Status of treatment blind
If yes, complete date, time and reason blind was broken.
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If blind was broken.
date
If blind was broken.
time
If blind was broken. If Z = other, please specify in item "other reason blind broken, specify". Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.
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other reason blind broken
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PGx-Pharmacogenetic Research
If yes, please give the date. If the question is answered No, pick one reason and do not complete the remainder of the page. should be completed at any time between Visits Screening and Follow-up
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If Yes in the item "consent for PGx-pharmacogenetic research", record the date informed consent obtained for PGx-Pharmacogenetic research
date
if no in the item "consent for PGx-pharmacogenetic research", pick one reason. If Z = other, specify in the "other reason, specify" item.
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If Z = other reason was picked in the item "Reason for no consent for pharmacogenetic research", please specify.
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If yes, record the date sample taken.
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If a blood sample was taken for pharmacogenetic research.
date
Must be completed immediately, if the subject withdraws consent. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom informed consent was obtained for PGx-Pharmacogenetic research. If consent is withdrawn, a request for destruction must be made and Blood Sample Destruction section completed.
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Must be completed immediately if there is a request for sample destruction. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom a blood sample was obtained for PGx-Pharmacogenetic research. If the question is answered Yes, pic one reason.
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If yes in the item "blood sample destruction", please pick one reason. If Z = other reason, specify in the item "other reason for blood sample destruction".
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If Z = other reason in item "reason for blood sample destruction", specify.
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Concomitant Medication
If Yes, fill in each item for each medication using Trade Names where possible.
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Trade name preferred. Ensure that the spelling of the Drug Name(s) is correct.
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Unit Dose
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Units
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Frequency
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Route
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Ensure that the ’Reason for Medication’ is recorded on one of the following pages using the same terms: * Current Medical Conditions * Non-Serious Adverse Events * Serious Adverse Events Form
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Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.
date
Start Time
time
Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.
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Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.
date
Stop Time
time
Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.
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Pregnancy Information
Study Conclusion
If subject completed study: "Date of subject completion or withdrawal" must match the last scheduled study visit date. If subject withdrew and a withdrawal visit was conducted: "Date of subject completion or withdrawal" must match the date of subject withdrawal. If subject lost to follow-up: "Date of subject completion or withdrawal" must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.
date
Time of withdrawal
time
If Yes, pick the primary reason for withdrawal in the item "Reason for withdrawal"
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If the investigational product was discontinued at the same time as the subject was withdrawn from the study, ensure the reasons for the two discontinuations are consistent. Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. If the subject was withdrawn due to an adverse event, confirm that details recorded correspond with details on the Adverse Event: * ’Withdrawal’ on the AE/SAE page is recorded as ’Yes’. * ’Action Taken with Investigational Product(s) as a Result of the Non-Serious AE/SAE’ on the AE/SAE page is recorded as ’Investigational Product Withdrawn’. * ’Primary Reason for Withdrawal’ on the Study Conclusion page is recorded as ’Adverse Event’. If Z = other is picked, please fill in the item "other reason for withdrawal"
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Other Reason for withdrawal
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Investigator Comment Log
CRF page number
integer
Only use this form to record explanatory information on anomalies such as missing data, sponsor waiver of inclusion/exclusion criteria, departures from planned investigational product administration or missed visits.
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Investigator's signature
The Investigator is accountable for CRF data. However, the Principal Investigator may delegate CRF signature authority to a medically qualified Sub-investigator (as indicated on the Site Staff Signature Sheet).
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Date of signature
date
Investigator's name
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