DREXEL UNIVERSITY INTERNAL AUTHORIZATION
FORM FOR WESTERN IRB REVIEW
1.
Project Title
2.
Principal Investigator
(PI)
Academic Title:
Phone
4.
No:
E-Mail:
Fax No:
Address:
Dept:
Are you (PI) certified to conduct research involving human subjects?
Yes [ ]
No [ ]
Date of Certification: ________________
Are your co-investigators or key personnel in this project certified
Type Name of Co-Investigator or Key
Date of Certification
to conduct research involving human subjects?
Personnel
Co-Investigator [ ] Key Personnel [ ]
Co-Investigator [ ] Key Personnel [ ]
__________________________________ _________________
Co-Investigator [ ] Key Personnel [ ]
__________________________________ _________________
Co-Investigator [ ] Key Personnel [ ]
__________________________________ _________________
Co-Investigator [ ] Key Personnel [ ]
__________________________________ _________________
Co-Investigator [ ] Key Personnel [ ]
__________________________________ _________________
(Add more names, if necessary)
__________________________________ _________________
(Note: Federal regulation mandates that effective October 1, 2000
all investigators and key personnel must be trained and certified to
(If not certified, Type
conduct research involving human research subjects.)
NO)
Do you plan to advertise for volunteers in any way? (If yes, attach
Yes
No
copy/copies of advertisement with submission.)
What is your proposed method of advertisement?
Bulletin boards
Electronic media
CHECK ALL THAT APPLY.
Print ads
Radio/TV
Other
(DESCRIBE) __________________________
3.
4.
5.
6.
7.
PROPOSED CLINICAL TRALS INVOLVES THE FOLLOWING
8.
9.
10.
11.
Investigational drugs or new use of marketed drugs
Yes
No
IND Number:
Issued by:
Generic Name:
_______________________
________________________
_____________________________
Investigational Devices. Indicate NSR ….. ; or SR.
NSR
SR
IDE # If SR:…………..
If SR, provide IDE #
If you answered yes to questions 6 and 7, and if the study involves an external sponsor, have you
Yes
contacted the Office of Research Contract Division regarding this clinical trial?
No
RADIATION EXPOSURE
12.
Includes Radioactive drugs/ unusual exposure to radiation
13.
Requires Biosafety review?
Yes
No
Procedure Type
________________
________________
BIOSAFETY
Yes
No
Signature
Date
Principal Investigator (Type Name)
Co-Investigators (Type Names)
1.
2.
3.
4.
5.
6.
7.
Department Chair (Type Name)
HRP APPROVAL
Approved for submission to WIRB
Drexel Med Contact Person:
Not Approved for Submission. Reason:
Human Research Protection
1
02-07-2013