Protocol-study-profile-example

id: study,

extension: http://example.org/example-do-not-use/Profilestudyprotocol#arm arm-dose1,

extension: http://example.org/example-do-not-use/Profilestudyprotocol#arm arm-dose2,

extension: http://example.org/example-do-not-use/Profilestudyprotocol#epoch epoch-screening,

extension: http://example.org/example-do-not-use/Profilestudyprotocol#epoch epoch-single-blind-run-in,

extension: http://example.org/example-do-not-use/Profilestudyprotocol#epoch epoch-treatment-phase,

extension: http://example.org/example-do-not-use/Profilestudyprotocol#epoch epoch-follow-up,

status: active,

type: study,

purpose: Defines the execution of study AD-4833PNFP-341,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: SCRN, description: Screen, precondition: , description: Informed Consent, exit: , description: Screening assessments complete,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armAssignment, name: SBRI, description: Single Blind Run-In, duration: , value: 1, system: http://unitsofmeasure.org, code: wk, precondition: , description: Initial Single Blind Placebo dose, exit: , description: 1 week after start of Element,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: DOSE 1, description: Administer 0.5mg [Drug A] QD, duration: , value: 30, system: http://unitsofmeasure.org, code: wk, precondition: , description: First dose of treatment where total drug dose of [Drug A] per day is 0.5 mg., exit: , description: 30 weeks after start of Element,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: FLWUP, description: Follow-Up, precondition: , description: Last dose of treatment, exit: , description: 2 weeks after start of Element,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: SCRN, description: Screen, precondition: , description: Informed Consent, exit: , description: Screening assessments complete,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armAssignment, name: SBRI, description: Single Blind Run-In, duration: , value: 1, system: http://unitsofmeasure.org, code: wk, precondition: , description: First dose of Single Blind Placebo, exit: , description: 1 week after start of Element,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: 1.0 mg Dose, description: Administer 1.0 mg [Drug A] QD, duration: , value: 30, system: http://unitsofmeasure.org, code: wk, precondition: , description: Intial dose of treatment where total drug dose of [Drug A] per day is 1.0 mg., exit: , description: 30 weeks after start of Element,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: FLWUP, description: Follow-Up, precondition: , description: Last dose of treatment, exit: , description: 2 weeks after start of Element,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: VISIT 1, precondition: , description: Screening, activity: , detail: , category: encounter,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: VISIT 2, precondition: , description: single-blind placebo start, activity: , detail: , category: encounter,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: VISIT 3, precondition: , description: Treatment start, activity: , detail: , category: encounter,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: VISIT 4, precondition: , description: 5 weeks after treatment start, activity: , detail: , category: encounter,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: VISIT 5, precondition: , description: 10 weeks after treatment start, activity: , detail: , category: encounter,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: VISIT 6, precondition: , description: 15 weeks after treatment start, activity: , detail: , category: encounter,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: VISIT 7, precondition: , description: 20 weeks after treatment start, activity: , detail: , category: encounter,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: VISIT 8, precondition: , description: 25 weeks after treatment start, activity: , detail: , category: encounter,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: VISIT 9, precondition: , description: 30 weeks after treatment start, activity: , detail: , category: encounter,

step: , extension: http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, name: VISIT 10, precondition: , description: start of follow-up, activity: , detail: , category: encounter,