2a. The investigator assures that an IKB that complies with 
the requirements set forth in Part 56 of this chapter will be 
responsible for the initial and continuing review and approval 
of the proposed clinical study. The investigator also assures 
that he/she will report to the IRB all changes in the research 
activity and all unanticipated problems involving risks to 
human subjects or others, and that he/she will not make any 
changes in the research that would increase the risks to human 
subjects without IKB approval. FDA will regard the signing 
of the Form FDA 1573 as providing the necessary assurances 
stated above. 
b. A description of any clinical laboratory facilities that will 
be used. (If this information has been submitted to the spon- 
sor and reported by him on Form FDA 1571, reference to the 
previous submission will be adequate). 
3. The investigational drug will be used by the undersigned 
or under his supervision in accordance with the plan of Investi- 
gation described as follows: (Outline the plan of investigation 
including approximation of the number of subjects to be 
treated with the drug and the number to be employed as con- 
trols, if any: clinical uses to be investigated; characteristics of 
subjects by age, sex and condition; the kind of clinical obser- 
vations and laboratory tests to be undertaken prior to, during, 
and after administration of the drug; the estimated duration 
of the investigation; and a description or copies of report 
forms to be used to maintain an adequate record of the obser- 
vations and test results obtained. This plan may include rea- 
sonable alternates and variations and should be supplemented 
or amended when any significant change in direction or scope 
of the investigation is undertaken.) 
4. THE UNDERSIGNED UNDERSTANDS THAT THE FOL- 
LOWING CONDITIONS, GENERALLY APPLICABLE TO 
NEW DRUGS FOR INVESTIGATIONAL USE, GOVERN 
HIS RECEIPTS AND USE OF THIS INVESTIGATIONAL 
DRUG: 
a. The sponsor is required to supply the investigator with full 
information concerning the preclinical investigations that 
justify clinical trials, together with fully informative material 
describing any prior investigations and experience and any 
possible hazards, contraindications, side-effects, and precau- 
tions to be taken into account in the course of the investiga- 
tion. 
b. The investigator is required to maintain adequate records 
of the disposition of all receipts of the drug, including dates, 
quantities, and use by subjects, and if the investigation is 
terminated, suspended, discontinued, or completed, to return 
to the sponsor any unused supply of the drug. If the investi- 
gational drug is subject to the Comprehensive Drug Abuse 
Prevention and Control Act of 1970, adequate precautions 
must be taken including storage of the investigational drug 
in a securely locked, substantially constructed cabinet, or 
other securely locked substantially constructed enclosure, 
access to which is limited, to prevent theft or diversion of the 
substance into illegal channels of distribution. 
Attachment TV - Page 2 
c. The investigator is required to prepare and maintain ade- 
quate and accurate case histories designed to record all obser- 
vations and other data pertinent to the investigation on each 
individual treated with the drug or employed as a control in 
the investigation. 
d. The investigator is required to furnish his reports to the 
sponsor of the drug who is responsible for collecting and eval- 
uating the results obtained by various investigators. The spon- 
sor is required to present progress reports to the Food and 
Drug Administration at appropriate intervals not exceeding 
I year. Any adverse effect that may reasonably be regarded 
as caused by, or probably caused by, the new drug shall be 
reported to the sponsor promptly, and if the adverse effect 
is alarming, it shall be reported immediately. An adequate 
report of the investigation should be furnished to the sponsor 
shortly after completion of the investigation. 
e. The investigator shall maintain the records of disposition 
of the drug and the case histories described above for a period 
of 2 years following the date a new-drug application is ap- 
proved for the drug; or if the application is not approved, 
until 2 years after the investigation is discontinued. Upon the 
request of a scientifically trained and properly authorized 
employee of the Department, at reasonable times, the investi- 
gator will make such records available for inspection and 
copying. The subjects’ names need not be divulged unless the 
records of particular individuals require a more detailed study 
of the cases, or unless there is reason to believe that the rec- 
ords do not represent actual cases studied, or do not represent 
actual results obtained. 
f. The investigator certifies that the drug will be administered 
only to subjects under his personal supervision or under the 
supervision of the following investigators responsible to him, 
and that the drug will not be supplied to any other investi- 
gator or to any clinic for administration to subjects. 
g. The investigator certifies that he will inform any subjects 
including subjects used as controls, or their representatives, 
that drugs are being used for investigational purposes, and 
will obtain the consent of the subjects, or their representatives, 
except where this is not feasible or, in the investigator’s pro- 
fessional judgment, is contrary to the best interests of the 
subjects. 
h. The investigator is required to assure the sponsor that for 
investigations subject to an institutional review requirement 
under Part 56 of this chapter the studies will not be Initiated 
until the institutional review board has reviewed and approved 
the study. (The organization and procedure requirements for 
such a board as set forth in Part 56 should be explained to 
the investigator by the sponsor.) 
Very truly yours, 
Name of Investigator 
Address Telephone ( ) 
(This form should be supplemen ted or amended from rime to rime If new subjects are added or If sign! pc an t changes are mode In the plan of Investigation. J 
a u.8.apo-.t9®a-o-464-aaa/ia77« 
[590] 
