Condition Condition The Medical Valid values Providing transparency The linkage of clinical Risk to assessing Use Transparent to – – Condition for of condition requiring outcome data to incorrect dose and some users of system Conditions as which treatment is a critical condition and infusion plan at (see security matrix). defined in the treatment is element needed for prescribed treatment authorisation resulting Criteria No disclosure other being accurate Authorisation is essential for in potential ineffective than at level of requested. of proposed patient ongoing evidence clinical outcome, aggregated treatment as dose, base and determining inappropriate product reports for clinical frequency and the efficacy of Ig and dose/schedule of governance and Ig treatment schedule is treatment. (NBA, treatment, determining governance purposes. different for different Hospital) efficacy of treatment conditions and and inability to demand indications. forecast and secure sufficient product (NBA, Hospital, supply. Authoriser,) NBA - 3 Specific Specific The specific Providing transparency The linkage of clinical Risk to assessing Use Transparent to – Condition Condition condition (as a of condition requiring outcome data to incorrect dose and some of system subset of the treatment is a critical condition and infusion plan at (see security matrix). Condition) for element needed for prescribed treatment authorisation resulting No disclosure which accurate Authorisation is essential for in potential ineffective than at level of treatment is of proposed patient ongoing evidence clinical outcome, aggregated being requested treatment as dose, base and determining inappropriate product reports for clinical frequency and the efficacy of Ig and dose/schedule of governance and Ig treatment schedule is treatment. treatment, determining governance purposes. different for different efficacy of treatment and inability to demand
Condition Condition The Medical Condition for which treatment is being requested. Valid values – Conditions as defined in the Criteria Providing transparency of condition requiring treatment is a critical element needed for accurate Authorisation of proposed patient treatment as dose, frequency and treatment schedule is different for different conditions and indications. (NBA, Hospital, Authoriser,) NBA - 3 The linkage of clinical outcome data to condition and prescribed treatment is essential for ongoing evidence base and determining the efficacy of Ig treatment. (NBA, Hospital) Risk to assessing incorrect dose and infusion plan at authorisation resulting in potential ineffective clinical outcome, inappropriate product and dose/schedule of treatment, determining efficacy of treatment and inability to demand forecast and secure sufficient product supply. Use – Transparent to some users of system (see security matrix). No disclosure other than at level of aggregated reports for clinical governance and Ig governance purposes. Specific Condition Specific Condition The specific condition (as a subset of the Condition) for which treatment is being requested Providing transparency of condition requiring treatment is a critical element needed for accurate Authorisation of proposed patient treatment as dose, frequency and treatment schedule is different for different The linkage of clinical outcome data to condition and prescribed treatment is essential for ongoing evidence base and determining the efficacy of Ig treatment. Risk to assessing incorrect dose and infusion plan at authorisation resulting in potential ineffective clinical outcome, inappropriate product and dose/schedule of treatment, determining efficacy of treatment and inability to demand Use – Transparent to some of system (see security matrix). No disclosure than at level of aggregated reports for clinical governance and Ig governance purposes.
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