Duke Raleigh Hospital

Duke Raleigh Hospital

New Study submission FORM

Check here if you are a non-Duke community physician submitting a study for review at DRaH: / If you are submitting an Oncology study for review at DRAH, please contact the Duke Oncology Network at (919) 419-4631 before filling out this submission form.
Date: / Duke IRB #:
Study: / Short Name: / Full Name:

section 1: Study and billing information

Clinical Research Coordinator (CRC): / Phone.:
Street address: / Fax.:
City/State: / Zip: / Email: / DRAH contact:
Duke PI: / Phone: / Email:
Any questions about the study? Contact phone: pager: fax: email:
Extra Costs to Subjects / Yes / No / Investigational: / Yes / No
visits / drugs
hospital / device
drugs / Confidential:
tests / questionnaires
other: / records
Utilization of DRaH Personnel/Resources / photo(s)
nursing personnel / other:
pharmacy / Risks:
lab / psychological
radiology / physical
medical records / Subject Compensation:
resource distribution (IV pumps, etc) / How much?
operating room / Will patients be: inpatient outpatient both
other: / Anticipated duration of study:
Study involves: research data collection only drug(s) device therapy/treatment
Drug(s): ; IND #: ; commercially available supplied by study administered as off-label
Device: Name: ; IDE #: ; CMS Class Device: A B; purchased supplied by sponsor
Grant # / Fund code: / Is this an NIH trial? Yes No
List anticipated services which are NOT standard of care (non-routine):
Non-Routine Services to be billed to: Name Address Phone / Discount Price: Yes No; If Yes, % of Discount:
Will DRH be paid by sponsor for certain milestones reached or data gathering? Yes No
Invoice should be mailed to: Name Address Phone

section2: drah personnel and resources

Resource / Responsibility (please list N/A if no resources needed) / Estimated Hours and Cost
Nursing
Pharmacy
Lab
Radiology
Medical Records
Operating Room
Investigational Drug(s) / Who is responsible for receipt, preparation, dispensing and administration?
Investigational Device / Who is responsible for receipt, preparation, dispensing and administration?
Financial / Total estimated cost to DRAH
Have any funds been allocated to this study? Yes No / Total compensation to DRAH:
One Copy of the following documents must be submitted along with the New Study Submission Form if you are sending hardcopies. You may submit this information electronically to the following:
Tracy Killette 919-862-5965 ()
1. Study protocol
2.  Consent Form for use at Duke Raleigh Hospital
3.  Documentation of DUHS IRB Approval
4. Statement of Financial Disclosure by Investigator, if applicable
5. FDA Approval Letter (Contains CMS Category), if applicable
6. Budget/Activity grid, if applicable
7. Documentation of CRC Training for Study CRC and DRAH CRC contact person
8. Contracts
Should you have questions regarding this form or approval process, please call Tracy Killette (Duke Raleigh) at telephone number 919 954-3106.
Should you have questions involving clinical issues or operational processes at Duke Raleigh Hospital, please call:
Medical Staff Affairs: Tracy Killette 862-5965
Pharmacy: Gene Woodall 954-3572
Laboratory: Peter Eschenfelder 954-3117
Radiology: Nancy Davis 954-3627
Nursing: Priscilla Ramseur 954-3291
Surgical Services: Juanita Currin 954-3483
Medical Records: Tammy Crane 954-3562
Finance: Leigh Bleecker 954-3516
Donna Hannon 862-5836
Risk Management: Anita Klinek 954-3123
Administration: Dr. Michael Spiritos 954-3343
Special Diagnostics Mathew Holder 954-3667
Cancer Center Jennifer Garst 954-3376
Page 1 of 1 / form version 04-18-13