Standard Operating Procedures (SOP)

I. Regulatory Affairs
A. IRB submission
B. VA submission
C. Informed consent
D. IRB approval
E. Clinical regulatory documents
F. Amendments
G. Completing FDA Form 1572
H. IND submission-Initial submission-Sponsor or investigator
I. IND submission-Investigator Initiated
J. Completing FDA Form 1571
K. Reporting SAE's from other sites

II. Conducting Clinical Trials
A. Role of the study coordinator
B. Subject recruitment
C. Advertising
D. Obtaining informed consent
E. Maintaining patient confidentiality
F. Recording Data in CRF's
G. Obtaining medical history
H. Obtaining vital signs
I. Obtaining ECG
J. Obtaining urine samples
K. Blood Draws
L. Conducting rating scales
M. Randomization of patients and maintaining the blind
N. Storage, distribution and administration of drug
O. Premature discontinuation of subject
P. Premature discontinuation of study
Q. Breaking the study blind
R. Reporting AE's that occur at UC or VA
S. Maintaining regulatory documents binder

III. Study Quality Assurance
A. Patient tracking and reporting