Study Conclusion
If Yes, tick the primary reason for withdrawal
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Adverse Event: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. If subject did not meet treatment eligibility criteria, ensure ’Clinically significant screening lab values’ and/or ’Clinically significant screening ECG abnormalities’ are ticked.
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Other Specification
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Investigator Comment Log
CRF Page Number
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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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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
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Investigator's Name
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