About the CPQA Assessment Program
CPQA provides a phased-based, leveled assessment program for identifying appropriate quality recommendations for the development, implementation, and operations for laboratories. The approach used by the program is individualized to meet the focus and needs of individual clinical trial networks and DAIDS-funded clinical pharmacology laboratories (CPLs).
CPQA promotes an interactive, positive experience for CPLs throughout the assessment process. CPQA believes that establishing good laboratory practices is key to the success of CPLs when performing clinical research, regardless of whether the research will be subject to an FDA audit or a state CLIA inspection. Underlying all each assessment level is the basic foundations for preparing CPLs for FDA inspections.
Assessments are determined by working with the CPQA Contract Officer’s Representative (COR) and are based on the priorities set by CPL proficiency testing outcomes, analytical validation report submissions, and network and sponsor priorities.
Assessment Levels
| Assessment level | Description |
|---|---|
| Consideration | Determine the capability and potential to develop an on-site CPL; may be conducted remotely |
| Development | Assist a developing CPL with technology transfer and assay implementation, establishing training tools and progressing its level of maturity |
| Implementation (Post-development) | Determine if the operations a developing CPL has reached an appropriate level of competence which affords the assignment of study sample analyses |
| Assessment | Assess the overall operations of a CPL |
| Pre-study | Assess the CPL prior to the CPL phase of a named study, specifically focusing on the operations that will support the laboratory during the PSL study phase |
| In-study | Assess the CPL for a named study, specifically focusing on the operations that support the laboratory during the CPL study phase |
| Post-Study | Assess the CPL for a named study, specifically focusing on the operations that supported the laboratory during the CPL study phase after the analyses have been completed and results reported |
| Requested | Assess the overall operations of a CPL at the request of the CPL itself |
| For Cause | Assess the operations of a CPL to determine if root cause of concern(s) can be identified and corrected |
