Quality Control in Clinical Trials

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III. Identifying appropriate data for quality control A. Cost of controlling everything is prohibitive B. May need less attention in blinded, randomized clinical trials as random errors should be distributed evenly between treatment groups C. Focus on patient t safety factors, key exposure variables, and outcome measures
1. Patient safety a. Consent forms and consent process b. Integrity of randomization scheme c. Effects and side-effects of treatment (blood pressure in antihypertensive trial, coagulation measures in anticoagulation trial, etc.) d. Drug administration (correct drug and dosage, correct code on participant bottle)
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: 6. Maintain minimum schedule of per
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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