Quality Control in Clinical Trials

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3. Less often but more concerning are systematic differences in measurement techniques associated with participant characteristics: obese or unfit persons allowed to hold hand rails in exercise testing; persons with emphysema permitted to shorten exhalation time in spirometry testing
II. Quality Control of Clinical i l Procedures A. Steps that precede study 1. Develop manual of operations a. Clear operational definitions of eligibility, recruitment, measurement procedures b. Standardized instruments and forms c. Approaches to analyzing data 2. Train and certify research team 3. Establish procedures for monitoring data quality
Page 1 and 2: QUALITY CONTROL IN CLINICAL STUDIES
Page 3 and 4: I. Need for Quality Control (after
Page 5: C. Inaccurate or imprecise data 1.
Page 9 and 10: LIFE Components Requiring Certifica
Page 11 and 12: Certification/Recertification Check
Page 13 and 14: 6. Maintain minimum schedule of per
Page 15 and 16: 1. Patient safety a. Consent forms
Page 17 and 18: . Tissue diagnosis of cancer: dupli
Page 19 and 20: B. Program computer to flag missing
Page 21 and 22: V. Data editing A. Should be comple
Page 23 and 24: . Missing values (find out why miss
Page 25 and 26: 2. Outlier test (Tukey) a. Rank dat
Page 27 and 28: 2. Use standard treatment procedure
Page 29 and 30: 6. Questionnaire to check on effica

Quality Control in Clinical Trials

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