ࡱ>  sbjbj ܩ 1t-$W7Q5555T h66666669;.6]!r"!!655=7f#f#f#!556f#!6f#f#44|e@550U+X,!46'70W74;H!;$55";5!!f#!!!!!66,#:!!!W7!!!!;!!!!!!!!! :  Decision Summary Meeting Date FORMTEXT      Application # FORMTEXT      Title of TCP FORMTEXT       FORMCHECKBOX  New TCP  FORMCHECKBOX  Substitute/replacement for existing  FORMCHECKBOX  Extended use of existing  FORMCHECKBOX  Other FORMTEXT      Conflict of Interest declarationApplicant  FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMTEXT      Committee  FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMTEXT      SAFETY FORMCHECKBOX  Safer than current practice FORMCHECKBOX  Equivalent to current practice FORMCHECKBOX  Less safe than current practice  FORMTEXT      EFFECTIVENESSHigh quality evidence? FORMTEXT      Consistent, clinically important benefit? FORMTEXT      Applicable to Southern Health? FORMTEXT       FORMTEXT      COST FORMTEXT      CLINICAL FEASIBILITYResource implications FORMTEXT      Credentialing and competency assurance undertaken FORMTEXT       FORMTEXT      ISSUES RELATED TO ACCESS & EQUITY AND LEGAL & ETHICAL IMPLICATIONS FORMTEXT      Final decision by the Southern Health Technology/Clinical Practice Committee FORMCHECKBOX Recommended: Approved with no further need for assessment. FORMCHECKBOX Restricted Recommendation Audit: Approval subject to implementation under audit conditions. Conditions are specific to the technology. FORMCHECKBOX Restricted Recommendation Clinical Trial: Endorsed, however approval subject to implementation in clinical trial with Southern Health Human Research and Ethics Committee approval. FORMCHECKBOX Restricted Approval Operational Restrictions: Endorsed, however financial or operational restrictions apply. FORMCHECKBOX Not RecommendedGeneral Conditions The Head of Department/Unit is required to notify the Secretariat of TCPC in the event of: Any change in protocol and the reason for that change together with an indication of ethical implications Adverse effects of the TCP and steps to deal with them Any unforeseen events Adverse Events If an adverse event occurs the Head of Department/Unit must immediately notify the TGA in addition to the TCPC. 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