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In the UK, although some data are already available, the Protocol will require additional monitoring.
For network administrators who do implement Google Talk into their network but require additional monitoring capabilities for liability concerns and regulatory compliance, there are a number of solutions available.
This approach could create significant problems in the case of insulin, in which any change in therapy might require additional monitoring, a change in the delivery device, re-training etc.
On the benefit side of the equation, the impact of extending the time period is unclear as RSA may improve quality of life in the short term but lead to a quicker deterioration once revisions are necessary, or require additional monitoring or revisions by virtue of its 'MOM' nature.
Given that retreatment with dexamethasone IVT may well occur after 4 months in clinical practice, rather than 6 months as in the GENEVA studies [ 40], the incidence of elevated IOP and cataract with dexamethasone IVT may well be higher in routine practice and is likely to require additional monitoring [ 56- 58].
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A pause occurs when a clinician recognizes a potential change in patient condition that requires additional monitoring or investigation.
We reserve the term "adverse event" for the subset of adverse occurrences where the patient experiences harm or requires additional monitoring or intervention [ 20].
The FDA is also requiring additional monitoring, including blood draws at additional timepoints after administration of study agent for complete blood counts, serum chemistry, vector DNA, TNFR Fc protein and potential T-cell responses to AAV2 capsid.
We used the IHI GTT definition for harm: unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment or hospitalisation, or that resulted in death.
15 Harm in this context is defined as an 'Unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment or hospitalisation, or that results in death'.
However, if the medication is altered or adjusted during the episode of care, or the patient requires additional monitoring or nursing care, then the condition should be coded [ 16].
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