Standards Development

Scope

ACRES-QC S001 specifies requirements for the quality management of clinical research trials. It covers the management of clinical research trials within any medical specialty which are carried out by hospitals, universities or specialist centres for specific diseases or types of care.

ACRES-QC S001 covers aspects of quality which can be defined and controlled by a clinical research site conducting clinical research trials. Such aspects of quality are maintained through the implementation of processes, procedures, and responsibilities pertaining to the management, governance, physical environment and the control and maintenance of systems which are connected to the framework around the running of clinical research trials. ACRES-QC S001 also covers communications and interactions between clinical trial participants and those staff members involved in the clinical research trials. In addition, ACRES-QC S001 includes requirements around ethics and risk.

 It includes neither the design of clinical research trials nor the design of the clinical trial protocol and risk management associated with the design of the clinical trial protocol. It also does not include the ongoing treatment of patients.

 ACRES-QC S001 is for use by those responsible for clinical research sites which are engaged in conducting clinical research trials.

NOTE ACRES-QC S001 covers clinical research trials which might be studies, or cover pharmacological products, or devices, for example. See also 3.1.7.

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