FDA Guidance Documents
Draft Guidance on the Qualification of the EXACT for the Measurement of Symptoms of Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease.
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Draft Guidance on Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use.
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Guidance for Industry on Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease.
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Guidance for Industry on Qualification Process for Drug Development Tools.
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EMA Guidance Documents
Draft Qualification Opinion of Qualification of Exacerbations of Chronic Pulmonary Disease Tool (EXACT), and EXACT-Respiratory Symptoms Measure (E-RS) for Evaluating Treatment Outcomes in Clinical Trials in COPD.
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Draft Qualification Opinion of Qualification of Exacerbations of Chronic Pulmonary Disease Tool (EXACT), and EXACT-Respiratory Symptoms Measure (E-RS) for Evaluating Treatment Outcomes in Clinical Trials in COPD.
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Draft Qualification Opinion of Qualification of Exacerbations of Chronic Pulmonary Disease Tool (EXACT), and EXACT-Respiratory Symptoms Measure (E-RS) for Evaluating Treatment Outcomes in Clinical Trials in COPD.
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Draft Qualification Opinion of Qualification of Exacerbations of Chronic Pulmonary Disease Tool (EXACT), and EXACT-Respiratory Symptoms Measure (E-RS) for Evaluating Treatment Outcomes in Clinical Trials in COPD.
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Good Research Practices
Recently published ISPOR Good Practices for Outcomes Research
ISPOR PRO Task Force: Good Research Practices on Use of Existing Instruments and Their Modification.
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ISPOR PRO Task Force: Good Research Practices on Changing Culture or Language of an Application.
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ISPOR PRO Task Force: Good Research Practices on Changing the Mode of Administration / ePRO.
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Trials Using the EXACT® or E-RS™
