contractual arrangements (agreements).There are various agreements between the Parties involved in Clinical Trials,…
Risk Assessment as part of Quality Risk Management
OverviewQuality Risk Management (QRM) is an integral part of the corporate Quality Management System. Effective QRM is fundamental to ensuring the protection of human Subjects participating in Clinical Trials and…
Clinical Site Audits
OverviewClinical Site Audits are performed by Sponsors as part of quality assurance implementation in the Clinical Study (Trial).The audit is independent of and separate from routine monitoring or other quality…
Project Management in Clinical Trials
OverviewProject 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 requirements and GxP guidelines (e.g., Good…
Management of Trial Master File
OverviewThe vital part of each Clinical Trial conduct is management of Essential Documents.According to established Good Clinical Practice (GCP) guidelines “Essential Documents are those documents which individually and collectively permit…
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 be available on Sponsor’s side…
Feasibility and Site Identification
OverviewFeasibility and Site identification are fundamental critical aspects of planning and executing successful Clinical Trials.Feasibility and Site identification involves identifying potential Sites that meet the study's eligibility criteria, based on…
Regulatory Affairs in Clinical Trials and related Communications
OverviewRegulatory Affairs are staff whose main responsibilities are to prepare and perform submissions of clinical trial materials to Regulatory Authorities (RAs), Institutional Review Boards (IRBs)/ Independent Ethics Committees (IECs) and…
Investigator Meeting and other Study Meetings
OverviewAccording to the Good Clinical Practice “The Investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial…”, therefore proper training is…