Quality Control in Clinical Trials Blinding, Clinical ... - summitMD.com
Quality Control in Clinical Trials Blinding, Clinical ... - summitMD.com
Quality Control in Clinical Trials Blinding, Clinical ... - summitMD.com
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• Dur<strong>in</strong>g the study<br />
Bl<strong>in</strong>d<strong>in</strong>g<br />
• Use different site personnel (Investigator and Site<br />
Coord<strong>in</strong>ator) to perform the procedure vs. the follow-up<br />
so the treatment will rema<strong>in</strong> bl<strong>in</strong>ded dur<strong>in</strong>g the follow-up<br />
• Develop a script for follow-up personnel to use <strong>in</strong><br />
obta<strong>in</strong><strong>in</strong>g <strong>in</strong>formation from patients<br />
• Tra<strong>in</strong> follow-up personnel to avoid sections of the<br />
patient’s record that would cause unbl<strong>in</strong>d<strong>in</strong>g<br />
• <strong>Control</strong> <strong>com</strong>munication channels<br />
• Who can send and/or receive <strong>in</strong>formation<br />
• By what methods (phone, email, reports, letters) and<br />
password protection<br />
• What <strong>in</strong>formation can be provided by each method
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