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

http://www.hopkinsmedicine.org/gcrc/

Who We Are

Funded by a competing grant (M01 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

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)

We Also Provide

Computer and Data Management Support Biostatistical Support Nutrition Services Training and Education Ancillary Services Research Subject Advocate Program

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

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.

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

What We Require During 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

contact the Research Subject Advocate at 410-614-6323 or susanb@jhu.edu

unit utilized , 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

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 • for changes affecting your use of GCRC resources, such as an

amendment letter whether or not you are requesting the GCRC

• 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

copies of the following materials at the time of 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

time of submission to the JHM-IRB, 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

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

For Studies Approved by the NBRU PRS

address all amendment requests and continuing review applications to Dr. Michael Cataldo, GCRC/NBRU Associate Director

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

What We Require During the Course of your Study as well as at 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

Studies Conducted in the SKCCC

Submit all documents to the CRO per their guidelines Copy the GCRC on all submissions to the CRO Revise GCRC documents accordingly

Justification for GCRC Requirements

Research Centers for Patient Safety in http://www.ncrr.nih.gov/clinical/gcrcpatie ntsafety20010622.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

NCRR's program guidelines for GCRCs http://www.ncrr.nih.gov/clinical/crguide2004/gui de17March2004.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.

GCRC Contacts

Program Direction Christopher Saudek, M.D.

(410) 955-2132 csaudek@jhu.edu

Administration

Administrative Manager

Gerald A. Stacy (410) 614-2717 gstacy@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

Administrative Assistant

Shernice Madison (410) 614-2717 smadison@jhu.edu

Neurobehavioral Research Unit

Bridget Johnson (443) 923-2852 johnsonb@kennedykrieger.org

Ian Flinn, M.D., Ph.D.

(410) 614-5542 iflinn@jhmi.edu

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

Nurse Managers Research Subject Advocate Program

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

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