Grady Memorial Hospital Research Oversight (ROC) Application.doc

2,664 views

Published on

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
2,664
On SlideShare
0
From Embeds
0
Number of Embeds
5
Actions
Shares
0
Downloads
13
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Grady Memorial Hospital Research Oversight (ROC) Application.doc

  1. 1. Grady Health System - ROC APPLICATION (Revised 3-2009) Research Oversight Committee (ROC) Office 404-616-7772 Grady Health System (GHS) Fax 404-616-0747 C/O Cassandra D. Crane, MBA Email: cdcrane@gmh.edu 80 Jesse Hill Jr. Drive SE, P.O. Box 26290 Atlanta, GA 30303 1(Located on 6C- Health Outcomes Center) Guidelines: (see page 3) A. Submission Category: (Please check all that apply). New Protocol: (Study never performed at Grady. Include all documents listed in Section B.) Renewal: (Study has previously been approved by ROC. Include the IRB Renewal Approval letter, the new IRB “Stamped-Approved” Informed Consent and HIPAA Authorization, Lay Summary and any documents that have changed and have been IRB Approved). Modification: (Include the Approved IRB “Request for Modification” form, all the documents that have been revised and “Stamped-Approved” by the IRB and a Lay Summary. Check all that apply: Informed Consent Protocol Personnel Other _______________ B. Documents Required: (Check all documents that are included with this application for submission) ROC Application form (signed by your Grady Chief of Service) GMH Request for Clinical Trial Insurance Plan Code ***New*** (see page 5 of this application) Documentation of Payment Arrangements to GHS (see section I of this application) IRB Approval Letter or IRB Modification Approval Form IRB Submission Form (New, Renewal or Modification) IRB Approved Informed Consent / IRB Approved HIPAA Authorization Lay Summary Data Collection Forms (surveys, questionnaires, telephone scripts, data collection) Research Protocol Advertisements (flyers, brochures, handouts, etc.) C. Study Information: IRB # ______________ IRB Expiration Date: ______________ Obtained IRB Approval From: Emory Morehouse Other:__________________ Title of Study: _______________________________________________________________________ ___________________________________________________________________________________ D. Principal Investigator: (Person noted as Principal Investigator in the IRB approval notice.) PI’s Name (Degree): ____________________________ Emory Morehouse Other:_______ Department & Division _______________________________________________________________ Grady Based Investigator Overseeing Study: _______________________________________________ E. Contact Information: (Person to be notified for any questions, concerns, and approval status). Contact Person: ________________________________________ Phone: ____________________ Email: ____________________Pager #/Cell # ________________Fax: ______________________ 1
  2. 2. ROC APPLICATION F. Locations of Patient Interaction/Enrollment: (i.e. Medical Clinic I, OBGYN, IDP, etc.) _____________________________________________________________________________________ G. Funding: Funded Yes No Pending Sponsor (if applicable) _______________________ H. Services: Will services at GHS be utilized which are not considered part of routine medical care? No Yes Check appropriate box and complete all items on the Grady Memorial Hospital Request for Clinical Trial Insurance Plan Code form (see page 5). Cath Lab Medical Records Non-Invasive Cardiology CT Scan MRI Nursing/Patient Care Services General Radiology Pharmacy Nuclear Medicine Laboratory Ultrasound Other special Services or Equipment: (please specify) _____________________________________ I. Payment of Arrangements: If “Yes” is checked in the above section, an explanation of payment arrangements is required and must be included with this submission packet. See page 4 for the Contact List to make these arrangements with the GHS service that you will utilize. J. Requirements for Consent Form: a. GHS Disclaimer: This statement must be included in the Compensation Section of the consent and should read as follows. “We will give you emergency care if you are injured by this research. However, Grady Health System (you may also include any other institutions that are participating in the study) has not set aside funds to pay for this care or to compensate you if a mishap occurs. If you believe you have been injured by this research, you should contact Dr. _______ (Phone ____)”. b. Patient Rights: This statement must be included in the Contact Persons Section of the consent and should read as follows: “If you are a patient receiving care from the Grady Health System, and you have a question about your rights, you may contact Dr. Curtis Lewis, Senior Vice President for Medical Affairs at (404) 616-4261”. K. Data Collection Form: a. Will a data collection form be used in this study? Yes No b. If so, will this form remain permanently in the patient’s GMH medical record? Yes No **** If you selected “Yes” to this question, the Grady Forms Committee must approve this form. For more information, please contact Director of Health Information Management at 404-616-4277. L. Signatures: The following signatures are required before submitting this packet to the ROC. See Page 3 for the Designated Grady Chief of Services. ________________________________ __________________________ ____________ Signature of Principal Investigator Print Name Date ________________________________ __________________________ ____________ Signature of Grady Chief of Service Print Name Date 2
  3. 3. FYI – The next 2 pages are for informational purposes only and submission is not required with this application. 1 General Guidelines: • Research at GHS: A complete research study must be submitted to the ROC and receive ROC approval before you can begin research, (i.e. patient enrollment or data collection, etc.) in the Grady Health System. • Application: Complete pages 1, 2, and 5 of the ROC Application Form and include only one (1) copy of the documents required. The ROC Application must be completed with each (New, Renewal or Modification) submission. • IRB Approval: You must obtain IRB approval for your study before submitting it to the ROC for approval. • Submission Deadline: All submissions must be submitted by the last Monday of every month in order to be processed for the next committee review, which takes place on the first Monday of every month. Deliver or Mail submission documents to the ROC at the address listed on Page 1 of this application. • Notification of Approval: You will be notified by fax, regarding the status of your study usually within 5-7 business days. • Notification of Payor Code: You will also receive the Payor Code that is assigned to this study from the Grady Patient Financial Services Department. Please use this payor code when registering patients for this particular study/clinical trial. The Designated Grady Chiefs Of Service Permitted To Sign This Application: Department Chief of Service Contact # Anesthesiology Raphael Gershon, M.D. (Chief) 404-616-8760 Dental Services David Reznik, DDS (Chief) 404-616-0414 Dermatology Sareeta Parker, M.D. (Chief) 404-616-7023 Emergency Medicine Leon Haley, Jr., M.D. (Chief) 404-616-6419 Extended Care (Crestview) Vickie James, M.D. (Chief) 404-616-9765 Family Medicine (MSM) Gregory Strayhorn, M.D., Ph.D. (Chief) 404-756-1284 Family, Community & Prev. Medicine Hogai Nassery, M.D. (Chief) 404-616-3570 Gynecology & Obstetrics (EUH) Michael Lindsay, M.D (Chief) 404-616-5416 Gynecology & Obstetrics (MSM) Franklyn Geary, Jr., M.D. (Chief) 404-616-9674 Laboratory Medicine Andrew Young, MD 404-616-4800 Medicine (EUH) Carlos del Rio, M.D. (Chief) 404-616-6779 Medicine (MSM) James Reed, M.D. (Chief) 404-756-1366 Neurology Michael Frankel, M.D. (Chief) 404-616-4013 Neurosurgery (Chief) 404-778-1398 Ophthalmology Geoffrey Broocker, M.D. (Chief) 404-616-5097 Orthopedics George Wright, M.D. (Chief) 404-778-1550 Otolaryngology Charles Moore, M.D. (Chief) 404-616-8261 Pathology George Birdsong, M.D. (Chief) 404-616-4126 Pediatrics (EUH) Robert Geller, M.D. (Chief) 404-616-4403 Pediatrics (MSM) Frances Dunston, M.D., MPH (Chief) 404-756-1330 Psychiatry Steven Levy, M.D. (Chief) 404-616-4807 Radiation Oncology Jerome Landry, M.D. (Chief) 404-778-4731 Radiology Jack Fountain, M.D. (Chief) 404-712-4583 Rehabilitation Medicine Vaddadi Rao, M.D. (Chief) 404-616-7229 Surgery (EUH) David Feliciano, M.D. (Chief) 404-616-5456 Surgery (MSM) Harvey Bumpers (Chief) 404-616-3562 Urology Jeff Carney, M.D. (Chief) 404-778-4954 Hematology/Oncology Mitchell Berger, M.D. 404-489-9185 IDP (Infectious Disease Program) at IDC Jeffrey Lennox, M.D. 404-616-2493 3
