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Page 1 of 13Endoscopy video recording guidance Trial Title:A randomized, multigenre, biomarker stratified, open label trial in patients newly diagnosed with Crohn's disease. REC Reference:17/EE/0382IRAS
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Efficacy and safety refer to the ability of a treatment or intervention to produce desired outcomes without causing unacceptable adverse effects.
Manufacturers, sponsors, or researchers of pharmaceuticals, medical devices, or treatment protocols are required to file reports on efficacy and safety.
Filling out efficacy and safety reports typically involves collecting clinical trial data, completing required templates or forms, and providing comprehensive information about the study design, results, and any observed side effects.
The purpose is to ensure that health interventions are effective for their intended use and to assess any potential risks associated with their use.
Reports must include data on clinical outcomes, side effects, patient demographics, trial methodology, and any significant findings related to efficacy and safety.
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