Working with The Johns Hopkins University General Clinical Research Center (GCRC)

1. Working withThe Johns Hopkins UniversityGeneral Clinical Research Center(GCRC) http://www.hopkinsmedicine.org/gcrc/

2. Who We Are • Funded by a competing grant (M01-RR0052) from the NIH/NCRR • Serve as a centralized clinical research resource to all Hopkins faculty • Support investigator-initiated, federally funded clinical research projects • Support non-funded pilot studies, feasibility trials, and industry-sponsored research

3. What We Provide • Initial constructive, detailed, scientific review of research protocols, consent and assent form(s), GCRC application, human subjects section, etc. • Ongoing review of amendments to the protocol, annual IRB renewal documents, protocol event reports (violations, deviations, adverse events, IND Safety Reports)

4. We Also Provide • Computer and Data Management Support • Biostatistical Support • Nutrition Services • Training and Education • Ancillary Services • Research Subject Advocate Program

5. Where We Provide Services • PCRU – Pediatric Inpatient and Outpatient Unit, Blalock 3 • OPD – Adult Outpatient Unit, Carnegie 3 • Adult Inpatient Unit, Osler 5 • NBRU – Neurobehavioral Research Unit, Kennedy-Krieger Institute • SKCCC – Weinberg Cancer Center • Administrative Offices, Carnegie 446

6. What We Require Initially • a GCRC application including human subjects section, Targeted/Planned Enrollment Table, Study Schedule, Information for Nursing Form and Nutrition Information Form (see http://www.hopkinsmedicine.org/gcrc/) • a complete IRB application including all attachments: Form A, sponsor’s protocol, consent and assent form(s), Investigator’s Brochure, recruitment materials, etc.

7. copies of awards, contracts, other funding, and research agreements • before your study begins, initial IRB approval notice with IRB stamped consent and assent form(s) • contact John Reusing at 4-2717 to schedule a study start-up meeting

8. What We RequireDuring the Course of your Study • register your research subjects using GCRC Online - https://gcrc.med.jhmi.edu/gcrconline/ • Use EPIC to determine available clinic space • Contact John Reusing at 4-2717 to schedule GCRC Online and EPIC training

9. contact the Research Subject Advocate at 410-614-6323 or susanb@jhu.edu, and schedule a date, time and place for a consent observation at least once during the course of your study • provide a copy of each signed consent/assent form to each GCRC unit utilized

10. copies of the following materials at the time of submission to the JHM-IRB, WIRB, or BSPH-CHR: • amendment materials including an amendment request letter, providing: • a summary or outline of changes • a detailed rationale for each change • explanations as to why amendments are necessary to address the original hypotheses/experimental questions (i.e., why the initial approach was not adequate as presented in the original proposal) • for changes affecting your use of GCRC resources, such as an increase in enrollment or additional testing, indicate in your amendment letter whether or not you are requesting the GCRC provide these additional resources • revised sponsor’s protocol with a summary of changes • revised GCRC application, protocol summary, and human subjects section incorporating the amendments • revised recruitment materials • responses to IRB-pending amendment approval notices • once approved, IRB amendment approval notice, stamped consent form and assent form(s), and any other approved documents

11. copies of the following materials at the time of submission to the JHM-IRB, WIRB, or BSPH-CHR: • continuing review materials including a cover letter, providing: • a summary or outline of changes • a detailed rationale for each change • explanations as to why amendments are necessary to address the original hypotheses/experimental questions (i.e., why the initial approach was not adequate as presented in the original proposal) • for changes affecting your use of GCRC resources, such as an increase in enrollment or additional testing, indicate in your amendment letter whether or not you are requesting the GCRC provide these additional resources • revised sponsor’s protocol with a summary of changes • revised GCRC application, protocol summary, and human subjects section incorporating the amendments • revised recruitment materials • responses to IRB-pending amendment approval notices • once approved, IRB amendment approval notice, stamped consent form and assent form(s), and any other approved documents

12. copies of the following materials at the time of submission to the JHM-IRB, WIRB, or BSPH-CHR: • protocol event reports, i.e., adverse event, IND safety reports and protocol violation/deviation reports • data and safety monitoring reports/minutes • revised investigator’s brochures, package inserts • termination report Please send the GCRC copies of all memorandums received from the JHM-IRB, WIRB, or BSPH-CHR acknowledging receipt of the above mentioned reports and documents.