  4. 4. Contacts for Research Revised 3/2009 Department Name Office Email Cancer Center, Diagnostic Cardiology Executive Director, Georgia Cancer Center 404-616-4530 Clinical Laboratory Fern Ivy 404-616-4800 fivey@gmh.edu Corporate Compliance Fran Baker (Interim) Corporate Compliance/Ethics, & Privacy Officer 404-616-4268 fbaker@gmh.edu EMCF Research Committee Nadine Kaslow, Ph.D. 404-616-4757 nkaslow@emory.edu Finance (Invoice and Billing Inquiries) Esther Bailes, Director, C/R or Richard Posey, Director, A/R 404-616-0606 404-616-1731 ebailes@gmh.edu rposey@gmh.edu General Clinical Research Center (GCRC) Guillermo Umpierrez, M.D. Program Director 404-778-1665 geumpie@emory.edu Health Information Management (Medical Records and Grady Forms Committee) 404-616-4277 Imaging Services - (Diagnostic Radiology, CT, MRI, Ultrasound, Mammography, Angiography, PET CT, Nuclear Medicine) Joe Price, Administrative Director 404-616-4530 jprice@gmh.edu Information Systems Deborah Cancilla Chief Information Officer 404-616-1735 dcancilla@gmh.edu Laboratory/Clinical Pathology Services Nina Lamson, Administrative Director 404-616-5482 404-616-4800 nlamson@gmh.edu Legal Services Tracy Sprinkle- Dawson Associate General Counsel 404-616-6238 tsprinkle@gmh.edu Neurodiagnostics Laboratories (EEG, EMG) Sarah Killian, Administrative Director, Medical/Surgical Clinics 404-616-4153 404-616-3429 skillian@gmh.edu Nutrition Services Bernardine Joubert, Director 404-616-4301 bjoubert@gmh.edu Patient Care Gaynell Miller, RN Vice President, Patient Care 404-616-3782 gmiller@gmh.edu Patient Care Quality Management and Education Linda Toomer, Director 404-616-5806 ltoomer@gmh.edu Patient Education Felicia Morton, Patient Education Specialist 404-616-5153 fmorton@gmh.edu Pharmacy Philip Powers, PharmD Investigational Drug Coordinator 404-616-3045 404-776-4939 ppowers@gmh.edu Patient Financial Services (Clinical Trial Payor Codes) Maria Kemp Patient Accounts 404-616-7646 mkemp@gmh.edu Rehabilitation Therapy Jackie Reasor, Director 404-616-4081 jreasor@gmh.edu Research Oversight Committee (ROC) Cassandra Crane 404-616-7772 cdcrane@gmh.edu Respiratory Care Services Cynthia Alexander, Chief Therapist 404-616-2270 calexander@gmh.edu 4
  5. 5. Grady Memorial Hospital 5
  6. 6. Request for Clinical Trial Insurance Plan Code Submit completed form along with Grady Research Oversight Committee Application required paperwork. Date: Payor Code: (For use by Grady Patient Financial Services Dept. Only) Institution Receiving Grant: Emory University GSU Other Morehouse CDC IRB#: IRB Expiration: Short Study Title: Type of Study: Funded by Federal Government or other Non-Profit Organization Funded by Industry Emory University FAS Grant Account #: Morehouse Grant Account #: Study Start Date: Projected Study End Date: Research Coordinator Name: Research Coordinator Telephone Number: Research Coordinator Fax Number: Research Coordinator PIC/Pager Number: Research Coordinator E-Mail Address: Principal Investigator Name: Department: Grady Clinic Location: Mailing Address for Invoice: Street Address City State Zip Code Study Related Activities (Lab, Pharmacy, Medical Records, etc.) See list on Page 2 Section H CPT/CDM Description Principal Investigator’s Signature: ______________________________________ Print Last Name: ___________________ For Use by Grady Research Oversight Committee Staff only: ROC Approval Date: ___________ Submit completed form to Grady Patient Financial Services Dept. via fax @ 5-2131 6
  7. 7. Request for Clinical Trial Insurance Plan Code Submit completed form along with Grady Research Oversight Committee Application required paperwork. Date: Payor Code: (For use by Grady Patient Financial Services Dept. Only) Institution Receiving Grant: Emory University GSU Other Morehouse CDC IRB#: IRB Expiration: Short Study Title: Type of Study: Funded by Federal Government or other Non-Profit Organization Funded by Industry Emory University FAS Grant Account #: Morehouse Grant Account #: Study Start Date: Projected Study End Date: Research Coordinator Name: Research Coordinator Telephone Number: Research Coordinator Fax Number: Research Coordinator PIC/Pager Number: Research Coordinator E-Mail Address: Principal Investigator Name: Department: Grady Clinic Location: Mailing Address for Invoice: Street Address City State Zip Code Study Related Activities (Lab, Pharmacy, Medical Records, etc.) See list on Page 2 Section H CPT/CDM Description Principal Investigator’s Signature: ______________________________________ Print Last Name: ___________________ For Use by Grady Research Oversight Committee Staff only: ROC Approval Date: ___________ Submit completed form to Grady Patient Financial Services Dept. via fax @ 5-2131 6

×