Attachment III - Page 6 
BUREAU OF DRUGS 
■■ — 
GUIDE 
BD 4831.1 
ATTACHMENT A 
(5) Results of statistical consultation. If none was obtained, 
indicate at what point in the overall investigation a 
statistical consultation would be most appropriate. 
7. Summary Statements Regarding the Adequacy of the Protocol 
All six should be included. Any may be elaborated on as indicated. 
a. The risks of the proposed study (are/are not) acceptable in view 
of its objectives. 
b. The risks (are/are not) adequately appreciated. 
c. Adequate precautions (are/are not) being taken. 
d. Patients (are/are not) adequately informed through the informed 
consent form. (Note that the regulations do not require the 
investigator or sponsor to submit an informed consent form. If 
the reviewing division had a particular concern about a drug for 
safety reasons, then a copy of the consent form should be 
requested). 
e. The study objectives (are/are not) clear and (are/are not) based 
on a sound rationale. 
f. The stu'dy protocol (is/is not) adequate to provide data that 
will achieve the study objectives. 
8. Recommended Regulatory Action . One of the following should be 
included.' Any may be elaborated on if the M.O. so desires. In those 
cases in which other than a standard regulatory action is recommended 
the rationale should be presented: 
a. Study may proceed without modification. 
b. Study may proceed but would suggest considering the 
modifications suggested in the deficiency list. 
c. Study may proceed if deficiencies , , 
, . . * are corrected. 
d. Study may not proceed until the action taken to correct 
deficiencies , , , .... are 
reviewed by the Agency. 
e. Study may not proceed because repeated attempts to demonstrate a 
scienfitic rationale (or pharmacologic effect) have not 
succeeded. 
G ™°* BD 80-23 (8/14/80) ^ 6 
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