Audit monitoring

While it is not the sponsor s responsibility to carry out the work, it is its responsibility to ensure it is done correctly and in accordance with the sponsor s standards and commitments to the regulatory agencies. It is critical to verify that vendors are meeting compliance and contractual obligations by performing an initial qualification audit and periodic monitoring audits. 

Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. For more information on the FDA s GCP program, go to http //... 

Returning to the clinical activities listed in Table 3, some thoughts on the level of support that is realistic to obtain from CROs are as follows. A number of the labor-intensive activities, such as monitoring, auditing, database management, programming for listings and tables, and statistical interpretation are relatively easy to outsource, and many CROs will have the necessary experience and capacity. 

During the operations phase, new hazards are identified by periodic inspections, worksite monitoring, audits, and appraisals. Techniques used to identify hazards during the operations phase include checklists, PET analysis, and safety studies. Accident analysis is also an important method of detecting previously undetected or uncorrected hazards. Accident analysis tools include change analysis, PET analysis, MORT and mini-MORT analysis, and event and causal factors charts. 

Monitoring audit, and comparison Were adequate provisions made to evaluate the safety program and the safety program review effort Were meaningful comparisons with similar organizations or operations included ... 

Questions and answers. This is a subcategory of the structured alphanumeric data but because it has special relevance to health and safety it is dealt with separately. Packages for active monitoring, audit, attitude surveys and measuring safety culture accept these types of data. 

Monitoring, auditing and reviewing fire safety systems... 

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