By Phillip I. Good
Chapter 1 lower bills and elevate earnings (pages 1–8):
Chapter 2 guidance (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 holding Physicians and sufferers (pages 95–108):
Chapter 10 Computer?Assisted information access (pages 109–124):
Chapter eleven information administration (pages 125–140):
Chapter 12 Are you prepared? (pages 141–144):
Chapter thirteen tracking the rigors (pages 145–154):
Chapter 14 dealing with the pains (pages 155–164):
Chapter 15 information research (pages 165–198):
Chapter sixteen cost (pages 199–208):
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Extra resources for A Manager's Guide to the Design and Conduct of Clinical Trials
H. Train. Three topics should be covered in a training program for the investigators and their staffs. See Chapter 10. 1. Details of the intervention. The procedures manual developed in Chapter 8 will serve as text. 2. Data entry 3. Ensuring patient compliance I. Recruit Patients. Recruit and enroll patients and put in place measures to monitor and ensure patient compliance. See Chapter 9. J. Set up External Review Committees. Their composition is considered in Chapter 4 and their functions in Chapters 4 and 14.
And an experienced full-time employee rides herd over the CRO’s efforts. Financial Times, 10 September 2001 You could use your full-time employees to conduct the clinical trials, or you could hire, on a temporary basis, a few or all of the people you need. You could have a staffing firm supply the programmers you need, and place an advertisement for a consulting statistician. You could even hire a contract research organization (CRO) that will design and conduct part or all of the trials for you.
A regulatory liaison could be one of the above. The regulatory 4 If not, a third physician, preferably one employed by your company, will need to be appointed as medical monitor. 5 See Chapter 15 for a comprehensive description of these duties. 6 See, for example, the section on determining sample size in Chapter 6. 7 See, for example, the bibliography at the end of Chapter 5. 20 PART I PLAN liaison’s formal “role” is to interact with the regulatory agency, assuming (or, more accurately, sharing) the responsibility of interpreting the applicable regulations and ensuring the trials remain in compliance.
A Manager's Guide to the Design and Conduct of Clinical Trials by Phillip I. Good