Attachment III - Page 4 
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BUREAU OF DRUGS 
6. Proposed Clinical Studies 
GUIDE 
BD 4831.1 
attachmenta 
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a. 
Clinical monitor(s) and clinical investigator(s) - Include name, 
title, business address and identify specifically where the 
proposed study is to be conducted. 
(1) Is the monitor qualified? 
(2) Is the investigator qualified? 
b. Objective of the study - This should be stated as explicitly and 
precisely as possible, e.g. "dose-finding study" is not optimal, 
rather "to find the minimum dose that will produce a (specified) 
improvement in patients with . " Other examples 
would include: "To compare the efficacy ("even better, specify 
the measurement of efficacy to be used) of (a particular dose 
of ) with placebo (or another drug, or 
another dose) in patients with . " 
c. Rationale for study - where it fits into overall investigation, 
why necessary and reasoning behind the proposed use of the drug 
(if not apparent). 
d. Experimental Design 
(1) Patient Population 
(a) Demography 
i number, 
ii age, 
iii sex, 
iv source; 
(b) Clinical characteristics for inclusion such as: 
i. history, 
ii symptoms, 
iii physical, 
iv lab findings (and comment on adequacy); 
(c) Exclusion, including: 
i concurrent diseases not permitted; 
ii concurrent medications not permitted (and how 
concurrent medications will be identified in 
patient's records); 
iii others. 
OTMO * BD 80-23 (8/14/80) pa6£ 4 
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