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SIPOC templates

SIPOC — Clinical Trial Site Activation

Bounds phase III site start-up at seven steps from site qualification to first patient screened, with three of its six inputs carrying a stated requirement and the 137-day activation cycle measured against a 90-day target.

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Clinical trial site activation — phase III oncologyScope · Site selected → First patient screenedProcess ownerStudy start-up lead, EU …Site activation cycle137target 90 · +47 daysSites activated per month3.5target 6 · -2.5Protocol deviations in month one2target 0 · +2SSuppliers4IInputs6PProcess7OOutputs4CCustomers4Sponsor study teamCentral ethics committeeContract research organisationCentral laboratoryApproved protocolInvestigator brochureSigned clinical trial agreementCTQFully executed by sponsor andinstitution before activationEthics approval letterCTQCovers the current protocol versionand every site documentDelegation of authority logInvestigational productshipmentFree of temperature excursions,accountability log receivedActivation memoTrained and delegated sitestaffCTQEvery delegated task signed beforefirst patient contactReleased drug supplySite initiation visit reportFiled in the trial master fileinside 10 working daysPrincipal investigatorStudy participantsSponsor operationsRegulatory authorities1Qualify site2Negotiatebudget andcontract3Submit toethics4Train sitestaff5Releaseinvestigationalproduct6Activate site7Screen firstpatient4 suppliers · 6 inputs · 7 process steps · 4 outputs · 4 customers3 of 6 inputs have no stated requirement: “Approved protocol”, “Investigator brochure”, “Delegation of authority log”.2 of 4 outputs have no stated requirement: “Activation memo”, “Released drug supply”.Scope starts at “Site selected”, matching step 1 “Qualify site”.Scope ends at “First patient screened”, matching the last step “Screen first patient”.Metric “Site activation cycle” misses target: 137 against 90, a gap of 47 days.Metric “Sites activated per month” misses target: 3.5 against 6, a gap of 2.5.Metric “Protocol deviations in month one” misses target: 2 against 0, a gap of 2.

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title "Clinical trial site activation — phase III oncology"
scope "Site selected" -> "First patient screened"
owner "Study start-up lead, EU region"
metric "Site activation cycle" target: 90 actual: 137 unit: days
metric "Sites activated per month" target: 6 actual: 3.5 better: higher
metric "Protocol deviations in month one" target: 0 actual: 2

suppliers: Sponsor study team, Central ethics committee, Contract research organisation, Central laboratory
inputs: Approved protocol, Investigator brochure, Signed clinical trial agreement, Ethics approval letter, Delegation of authority log, Investigational product shipment
process steps: Qualify site -> Negotiate budget and contract -> Submit to ethics -> Train site staff
               -> Release investigational product -> Activate site -> Screen first patient
outputs: Activation memo, Trained and delegated site staff, Released drug supply, Site initiation visit report
customers: Principal investigator, Study participants, Sponsor operations, Regulatory authorities

requirement input "Signed clinical trial agreement": "Fully executed by sponsor and institution before activation" (CTQ)
requirement input "Ethics approval letter": "Covers the current protocol version and every site document" (CTQ)
requirement input "Investigational product shipment": "Free of temperature excursions, accountability log received"
requirement output "Trained and delegated site staff": "Every delegated task signed before first patient contact" (CTQ)
requirement output "Site initiation visit report": "Filed in the trial master file inside 10 working days"