Quality Control in Clinical Trials

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3. Easier to exclude data if reason for extreme value is known 4. Prudent judgment should prevail VI. Bias in Clinical Trials: Special Issues in QC A. Minimal requirements for a bias-free RCT 1. Establish comparable study groups which are free of selection bias
2. Use standard treatment procedures which are reproducible 3. Develop data collection schedule where probability of observing an event, given that it has occurred, is the same for all patients B. Standardization as a means of bias control 1. Manual of operations 2. Description of treatment procedure 3. Standard definitions
Page 1 and 2: QUALITY CONTROL IN CLINICAL STUDIES
Page 3 and 4: I. Need for Quality Control (after
Page 5 and 6: C. Inaccurate or imprecise data 1.
Page 7 and 8: II. Quality Control of Clinical i l
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: 2. Outlier test (Tukey) a. Rank dat
Page 29 and 30: 6. Questionnaire to check on effica

Quality Control in Clinical Trials

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