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By Frank L. Iber M.D., W. Anthony Riley M.D., Patricia J. Murray B.A. (auth.)

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Re: Anna Banana, Birthdate June 15, 1942 Dear Dr. Emory: I appreciate the sincerity of your call regarding Anna Banana, who is currently enrolled in our study (placebo-controlled) of a novel molecule in thE! y fever. Ms. na answered our advertisement in the newspaper, was thoroughly examined, and qualified for this study, starting on April 1, 1985, in time for the full allergy season. k1ng and I have enclosed a copy of the informed consent. The initial laboratory tests on Ms. na are also enclosed for your subsequent management of her condition.

Reich, ed. in chief), Macmillan and Free Press, New York, 1978. M. , New York, 1985. CHAPTER 5 Budget Planning and Development Planning the Budget • Evaluating the Protocol • Recruitment • Payments or Reimbursements to Subjects • Converting Plans into Cost Estimates • Administrative Support and Paper Work • Personnel • Overhead • Contingency Funding • Cost Cutting and Savings • Money Management • Submission and Negotiation of the Budget • Final Contracting A budget is awarded as a part of each contract to conduct drug or device research and to a large degree determines what can be accomplished as a part of the investigation.

In Need of Referral During a 16-week study of an antiarthritic drug, the investigators met regularly with the 20 subjects and provided them with a great deal of counsel about their general health, immunizations, intercurrent illnesses unrelated to the drug, and their disease. One subject completed the study and continued to call for these services. Initially they were delivered, but with a great deal of frustration that evolved into hostility. The investigator did not fully appreciate, however, that while he had been an enthusiastic general health provider while the patient was in the study, his attitude had subsequently shifted to one of lack of interest after the study was completed.

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