Recommendations section, report document

It has already been recommended (Section 4) that a verification and validation plan be prodnced at an early stage of the project. This plan should define the set of verification and analysis techniques to be used, should provide justification that this set will give sufficient evidence and should define the particular records, reports and documents that will be prepared. The plan should also cover the management issues of who will perform each process and how these processes will be coordinated with each other and with the development processes. 

The first, the PrHA report, contains all necessary information except for a "...system to promptly address the team s findings and recommendations assure that the recommendations are resolved in a timely manner and that the resolution is documented ..." That information is separately documented, as discussed in Section 6.0 of this handbook. Two useful references on the documentation of PrHAs are Freeman, 1991 and Hendershot, 1992. 

Before a clinical trial starts, the use of technical aids such as IVRT, remote data entry and electronic diaries has to be considered. In Section 7.5.3.3, mention will be made of the use of electronic tracking system that provide status and monitoring reports. All these systems utilise computer systems that must be validated. Double and McKendry described computer validation as the process which documents that a computer system reproducibly performs the functions it was designed to do. The document Guidance for Industry - Computerised Systems used in Clinical Trials published by the FDA in 1999 gives clear recommendations of what is required (also see Section 7.5.4.1). 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

In this section we describe problems that users of equipment and computer frequently experience during validation and qualification. Problems have been either reported to the author during seminar or conference discussions or have been documented by the FDA in inspection reports and warning letters [22]. In this section we also give recommendations on how to avoid the problems or to resolve them if they occur. 

Results. The results section is where findings are documented for each analysis. Although the acceptance criteria or specifications are listed in Section I, it is a good idea to capture the acceptance criteria in the area(s) in which the results will be listed, as shown in the next table. It is recommended that the original data be kept within the responsible or analyzing department and that the results be transcribed by the reporting laboratory to the protocol data sheets. If the need arises to compare these two sources, they could be retrieved from the data files of the responsible department. 

Like chabazite, clinoptilolite has been used as a cheap desiccant and molecular sieve. As noted earlier, its selectivity for Cs has led to its use in aqueous nuclear waste treatment and its ability to remove NH4+ from water has been used on a plant scale (see Section. 5.3.2). An extensive literature describes its use in horticulture and agriculture as an amendment to soils and composts. Similarly, the benefits of its addition to animal feeds is well documented. These uses have been reviewed and three conference reports also can be recommended for further details. " ... 

A9.6.4.7 The Nordic Council of Ministers issued a report (Pederson et al, 1995) entitled Environmental Hazard Classification, that includes information on data collection and interpretation, as well as a section (5.2.8) entitled QSAR estimates of water solubility and acute aquatic toxicity . This section also discusses the estimation of physicochemical properties, including log Kow For the sake of classification purposes, estimation methods are recommended for prediction of minimum acute aquatic toxicity, for ...neutral, organic, non-reactive and non-ionizable compounds such as alcohols, ketones, ethers, alkyl, and aryl halides, and can also be used for aromatic hydrocarbons, halogenated aromatic and aliphatic hydrocarbons as well as sulphides and disulphides, as cited in an earlier OECD Guidance Document (OECD, 1995). The Nordic document also includes diskettes for a computerized application of some of these methods. 

NDA preparation requires extensive planning and coordination among authors to ensure consistency and completeness of the dossier. Analytical data are the common thread in all CMC documents and are highly intertwined with other reports in the CMC section. Documents related to biobatches also need to be integrated between the CMC and clinical sections of the NDA. The value of cross-functional review of documents cannot be overemphasized. If possible, review of the complete CMC section by the CMC team or an independent technical reviewer is highly recommended. 

I have provided your supervisors with copies of a document on MSDSs that should be very helpful as you proceed in this work. It is a section entitled Exploring MSDSs found in the book Building Student Safety Habits for the Workplace, published by Terrific Science Press at the Center for Chemical Education at Miami University, Middletown, OH. This section includes a set of instructions for doing exactly what is required for this project (Exercise 3B). I also have made photocopies of the labels in question (found in Section 2B in the above referenced book) and the MSDSs (found in Section 3B in the above referenced book). Also, your supervisors will decide who should evaluate which labels. I have recommended that each participant be assigned two of the four chemicals (four labels) at random, meaning that each participant will each have four labels to evaluate, a consumer product label and an industrial chemical product label for one chemical and a consumer product label and industrial chemical product label for a second chemical. Please use the method suggested for Exercise 3B in the book referenced above and keep a good record of your work in your notebook so that you can prepare a quality report memo for WSHA. 

The executive summary serves to brief a reader on the salient points in the report without requiring detailed scrutiny of the rest of the document. The summary will typically contain a view on the overall clinical risk profile and acceptability along with any outstanding issues or constraints on the assessment. Key claims and recommendations may also be iterated in this section to round off the summary. 

The overall process of EOP validation and its documentation should be reviewed according to the recommendations in Section 3.6. The review should focus on whether the validation guide has been properly developed and applied. A detailed validation review should be carried out for a representative sample of procedures based on the validation report. It is convenient to select those procedures which have been reviewed in-depth as described in Section 4.5.4. 

One of the provisions in this section recommends that suppliers of equipment, technologies, processes and materials provide documentation establishing that a risk assessment has been conducted and that an acceptable risk level, as outlined by the procuring organization, has been achieved. Addendum D is an example of a basic Risk Assessment Report that can be used as a guide for that purpose. 

The use and safety of intralesional cidofovir for RRP was also investigated by another team, using a cross-sectional survey [3 ]. The survey was distributed to 82 surgeons, who collectively had managed 1248 RRP patients (including 447 children) in the previous lOyears. Adverse events reported by respondents included dysplasia (75 and 8, adults and children respectively), squamous cell carcinoma (14 and 3), acute kidney injury (0 and 5), and death (1 and 3). The authors recommend that when cidofovir is used in this context, there should be a documented discussion with patients of the risks versus the benefits and also that informed consent should be obtained for this off-label usage, with mention of risk of acute kidney injxuy in children. 

A dynamic analysis of record was performed by United Engineers Constructors (UE C) for the SSS in the K-Reactor building. The UE C report, which is preliminary, documents the seismic analysis of the Far Side SSS piping for the K-Reactor. The 1983 B31.1 code was used in this analysis supplemented by the 1983 ASME Section III, Subsection NC for flanges. The faulted limits were used. UE C concluded, as a result of the analysis, that the Far Side SSS for the K-Reactor meets the specified stress criteria provided that recommended support modifications are made to the supporting system. By similarity, UE C concluded that the Near Side SSS for the K-Reactor also meets the specified stress criteria provided that similar modifications are made in accordance with UE C recommendations. 

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