Carpathian Research Groupsp. z o.o.Active

The use of study forms at Clinical Trial Sites

Various 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 documents are a part of Investigator Site File (a binder of trial related documentation) and Pharmacy File (a binder of documentation related to Investigational Medicinal Product; mainly used in Clinical Trials where there are blinded and unblinded Site teams with respect to study treatment received by subjects).

Execution of Clinical Trial Agreements

According to regulations it is required that all Parties conducting particular Clinical Trial are legally bound with contractual arrangements (agreements).

Adaptation of Study Materials to country-specific requirements

Nowadays the majority of Clinical Trials are multi-national involving various countries, so the main (“master”, typically English) versions of Study Materials should be adapted as per country-specific requirements in order for Sponsor to obtain trial authorisation from Regulatory Authorities and Ethics Committees.

Risk Assessment as part of Quality Risk Management

Quality 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 fundamental to reliability of Clinical Trial results.

Clinical Site Audits

Clinical Site Audits are performed by Sponsors as part of quality assurance implementation in the Clinical Study (Trial).

Project Management in Clinical Trials

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 requirements and GxP guidelines (e.g., Good Clinical Practice, Good Manufacturing Practice, Good Laboratory Practice etc.).