Quality Management

qualityManagement.jpgAccurate and reliable laboratory testing is necessary in order to provide quality data for successful clinical trials. The validity of diagnostic and monitoring tests is dependent upon the measures taken before, during and after each test. Various cross-network quality assurance working groups have developed guidelines for external quality assurance (EQA) monitoring, communication and data flow, and guidelines for the development of back-up plans. In addition, each non-US laboratory is assigned a Primary Network Laboratory (PNL) in order to facilitate cross-network communication regarding quality management issues and to respond to proficiency testing failures.

​GCLP Standards

Good Clinical Laboratory Practice (GCLP) Standards are developed and maintained by DAIDS. The GCLP Standards and Frequently Asked Questions are posted on the Clinical Research Support (CRS) Services website.

View the GCLP Standards and Frequently Asked Questions

Quality Assurance Partners​

DAIDS contracts with various quality assurance (QA) partners to provide proficiency testing and support to labs performing sample processing and testing to the networks.

Guidelines for Communication and Data Flow

Quality and efficiency of
protocol-related testing is maintained and improved under a Total Quality Management (TQM) Program.

More information

Guidelines for the Development of Plans for Back-Up Labs

Whenever possible, laboratories should have back-up plans in case an instrument or the whole laboratory is unavailable to perform testing.

More information

PNL Assignments

The Primary Network Laboratory (PNL) is responsible for sharing relevant information among a non-US site-affiliated laboratory and the network coordinators of all other affiliated networks.

More information

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