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Practical Study Management IWRSPractical Study Management IWRSPractical Study Management IWRSPractical Study Management IWRS

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Screening and EligibilityScreening and Eligibility

1. Screening and Screen Failure Transactions

Interactive Web Response System (IWRS)

Study Timeline

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Record screening

immediately after informed

consent signature

Acknowlege Receipt of

Study Drug – Quarantine if Temperature Out of Range

occured

Record screen failures

(discontinuation)

IWRS Worksheets - Screening

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RandomizationRandomization

1. Randomization and Treatment Transactions

Interactive Web Response System (IWRS)

Study Timeline

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Record screening

immediately after informed

consent signature

Acknowlege Receipt of

Study Drug – Quarantine if Temperature Out of Range

occured

Record Randomisation

Treatment Group is assigned (Blinded)

Record screen failures

(discontinuation)

IWRS Worksheet - Randomization

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Ensure to enter correct MIPI score to avoid stratification error

eCRF: Randomization

• Randomization date and Randomization number will be automatically populated by IWRS.

• Treatment assignment will be dictated by IWRS.

• As soon as the treatment is assigned, Cycles 1 to 6 and the End-of- Treatment Visit will dynamically appear in the visit structure.

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randomization

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Treatment PhaseTreatment Phase

1. Treatment Transactions

Interactive Web Response System (IWRS)

Study Timeline

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Record screening

immediately after informed

consent signature

Acknowlege Receipt of

Study Drug – Quarantine if Temperature Out of Range

occured

Record Randomisation

Treatment Group is assigned (Blinded)

RecordStudy Visits

Day 1 of each Dosing Cycle

Unscheduled Study Visit

(after Day 1 Cycle 1 is recorded)

Record screen failures

(discontinuation)

Dispensing of study medications will be IWRS-controlled

IWRS – Study Visits Worksheets

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Treatment DiscontinuationTreatment Discontinuation

1. Discontinuation Transaction

Interactive Web Response System (IWRS)

Study Timeline

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Record screening

immediately after informed

consent signature

Acknowledge Receipt of

Study Drug – Quarantine if Temperature Out of Range

occurred

Record Randomization

Treatment Group is assigned (Blinded)

RecordStudy Visits

Day 1 of each Dosing Cycle

Unscheduled Study Visit

(after Day 1 Cycle 1 is recorded)

Record Subject Discontinuation:1) End of Treatment

2) End of Efficacy follow-up3) End of Study

Record screen failures

(discontinuation)

IWRS – Discontinuation Worksheet

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