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Reporter defined

Just as there is an adverse event form, there is usually a serious adverse event (SAE) form. Note here that serious as defined by the FDA is different from severe on the adverse event form. A patient can have a severe headache that may not be considered serious. The ICH guideline (also in ICH E3) entitled Clinical Safety Data Management Definitions and Standards for Expedited Reporting defines serious adverse events as follows ... [Pg.34]

See also CFR Web site, http //www.access.gpo.gov/nara/cfr/index.html. An August 1997 guideline, Post-Marketing Adverse Experience Reporting for Human Drug and Licensed Biological Products Clarification of What to Report, defined the minimum data relevant for a safety report as... [Pg.774]

The bidentate oxazoline ligands 85 and 86 (and derivatives thereof) are excellent reporter ligands, and several studies have used NOEs to determine the nature of their chiral pockets [61, 113, 114, 126]. NOESY studies on the cations [Ir(l,5-COD)(86)]+ and several cationic tri-nudear Ir(iii)(hydrido) compounds [110], e. g. [Ir3(p3-H)(H)5(86)3] +, 87, in connection with their hydrogenation activity, allowed their 3-D solution structures to be determined. In addition to the ortho P-phenyl protons, the protons of the oxazoline alkyl group are helpful in assigning the 3-D structure of both the catalyst precursors and the inactive tri-nudear dusters. Specifically, for one of these tri-nudear Ir(iii) complexes, 87 [110], with terminal hydride ligands at d -17.84 and d -21.32 (and a triply bridging hydride at 5 -7.07), the P-phenyl and oxazoline reporters define their relative positions, as shown in Scheme 1.5. [Pg.26]

In 1959, four independent and simultaneous reports defined the problem, van Bekkum et al. (1959), not distinguishing among the ordinary and electrophilic side-chain reactions, showed the o--constants to be broadly variable. They tabulated the a-parameters for twelve groups as derived from each reaction of an extended series. Just as illustrated in Fig. 50 for the p-methoxy, p-methyl, and p-chloro substituents, they detected extensive variations in the apparent values of the constants. The authors concluded that the postulation of two or three sets of -constants could not be regarded as sound. By eliminating all those reactions involving important resonance contributions Wepster and his associates (van Bekkum et al., 1959) obtained a series of reactions similar to those presented in Table 23, and hence derived a series of normal, an, parameters for meta and para substituents. These normal values, presumably representing the reactions for which the Hammett relationship is most precise, exhibit standard deviations of 10-30%. [Pg.143]

Retention and management of reports Define who is responsible and where the APR will be stored. [Pg.527]

In addition to meteorological data, many ships also report visual wave observations to the weather services for these reports defined rules are available (WMO, 1996). All over the world, these data are used for climatological analysis (see Section 7.1.5). However, the reports from ships are focused mainly on the much-traveled routes. The estimates of the wave heights are more reliable than those of the observed wave periods. [Pg.146]

Emissions to land the report defines waste that is classified as hazardous, and includes non hazardous waste for the first time. [Pg.168]

The first document of the SAE Fuel Cell Standards Committee to be completed was developed by the Terminology working group. J2574, Fuel Cell Terminology Report, was balloted in September 2001. It is used world wide as a reference source and foundation document for all of the Vehicle Fuel Cell Standards efforts. This report defines terminology for fuel cell powered vehicles. [Pg.601]

The production of graphene via the reduction of graphite oxide was first described by Hanns-Peter Boehm, an X-ray crystallographer, who isolated and identified a few, or even single, graphene sheets with transmission electron microscopy and X-ray diffraction in 1962 (Fig. 4.10) (Boehm et al., 1962). Boehm authored the International Union of Fhire and Applied Chemistry (lUPAC) report defining the term graphene in 1994. The production of... [Pg.142]

In 2013, AHRQ released MaArmg Health Care Safer II An Updated Critical Analysis of the Evidence for Patient Safety Practices (Shekelle et al. 2013). This report is an update of an original report Making Health Care Safe, released in 2001. These two reports define a safe practice with the following statement A Patient Safety Practice is a type of process or structure whose application reduces the probability of adverse events resulting from exposure to the healthcare system across a range of procedures. ... [Pg.276]

The report defines high risk as "high risks to the public, workers, and the environment which represent either major impacts (death permanent total disability or widespread irreversible damage to the environment) that are expected to occur within one to ten years, or intermediate impacts (significant exposures, injuries, or environmental damage) that are expect to occur at least yearly."... [Pg.179]

The term Prime Contracting has been defined and interpreted in several different ways by constractors, clients, and project financiers. The UK Goverrunent, who sponsored the Building Down Barriers report defines Prime Contracting as a... [Pg.189]

The Vinyl Instimte has published results of an intensive investigation of the fire properties of PVC electrical insulation versus numerous other materials. The report defines the critical characteristics of these materials with respect to fire... [Pg.203]

In the operational context, arrangements shall be made to ensure that the facility operator is aware at all times of the location and quantities of nuclear materials in storage and to provide the necessary reports defined within the particular Safeguards Agreement. [Pg.26]


See other pages where Reporter defined is mentioned: [Pg.166]    [Pg.428]    [Pg.651]    [Pg.181]    [Pg.40]    [Pg.508]    [Pg.503]    [Pg.173]    [Pg.409]    [Pg.648]    [Pg.545]    [Pg.81]    [Pg.301]    [Pg.110]    [Pg.62]    [Pg.55]    [Pg.687]    [Pg.1626]    [Pg.703]    [Pg.35]    [Pg.325]    [Pg.284]    [Pg.277]    [Pg.648]    [Pg.19]    [Pg.110]   
See also in sourсe #XX -- [ Pg.567 ]




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