Attachment III - Page 1 
BUREAU OF DRUGS 
GUIDE 
BD 4831.1 ATTACHMENT A 
IND MEDICAL REVIEW GUIDELINES 
IND # 
M.O. Review # 
Sponsor 
Date Review Completed 
1. Resume 
This should be a one page sunmary of the proposed study analogous to 
the abstract of a scientific paper. The summary should be introduced 
by a sentence or two classifying the drug, its intended use, its 
potential clinical advantages, and the general objective of the 
study. The indication or disease under the study, the type and 
number of patients, the principle clinical end points being utilized, 
the type of controls and other important characteristics of the study 
should be included as space and their importance permits. If the 
design is complete, a flow chart or schema of alternative paths of 
treatment should be considered for this summary presentation. 
This one page abstract should be suitable to stand alone as a summary 
of the proposed study and should be on a page by itself appropriately 
identified with provisions for the sponsor's name, date of submission 
and IND number. 
An illustration example (places to be filled in are underlined) 
follows. 
This IND proposes to study the use of ( generic/trade ) , a ( drug 
category ) , in ( symptom , disease , etc.). One (the) submitted protocol 
is for an ( n-month ), ( controlled , double-blind , single-blind , etc.) 
study in ( # patients ) with [ patient characteristics ) to Cspecif ic 
objective of the study ). The principal investigator ( appears/does 
not appear to be ) qualified. ( Brief statement about rationale for 
study; where it fits in overall investigation, why it is being done, 
if not obvious ). ~ 
The pre-cl ini cal data suggest that 
are particular points of concern and also suggests ( important - 
conclusions other than adverse-reaction related ones ). Previous 
study/studies with similar drugs in humans have/have not been carried 
out and ( results regarding safety, appropriate dose, etc., as 
important ) . 
The proposed study ( brief summary and evaluation of experimental 
procedures emphasizing clinical end-pcints, measures to avoid 
Resume 
CT MO. 
BD 80-23 (8/14/30) 
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