Phillip I. Good's A Manager's Guide to the Design and Conduct of Clinical PDF

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By Phillip I. Good

ISBN-10: 0471226157

ISBN-13: 9780471226154

ISBN-10: 0471251194

ISBN-13: 9780471251194

Content material:
Chapter 1 reduce charges and elevate gains (pages 1–8):
Chapter 2 instructions (pages 9–14):
Chapter three Prescription for Sucess (pages 15–18):
Chapter four Staffing for fulfillment (pages 19–28):
Chapter five layout judgements (pages 29–46):
Chapter 6 Trial layout (pages 47–54):
Chapter 7 Exception dealing with (pages 65–72):
Chapter eight Documentation (pages 73–94):
Chapter nine Recruiting and preserving Physicians and sufferers (pages 95–108):
Chapter 10 Computer?Assisted information access (pages 109–124):
Chapter eleven facts administration (pages 125–140):
Chapter 12 Are you prepared? (pages 141–144):
Chapter thirteen tracking the pains (pages 145–154):
Chapter 14 dealing with the rigors (pages 155–164):
Chapter 15 facts research (pages 165–198):
Chapter sixteen fee (pages 199–208):

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Additional resources for A Manager's Guide to the Design and Conduct of Clinical Trials

Sample text

3. 4. 5. 6. 7. 8. 9. 10. patient will receive injections for three days, self-administer a drug for six months, and attend first semiweekly and then weekly counseling sessions over the same period. How likely are these patients to comply? Keep the experimental design simple (see Chapter 6). Keep the data collected to a minimum. Pretest all questionnaires to detect ambiguities. Use computer-assisted data entry to catch and correct data entry errors as they are made (see Chapter 10). Ensure the integrity and security of the stored data (see Chapter 11).

2. 3. 4. Immediate detection and correction of errors Reduced sources of error Open-ended, readily modified forms Early detection of trends and out-of-compliance sites Data entry can be via keyboard, touch-screen, voice-recognition, or a hand-held device. 3 It is well known that the ability to correct bad data declines exponentially with the time elapsed between the observation and the correction. By providing for validation of data at the time of entry, typographical and other errors can be trapped and corrected immediately.

The project leader is responsible for authorizing payment to study physicians and other contract resource personnel (pharmacologists, CHAPTER 4 STAFFING FOR SUCCESS 25 radiologists, testing laboratories) as each individual milestone is completed. Approval is generally pro forma once the clinical research monitors report completion. The database manager has the continuing responsibility of seeing that the data are stored correctly, that data integrity are maintained and that data are readily retrievable.

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A Manager's Guide to the Design and Conduct of Clinical Trials by Phillip I. Good


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