1 practical study management iwrs. 2 screening and eligibility
TRANSCRIPT
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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
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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)
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IWRS Worksheets - Screening
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RandomizationRandomization
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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)
![Page 7: 1 Practical Study Management IWRS. 2 Screening and Eligibility](https://reader035.vdocument.in/reader035/viewer/2022070410/56649f125503460f94c25bfe/html5/thumbnails/7.jpg)
IWRS Worksheet - Randomization
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Ensure to enter correct MIPI score to avoid stratification error
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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
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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
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IWRS – Study Visits Worksheets
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Treatment DiscontinuationTreatment Discontinuation
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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)
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IWRS – Discontinuation Worksheet
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