13. notify the GCRC when you have completed all participant visits and are no longer using GCRC resources

14. For Studies Approved bythe NBRU PRS • address all amendment requests and continuing review applications to Dr. Michael Cataldo, GCRC/NBRU Associate Director

15. What We Require Annually • a summary of your project including any publications, number of subjects enrolled to date, and updates to your funding/other support

16. What We Require During the Course of your Study as well asat Study Conclusion • credit the GCRC in publications: Supported by the Johns Hopkins University School of Medicine General Clinical Research Center, Grant # M01-RR00052, from the National Center for Research Resources/NIH

17. Studies Conductedin the SKCCC • Submit all documents to the CRO per their guidelines • Copy the GCRC on all submissions to the CRO • Revise GCRC documents accordingly

18. Justification for GCRC Requirements • Recommendations to General Clinical Research Centers for Patient Safety in Clinical Research - http://www.ncrr.nih.gov/clinical/gcrcpatientsafety20010622.asp#VI • The RSA is to ensure that the IRB- and GAC-approved monitoring plan is fully implemented and that the protocol carried out at the GCRC complies with the IRB- and GAC-approved protocol.

19. NCRR's program guidelines for GCRCs http://www.ncrr.nih.gov/clinical/crguide2004/guide17March2004.pdf • The primary function of the RSA is to ensure that studies on the GCRC are designed and conducted safely and ethically with protection of human subjects accorded the highest priority. • The RSA develops and guides implementation of policies and procedures for timely and appropriate reporting of adverse events, development and adherence to the Data and Safety Monitoring (DSM) Plan, approval and recording of all protocol amendments and changes in informed consent documents, performance of regulatory responsibilities in a complete and timely manner, and conduct of the research as written in the most recently approved protocol.

20. Program Direction Christopher Saudek, M.D. (410) 955-2132 csaudek@jhu.edu Michael Cataldo, Ph.D. (443) 923-2850 cataldo@kennedykriegcr.org Charles Flexner, M.D. (410) 955-9712 flex@erols.com Pamela Zeitlin. M.D., Ph.D. (410) 955-2035 pzeitli@jhmi.edu Ian Flinn, M.D., Ph.D. (410) 614-5542 iflinn@jhmi.edu Administration Administrative Manager Gerald A. Stacy (410) 614-2717 gstacy@jhu.edu Administrative Assistant Shernice Madison (410) 614-2717 smadison@jhu.edu Neurobehavioral Research Unit Bridget Johnson (443) 923-2852 johnsonb@kennedykrieger.org Research Nutrition Manager Susan Oh, M.S., M.P.H., R.D. (410) 955-5189 susanoh@jhmi.edu Informatics Systems Manager David G. Holmack (410) 955-0409 david.holmack@jhu.edu GCRC Contacts

21. Nurse Managers Adult Outpatient Unit Jared Christopher, R.N., B.S.N. (410) 955-2760 jaredc@jhmi.edu Pediatric Clinical Research Unit Mary Ann Sartain, R.N., M.S.N. (410) 955-5245 Msartain@jhmi.edu Adult Inpatient Unit Erin Turner, R.N., M.S.N. (410) 955-5875 eturner2@jhmi.edu Research Nurse Specialist Suzanne Dunphy, R.N., B.S.N. 410-955-5550 sdunphy@jhmi.edu Research Subject Advocate Program Research Subject Advocate Susan R. Bonura, MPA, CCRP (410) 614-6323 susanb@jhu.edu Faculty Advisors to the RSA Wendy Post, M.D. Assistant Professor of Medicine (410) 955-1780 wpost@jhmi.edu James F. Casella, M.D. Rainey Professor of Pediatric Hematology Chair, Pediatric Hematology (410) 955-6132 jcasella@jhmi.edu GCRC Contacts