Data Clarification Form (Dcf)

Data Clarification Form (Dcf)

<p> DATA CLARIFICATION FORM (DCF) <Name of STUDY> Protocol No: NCT-2198-LM Country: RDC Site: Kinshasa PI name: Dr Makata Originator: Yves Claeys Date written: 21/12/2012 DCF No: 4 Patient Number: 12003 Patient initials: LT</p><p>CRF page Question Response 23 Hemocue result 3,5 g/dl Hemocue result is typo: correct value The lab result is out of range. Please is 7,5. The result is not clinical confirm clinical significance significant</p><p>54 Stopdate (12/10/2012) is before start Correct stop date is 12/12/2012 date (15/11/2012) for AE ‘Headache’. Please check and correct if needed</p><p>1. Respond to the question in the response box to the right 2. Sign and date this form 3. Attach a copy to the patients’ CRF on site 4. Return the original DCF back to Data Management within 72h</p><p>Return address: [email protected] Changes authorized by Signature Date </p><p>Dr Makata X 23/12/2012</p><p>ADMIT-009-02-Example-Data Clarification Form Page 1 of 1 Version 1.0 10-JAN-2013</p>

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