Research Oversight Committee - Application for Study Consideration

Research Oversight Committee - Application for Study Consideration
Please type information and identify all abbreviations used. All questions must be answered. Incomplete forms will not be accepted. Please type 'N/A' if a question does not apply.
Name of Person Submitting Request*

First NameLast Name
Name and Qualifications of Principal Investigator*
Name and Qualifications of Co-Investigators*
Please attach any supporting documents below, including:
- IRB Letter
- Citi Training Certificate
- NIH/GCP Certificate
- HIPAA Authorization
- CV (if not currently a member of any DCH medical staff or DCH employee)
- Anything else that would help support the request
Must be PDF, DOC, DOCX, RTF, or ODT
Cancelof
Name of Sponsoring Company/Organization*
Name of Sponsoring Company/Organization [Other]*
Enter sponsoring company or organization.
Address of Sponsoring Organization*

Street Address

Street Address Line 2

CityState / Province

Postal / Zip Code
Number of Anticipated Subjects*
Patient Types*

InpatientOutpatient
Locations*

Regional Medical CenterNorthport Medical CenterFayette Medical Center
Begin Date*

MonthDayYear
Date
Projected Ending Date*

MonthDayYear
Date
Purpose/Summary, including Risks and Benefits:*
How will patients be identified for participation in the study?*
Describe how patients in this study will be monitored on an ongoing basis.*
Any special inspection/approval needed by Professional Activity Committee, Pharmacy, Pathology, Radiation Safety, Biomedical Engineering Department, Information Services, Health Information Management, etc., according to hospital policy (e.g., drug storage, specimen handling, radiation, electrical devices, medical record access):*

Yes (consultation with ROC Coordinator completed)No
Location of Study (patient care area, physician office, etc.)*
Name(s) and contact information of those responsible for supervision:*
Describe procedure for maintaining confidentiality in accordance with HIPAA:*
How will data/information be used and who will have access (data consultation completed): *
Will the study involve the participation of any of the following vulnerable populations? (check all that apply):*

No vulnerable populations will be enrolledPregnant WomenFetusesMinorsPrisonersMentally Disabled

Cost of Drug/Device*

	Cost
To Investigator
To Hospital
To Patient

Other Costs Involved:*
How Project Is To Be Funded
From Whom*
Amount*
Who Received*
Are Federal Funds Being Used?*

YesNo
Please Provide Grant Number
Is this study a protocol involving research conducted or supported by the Department of Health & Human Services (HHS)?*

YesNo
Which agency(ies)?
Is this study a protocol involving research regulated by the U.S. Food & Drug Administration (FDA)?*

YesNo
Describe the types of FDA-regulated products (such as biological products, color additives, food additives, human drugs, or medical devices):
Disclosure of financial payments to patients:*
Disclosure of financial interest(s) to investigator, their practice, or their family derived from this project:*

NoneUnder $2,000$2,000-$5,000Over $5,000
Has this material been reviewed by an external IRB (required for submission)?*

YesNo
Name/Location of additional IRB Review:
What is the name of the external IRB to which you will be submitting for review?*

WIRB - Copernicus GroupUniversity of Alabama IRBMD Anderson IRBNCI Central IRBOther
Signature, Person Submitting Request*

Clear
Signature, Principal Investigator*

Clear
I attest that I have received approval from the principal investigator*

Check Here
Date*

MonthDayYear
Date
Phone Number*
Please enter a valid phone number.
Mailing Address*

Street Address

Street Address Line 2

CityState / Province

Postal / Zip Code
Email Address*
example@example.com
Contact Information for questions related to completion of this form:

ROC Email: research@dchsystem.com

Mary Leach
Research Oversight Committee Coordinator
(205) 759-7919
ROC Email
example@example.com
Copy Email
example@example.com
Should be Empty:

Research Oversight Committee - Application for Study Consideration

How Project Is To Be Funded