Office for Clinical Research (OCR) Study Submission Form

Office for Clinical Research (OCR) Study Submission Form

If EPEX Submission is not required for your study, email all documents as a package to:

Principal Investigator and Department Information
Name: / Office Phone #: / Cell Phone #:
School: / Dept: / Division: / PIC #:
Email: / PI Emory Faculty?: Y N
Sub-PI and Department Information (Only if effort attached to study- If more than two, submit separately or note at the bottom of page 2)
Sub-PI #1 - Name: / Office Phone #: / Cell Phone #:
School: / Dept: / Division: / PIC #:
Email: / Sub-PI Emory Faculty?: Y N
Sub-PI #2 Name: / Office Phone #: / Cell Phone #:
School: / Dept: / Division: / PIC #:
Email: / Sub-PI Emory Faculty?: Y N
Is PI or Sub-PI an Emory Specialty Associate (ESA) Physician?: Y N NA
If yes, where conducting research?: Saint Joseph’s John’s Creek List if Other Facility:
Clinical Research CoordinatorInformation
Name: / Office Phone #: / Cell Phone #:
Email:
Department/Research Administrator (DA/RA) or RAS Information
Name: / Office Phone #:
Email:
Additional Contacts (Specify the names and email addresses of others not listed above who need to be copied on emails or sent the PRA and/or budget)
Name: / Name:
Email: / Email:
Study Information / Length of Study: Months or Years
Protocol Title:
Short Title/Acronym: / Protocol Version and Date:
IRB#: / EPEX #:
Competitive Enrollment?: Y N / Target Enrollment #:
Is this an Amendment?: Y N / Are you expecting any amendments in the next 30 days? Y N
CRN/ACTSI? Y N / Overnight Stay CRN? Y N / CRN/ACTSI Application Approved? Y N Pending or NA
PI Initiated?: Y N / Other (Specify):
Registered withClinicalTrials.gov?: Y N Unknown / ClinicalTrials.gov (NCT)#:
Drug or Device Information(Check all that apply)
Drug Study?: Y N NA IND#: / IND Exempt?: Y N NA / IND Holder:
Device Study?: Y N NA IDE#: / IDE Exempt: (FDA approved, 510K, PMA, HDE, or Abbrev IDE):
IDE Holder:
Emory Purchasing Notified? Y N NA (see form on / Contacted EHC Office Of Compliance for submission to Local Medicare Director?
Y N NA (contact for info)
Ifnot provided free, is price approved by Emory Healthcare?: Y N NA
If Drug Trial – Phase: I II I/II III IV / If Device Study - Category: A B NA
Name of Drug/Device (If more than 5, list on bottom of next page) / Provided Free by Sponsor? / FDA Approved? / Approved for this Indication?
Y N / Y N / Y N
Y N / Y N / Y N
Y N / Y N / Y N
Y N / Y N / Y N
Y N / Y N / Y N
Funding Sources (Check all the apply)
Federal / Federal Flow Through / Umbrella Grant / Foundation (Specify): / Sub-Contract
Industry / Internal, Department / Other (Specify):
-Has the budget been pre-negotiated?: Y N NA
-Received the Notice of Award?: Y N NA
Sponsor Information / Sponsor Name:
Budget Contact: / Contract Contact:
Email: / Email:
Phone #: / Phone #:
Contract Research Organization (CRO) / Y N NA / CRO Name:
Budget Contact: / Contract Contact:
Email: / Email:
Phone #: / Phone #:
Check all Facilities where Subjects will be seen
Children’s Egleston: Hughes Spalding or Scottish Rite
Emory Children’s Center (ECC)
Emory Clinic (TEC)
Emory University Hospital (EUH)
Emory University Hospital Midtown (EUHM)
Emory Orthopedic & Spine Hospital
Other (Specify): / Emory Vaccine Center (Hope Clinic)
Grady Memorial Hospital
Grady-Ponce Center
John’s Creek Hospital
Saint Joseph’s Hospital
Wesley Woods Hospital/Health Center
Will you Use any of these Facilities?(If checked note fee or room charge) / Fee or Room Charge:
ACTSI/CRN
BITC / Ambulatory Surgical Center (ASC)
Pediatric Research Center / Hospital OR
Infusion Center / CSI/WW
Sibley Heart Center / Dedicated Research Space
Required Documents
Completed Study Submission Form
Emory Draft Consent Form
Sponsor Budget / Final Protocol (No drafts will be accepted)
Clinical Trial Agreement or Award Letter
PI Effort Sheet(s) (Only needed if negotiable budget)
Other Documents (If available/applicable)
Y N Draft Budget Prepared by Department
Y N ACTSI/CRN Budget/Application
Y N Additional Fees for Radiology Services / Y N IND/IDE Approval Letter
Y N IND/IDE Exemption Letter
Y N Emory/PI Standard Practice Protocols/Guidelines
Study Items/Services – Regardless if SOC/Routine Care / If Yes, check all that apply and provide information
Physical Exam/Office Visit
Y N / Research Room - no EHC billable
Y N / CPT code used No CPT code used (Effort only)
Electrocardiogram (ECG) / Y N / ECG machine provided by sponsor
Study Staff will perform Study staff will read / Tracing to Central Lab
Cardiology will perform Cardiology will read
Pregnancy Test / Y N / Test sent to Emory Lab
Test sent to Central Lab
POC (Point of Care Testing) / Kits provided by sponsor Kits bought by department
Radiology/Imaging / Y N / BITC CSI/WW Emory Radiology Sibley Heart Center
Grady CHOA Other (Specify):
Lab Samples / Y N / Emory Medical Lab (EML) Emory Pathology Lab
Central Lab Internal Emory Research Lab / Other (Specify): POC (Specify):
Additional lab preparatory fees, provide cost:
Anesthesia/Sedation / Y N / General Anesthesia
Conscious/MAC Sedation
Local / Time required:
Patient Compensation/Stipends? / Y N / Amount(s):
Comments and/or Items/Services Not Addressed Above

This form is an important step as we continue to improve our processes. Forany questions about this form, email . Thank you for your support.

Version: 2.0 Form Revision Date: 03/04/2014

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