The Final Report

The final report, a list of nuclide activities, optionally with individual peak areas, is the object of all of the preceding 

For each nuclide, there may be several gamma-ray peaks measured, each with a different uncertainty depending upon its size and whether or not it has had to be deconvoluted or stripped. These must be combined in some way to produce a single result for each nuclide. It is worth consulting the software manual to establish how the final nuclide activity is calculated and just what is included in the quoted uncertainties. 

In situations where one or more peaks of a nuclide have an unresolved interference, there is a problem. If included in a normal weighted mean, they will affect the overall result for that nuclide adversely. It is common practice to quote a final uncertainty based only on the internal (or pooled) variance of the values (see Chapter 5, Section 5.3.2). It would be useful if programs also calculated the weighted (or external) variance and indicated when it exceeded the internal variance to alert the analyst to the fact that some other source of uncertainty was present. 

More complicated is the situation where several nuclides have mutually interfering peaks. Genie 2000 and Sampo 90 use what the manual refers to as a Common Algorithm Nuclide Identification . That identifies unresolved mutual interferences by a process of least squares minimization of a set of simultaneous equations, one for each nuclide, involving all of the peaks measured. The process is a more general treatment of the peak stripping explained in Section 9.11. 

There are programs which use the concept of a key peak . This might be the first entry for each nuclide in the nuclide library or be indicated by a flag within the library. A judgement may be made by the program on 

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Consider the environmental benefits and the savings in process and waste-treatment operating costs, along with the payback period for an investment, to decide which options are viable candidates. Once this is done, the audit team can develop draft recommendations to include in the final report and presentation to top management. 

WASH-1400 (FINAL), Appendix XI presents comments and responses on the draft repiirt. Some of these resulted in changes that were incorporated in the final report. Only a few critiques of the final report have been published. Two of these are NUREG/CR-0400 (Lewis Report) and Kendall, 1977. Of these, the Lewis Report s comments are the most objective (Leverenz and Erdmann, 1979, provide a review of the Lewis review). Some comments are summarized ... 

It is more common for a complete PSA to take 16 to 24 months with several rnuiilhs tor preparation, review, and revision of the final report. The final report for a level 3 nuclear plant PSA, includes an analysis of external events, in several large volumes. Completeness and consistency in such a large document requires several months of team leadership and selected analysts. Given these resources, it may be possible to complete the technical analyses for a Level 1 PSA in a year or less, but the final report will take several more months to prepare. 

Authorization to provide the final report to the lATF shall be specified in the certification contract. The auditor needs to advise the supplier at the Closing Meeting that a copy of the full report will be supplied to the lATF This also implies that the lATF is the auditor s customer. 

It should also be noted that the Final Report is not the initial report but the report containing the supplements that indicate all actions to be satisfactorily completed. 

Refer to the bibliography at the end of this chapter for a listing of the final reports of this program [67],... 

The final report will need to include a detailed description of the implementation procedure to demonstrate that the synthesized layout is feasible. 

Reporting of study results 9.1. General 9.2. Content of the final report 10. Storage and retention of records and materials Subpart J - Records and Reports Sec. 58.185 Reporting of nonclinical laboratory study results. Sec. 58.190 Storage and retrieval of records and data. Sec. 58.195 Retention of records. 

Additional studies of the Woburn population have been completed (MDPH 1994). The final report indicated that there was an increased prevalence in choanal atresia, a rare respiratory effect, and hypospadias/congenital chordee. A small increase in eye defects was observed, but there was no association between TCE exposure and heart defects. There was no statistically significant associations between exposure concentrations and birth defects, although analyses was limited by the small number of cases observed. Based on four cases in the Woburn population, a rate of 0.88 was observed in the exposed population, compared to rates of 0.11 and 0.13 in the Atlanta and California comparison populations, respectively. In a prospective study completed after well closure, the rate of choanal atresia was 0.88 (based on 1 case) in Woburn, 0.11 in the surrounding communities, and 0.2 and 0.13 in Atlanta and California, respectively. The study authors cautioned that their study did not rule out moderate increases in rates of the less common adverse reproductive outcomes. For these outcomes only large increases would have been detected. 

