Outline

1
Outline

• Case Status Types
• Data Submission
• Eligibility Types
• Withdrawal of Consent

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Case Status

• Case status has two parts
• Data submission requirements
• Eligibility status

Open - Eligible
Eligibility status
Data submission
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Data Submission

• Open status
• Requires data submission per patient calendar
• Closed status
• Requires no further data submission
• Change to Closed is generally due to patient death

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Eligibility Types

• Eligible
• Ineligible
• No Protocol Treatment
• Pending

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Eligible

• Eligibility requirements met
• Patient has received treatment
• Default status
• Case status Open Eligible

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Ineligible

• Eligibility requirement(s) not met
• Phase III Studies
• Patients will continue to be followed per
  protocol
• Case status Open Ineligible
• Phase I or II Studies
• No further data submission is necessary once
  ineligibility is confirmed and all outstanding
  data on the patient calendar has been received
• Case status Closed Ineligible

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No Protocol Treatment

• Patient did not receive ANY protocol treatment
• Phase III Studies
• Patients will continue to be followed per
  protocol
• Case status Open No Prot RX
• Phase I or II Studies
• Case will be closed once I1 is received
• Case status Closed No Prot RX

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Pending

• Patient appears to be ineligible
• HQ sends institution query
• Institution answers query in a timely fashion
• If response not received within 6 months
• The case is made ineligible
• Response can still be sent
• Eligibility status can be changed back to
  eligible
• Submit data as usual (regardless of Phase)
• Case status Open Pending

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Withdrawal of Consent

• Patient has right to withdraw consent at any time
  and for any reason
• Withdrawal of consent does not apply in the
  following situations
• Patient refuses protocol treatment at any time
• Patient does not want to come back for follow up
• Patient leaves institution

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Withdrawal of Consent

• HQ must receive proper notification via CW form
  to close case and suppress further data
  collection
• Once all outstanding data is received, the case
  will be closed
• Case status Closed Eligible

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Withdrawal of Consent
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Withdrawal of Consent
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CW Form Instructions
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CW Form
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CW Form

• Signed or initialed by the patient
• Witnessed by an institutional staff member or
  third party
• Signed by the PI

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Questions?