
Purpose
for conducting study.

State
whether human use is considered routine or non-routine. Include
the research protocol for non-routine use.

Give
the plan of investigation in sufficient detail to permit a critical
evaluation of the radioisotope methodology to be employed and
the radiation safety controls to be established.

Description
of human subjects. Include their statement of consent.

Quantity
of radioactive material to be administered (in millicuries).

Calculation
of radiation dose.

Statement
on the adequacy of the physical facilities and equipment for supporting
the proposed study.

Qualification
of the individuals responsible for the study.

Estimated
time needed for completion of the study.

Schedule
for reporting the results of the study.