If the exploratory study Is conducted well. It will provide some data for achieving the overall objectives of the total monitoring study. It will provide a check of the feasibility and efficacy of all aspects of the monitoring design Including the QA/QC plan. It will serve as a training vehicle for participants. It will pinpoint where additional measurements need to be made. Finally, It will provide a body of Information and data which may be Incorporated Into the final report for the total monitoring study. 

Fourteen formulations of chemical alternatives were submitted to EPA under confidentiality and they were assessed based on numerous human health and ecotoxicity endpoints in addition to bioaccumulation potential and environmental persistence. They were also screened for potential exposure to workers, users and the aquatic environment. Where data gaps existed, EPA experts used models and chemical analogs to estimate the hazard for a particular endpoint. The literature and test data reviews were published in the final report, Environmentally Preferable Options for Furniture Fire Safety Low Density Furniture Foam . In addition, each hazard endpoint was ranked with a concern level (High, Moderate or Low) based on the criteria used by the EPA s New Chemicals Program to rate the concern level of new chemicals submitted under the Toxic Substance Control Act (TSCA). As seen in Figure 8.2, where the hazard endpoint rankings are bold, the value is based on experimental data. Where the hazard endpoints are presented in italic font, the value is estimated based on models or chemical analogs. In this way, detailed hazard information was summarized and presented in a clear and concise format. 

The slope of the land upon which the field trials will be established and the direction of the prevailing wind must be taken into consideration when locating the treated and untreated plots in a field trial. The protocol may specify a certain separation distance for the plots however, the PI must ensure that the plots are located with adequate separation to prevent contamination of the untreated plot during the course of the trial. The untreated plot must be located up-slope and up-wind from the treated plot to reduce contamination from wind or rain. When the land is level or the wind is not from a reasonably constant direction, then distance may be the only feasible way to ensure that plot integrity is maintained. Careful attention to plot placement in the field and documentation of this location in the field notebook will help minimize questions or concerns about the trial site during preparation of the final report. 

Reformatting of the final report to comply with the submission requirements of a national registration or regulatory authority does not constitute a correction, addition, or amendment to the final report. 

The final report should include, but not be limited to, the following information ... 

A quality assurance program statement listing the types of inspections made and their dates, including the phases inspected, and the dates when any inspection results were reported to management, to the Study Director, and to any Principal Investigators, if applicable. This statement would also serve to confirm that the final report reflects the raw data. 

The location where the study plan, samples of test and reference items, specimens, raw data, and the final report are to be stored. 

The processing report contains a summary of the processing data. An outline of each report element is presented in the following sections with clarifications added as needed. The processing report may be included as an appendix in the final report of the processing study to satisfy the FIFRA GLP Standards 40 CFR 160.185(a)(12). 

The data in each table and figure of reports submitted to sponsors should be verified by QA personnel. Team leaders, laboratory managers, field managers and the Study Director should meet routinely to discuss the meaning of the data as the study develops. This allows early discussions regarding data interpretation and allows several viewpoints to be explored, which ultimately strengthen the final report for the study. 

Purity analysis and characterization of the test substance should be performed for each lot. A retention sample from each batch of the test substance should be archived. All unused test substance and partially empty containers should be retained until the final report is signed, unless a prior waiver has been obtained from the EPA. 

Testing must be conducted in a typical end-user environment, or in a simulated end-user environment, identical with the environment where the software/computer system will be used. Documentation of testing can be recorded as raw data, such as in a logbook, and should include the parameters tested, and the results of testing. The data should be tabulated as a final report document that includes all details included in the test plan, their execution, the results, and conclusions. The final report document must be signed by appropriate personnel, reviewed as needed, and archived. Upon successful completion of testing, the software/computer system can be released for testing and use in an actual end-user environment. 

Curiously, there is no correspondence between the report by the Subcommittee on Pharmaceutical Care (which addresses issues such as generics and reference pricing) and the final report by the Committee. The Subcommittee disagreed on fundamental points and its report includes opposing positions, which deprives it of clarity and convincingness. 

The format of the final report from a study is closely defined and the Study Director is responsible for its production. The test item and name of the study must be clearly identified, along with the start and end date. It has to be accompanied by a statement from the Quality Assurance unit that the study and any critical aspects of the work have been conducted to the requirements of GLP principles. It will contain the names of all those involved with the study and their address this includes the Study Director, the Principal Investigator, and all the scientists... 

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