Compliance modeling

Office of Inspector General s Compliance Model for the Pharmaceutical Industry. 

The Trial Simulator (Pharsight Corp., http //www.pharsight.com) is a comprehensive and powerful tool for the simulation of clinical trials. Population PK/PD models developed with tools mentioned in Section 17.10.3 can be implemented in a Trial Simulator. In addition, treatment protocols, inclusion criteria, and observations can be specified. Also covariate distribution models, compliance models, and drop-out models can be specified. All of these models can be implemented via a graphical user interface. For the analysis of simulation results a special version of S-Plus is implemented and results can also be exported in different formats, like SAS. 

MMCC had followed a basic assessment plan for a little more than a decade. As with a lot of assessment plans, ours identified some key data sources and intended outcomes but left the process of assessment heavily weighted toward an administrative model of compliance. The problem with compliance models is that there is little internal dialogue about what is really learned and the institutional context never gets any smarter as a... 

USE 2ND RANDOM SOURCE FOR COMPLIANCE MODEL - COMPLIANCE IS RANDOM... 

Compliance model Compliance as an outcome modeled as a response or utilized as a covariate expressed in the nonlinear mixed effect model Indicator variable Compliance as a quantal (i.e., 0 = compliant ... 

The important and empirically significant middle ground between the sanctioning and compliance model is characterized by differences in rule interpretation and varying propensities to use legal coercion (Bardach and Kagan, 1982 Braithwaite et al., 1987 Hutter, 1988). 

Table 3.6 Screen Compliance Model Parameters for Three Different Screens...

Compliance modelling has been used to very good effect in the optimisation of plumbosolvency control in the United Kingdom, particularly in the optimisation of orthophosphate dosing. Over 100 water supply systems have been modelled, involving 30% of the UK s water companies. This proof-of-concept project had the overall objective of demonstrating that these modelling techniques could also be applicable to the circumstances of Canada and the United States, via three case studies. 

In compliance modelling for a water supply system, the most important calibration data are (i) the lengths and diameters of the lead service lines (ii) the types (copper, brass, etc), lengths and diameters of premise plumbing (iii) the plumbosolvency of the water and (iv) the percentage of homes with a lead service line in the water supply system. The extent of this data varied in the three case studies necessitating the use of some assumptions, which were adjusted (to a limited extent) in order to match predicted compliance results to those observed. Obtaining adequate calibration data in the future on pipework characteristics should not be particularly onerous or costly, particularly if opportunities to undertake brief inspections of service connections... 

The calibration of the zonal compliance model was an iterative process that involved matching predicted compliance LCR data to that observed by the Utility, and it is important to put this into perspective ... 

Presently, too little data has been provided to be able to calibrate the zonal compliance model to the extent possible for Cities A and B. However, a speculative exercise has been undertaken, based on the pipe-work characteristics of Cities A and B and assuming plumbosolvency factors ranging from Af= 0.03 to 0.05 and = 45 to 75. These plumbosolvency factors reflect (i) the lead concentrations observed in the sequential sampling surveys, and (ii) reference to extensive UK data from laboratory testing for low orthophosphate doses to moderately high alkalinity waters. 

Only limited data was available to calibrate the compliance model, but speculative simulations have demonstrated how modelling can provide a deeper insight into plumbosolvency control. 

The three case examples from City A, in which simulated and observed sequential sample results have been compared, are shown in Figures 8.3 to 8.5, based on 6+ hours stagnation. In all cases, the plumbosolvency factors M = 0.047 and =70 were applied (as used in the LCR compliance modelling). 

The main objective of this collaborative research project was to demonstrate the applicability of computational compliance modelling in the North American context following its successful use in the optimisation of plumbosolvency control in the UK. This objective was achieved. 

Computational compliance modelling has been shown to have an important potential role in the optimisation of plumbosolvency control in both Canada and the United States. Modelling tools can also support investigations at individual homes, if the specific cahbration data are available. 

Computational compliance modelling has given a preliminary indication that there is scope to further reduce lead concentrations in City A by orthophosphate dosing, but operational feasibility would first need to be confirmed. Computational compliance modelling indicates that the current plumbosolvency control treatment measures in City B are close to optimum by pH elevation alone. 

I The Compliance, Safety, Accountability (CSA) enforcement program is a whole new methodology in determining a carrier s fitness. Under CSA, the Federal Motor Carrier Safety Administration (FMCSA) is introducing three new components to the Agency s enforcement and compliance model ... 

Analysis Analysis is the use of analytical data, modeling, or simulation to show theoretical compliance. Modeling and simulation such as computational... 

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