End of Study Record
day month year. Check that the "Date of subject completion or discontinuation from the study" is on or after the last treatment stop date on the INVESTIGATIONAL PRODUCT page.
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00:00-23:59. Check that the "Time of subject completion or discontinuation from the study" is the same as or after the time of last treatment dose (if applicable) on the INVEST/GA TIONAL PRODUCT page if present.
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Tick one. This question must be answered for all subjects. For females not of childbearing potential or males, tick NOT APPLICABLE. If no pregnancy was known before a subject was lost to follow-up, tick NO. If the subject became pregnant before either premature discontinuation from the study or completion of the study, tick YES. If you tick YES, record details on PREGNANCY NOTIFICATION FORM.
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The medical devices being used in this study are the VOLUMATIC spacers. If a subject never used this/these device(s), tick NO. If no incident was known before a subject was lost to follow-up, tick NO. If an incident occurred before either premature discontinuation from the study or completion of the study, tick YES. If you tick YES, record details on the MEDICAL DEVICE INCIDENT REPORT FORM.
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Subjects who complete all study visits (screening, all treatment periods and follow-up) will be considered as having completed the study.
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Tick one. If A: Record details on NON-SERIOUS ADVERSE EVENTS or SERIOUS ADVERSE EVENT page as appropriate.
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Other reason
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Investigator Comment Log
Date of comment
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CRF page number
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Comment
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Investigator’s Statement
I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
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day month year
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Investigator’s signature
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Investigator’s name - print
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