Data Safety Monitoring
Principal Investigator Service Request Form

The Georgia Clinical & Translational Science Alliance (Georgia CTSA) now offers resources that support the investigator with the development of a Data Safety Monitoring Plan and/or Board (DSMP/DSMB).

Please submit the questionnaire below. You will receive a confirmation email of receipt within three business days. Your service determination will be completed within 7-14 business days and a Studio Consultation will be scheduled if applicable.

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1. Date: (Required.)

MM/DD/YYYY

Date

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2. Contact Information:

Name

Title (MD, PhD, RN, PA-C, etc.)

Email Address

Phone Number

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3. Preferred Contact:

Phone

No Preference

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4. Best Time to Discuss Request

Morning (8am - 11am)

Afternoon (12pm-3pm)

Evening (After 4pm)

No Preference

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5. School (School of Medicine, Rollins School of Public Health, etc.)

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6. Department (Emergency Medicine, Neurology, Medical Oncology, etc.)

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7. Support Requested (Check all that apply)

Data Safety Monitoring Board (DSMB) Registry of participating members

Data Safety Monitoring Plan (DSMP) Charter Template

NIH Guided DSMB Charter Template

Information regarding available resources

Biostatistics, Epidemiology, Research, and Design (BERD)

Office of Compliance (OC)

Full Studio Consultation (Clinical Trials Audit and Compliance (CTAC), Regulatory Knowledge and Support (RKS), and Clinical Research Navigator (CRN)

Other (please specify)

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8. Protocol Title

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9. Is this a Clinical Trial?

Yes

No, Skip to Question #12

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10. If #9 is Yes, indicate the type of clinical trial below:

Interventional

Observational, Skip to Question #12

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11. Indicate Phase of the Clinical Trial:

Phase I: Testing of an experimental drug or treatment in a small group of people for the first time. The clinical trial evaluates the treatment's safety, efficacy, safe dosage, and identify side effects.

Phase II: The experimental drug or treatment is given to a large group of participants to determine effectiveness, and further evaluate its safety.

Phase III: The experimental drug or treatment is given to a large group to confirm its effectiveness, monitor side effects, data collection to evaluate experimental drug or treatment safe usage, and/or compare commonly used treatments.

Phase IV: Treatment currently approved by the FDA for use. Data collection to indicate the drug's risks, benefits, and best use.

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12. Who holds the Investigational New Drug (IND) or Investigational Device Exemption (IDE)?

Emory Investigator/Sponsor Investigator

University of Georgia (UGA) Investigator/Sponsor Investigator

Morehouse School of Medicine (MSM) Investigator/Sponsor Investigator

Georgia Institute of Technology (Georgia Tech) Investigator/Sponsor Investigator

Sponsor

Other (please specify)

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13. Indicate all locations where study will be conducted: (Check all that apply) (Required.)

The Emory Clinic (Building A, B, or C)

Winship Cancer Institute (WCI)

Emory University Hospital-Main Campus (EUH)

Emory University Hospital-Midtown (EUHM)

Emory University Decatur Hospital

Emory Johns Creek Hospital (EJCH)

Emory Orthopaedic & Spine Hospital (EUOSH)

Emory Wesley Woods Hospital (EWWH)

Emory Children's Center (ECC), Scottish Rite PRC, or CHOA PRC

Atlanta VA Medical Center

Grady Healthcare

Morehouse School of Medicine (MSM)

University of Georgia (UGA)

Georgia Institute of Technology (Georgia Tech)

Other (Specify Location for MSM, UGA, and Georgia Tech Studies)

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14. Has protocol been submitted to the IRB?

Yes

Date (submitted or anticipated)

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15. Is this a multi-site study in which you are the lead Principal Investigator?

Yes

No, Skip to Question #17

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16. If #15 is Yes, list the names of other participating sites:

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17. Data Safety Monitoring Plan (DSMP):
See Appendix
C -Emory IRB Guidance

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18. Data Safety Monitoring Board (DSMB) Charter
See Appendices
E- NIH Data and Safety Monitoring Board (DSMB) Charter
F- Data and Safety Monitoring Board (DSMB) Charter Outline

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* 1. Date: (Required.)

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* 2. Contact Information:

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* 3. Preferred Contact:

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* 4. Best Time to Discuss Request

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* 5. School (School of Medicine, Rollins School of Public Health, etc.)

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* 6. Department (Emergency Medicine, Neurology, Medical Oncology, etc.)

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* 7. Support Requested (Check all that apply)

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* 8. Protocol Title

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* 9. Is this a Clinical Trial?

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* 10. If #9 is Yes, indicate the type of clinical trial below:

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* 11. Indicate Phase of the Clinical Trial:

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* 12. Who holds the Investigational New Drug (IND) or Investigational Device Exemption (IDE)?

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* 13. Indicate all locations where study will be conducted: (Check all that apply) (Required.)

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* 14. Has protocol been submitted to the IRB?

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* 15. Is this a multi-site study in which you are the lead Principal Investigator?

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* 16. If #15 is Yes, list the names of other participating sites:

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* 17. Data Safety Monitoring Plan (DSMP): See Appendix C -Emory IRB Guidance

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* 18. Data Safety Monitoring Board (DSMB) CharterSee AppendicesE- NIH Data and Safety Monitoring Board (DSMB) CharterF- Data and Safety Monitoring Board (DSMB) Charter Outline

Question Title

1. Date: (Required.)

2. Contact Information:

3. Preferred Contact:

4. Best Time to Discuss Request

5. School (School of Medicine, Rollins School of Public Health, etc.)

6. Department (Emergency Medicine, Neurology, Medical Oncology, etc.)

7. Support Requested (Check all that apply)

8. Protocol Title

9. Is this a Clinical Trial?

10. If #9 is Yes, indicate the type of clinical trial below:

11. Indicate Phase of the Clinical Trial:

12. Who holds the Investigational New Drug (IND) or Investigational Device Exemption (IDE)?

13. Indicate all locations where study will be conducted: (Check all that apply) (Required.)

14. Has protocol been submitted to the IRB?

15. Is this a multi-site study in which you are the lead Principal Investigator?

16. If #15 is Yes, list the names of other participating sites:

17. Data Safety Monitoring Plan (DSMP):
See Appendix
C -Emory IRB Guidance

18. Data Safety Monitoring Board (DSMB) Charter
See Appendices
E- NIH Data and Safety Monitoring Board (DSMB) Charter
F- Data and Safety Monitoring Board (DSMB) Charter Outline