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

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

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 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 to schedule a study start-up meeting

What We Require During the Course of your Study register your research subjects using GCRC Online Use EPIC to determine available clinic space Contact John Reusing at to schedule GCRC Online and EPIC training

contact the Research Subject Advocate at or 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

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

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

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.

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

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

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 Recommendations to General Clinical Research Centers for Patient Safety in Clinical Research - ntsafety asp#VI ntsafety 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.

NCRR's program guidelines for GCRCs de17March2004.pdf 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) Michael Cataldo, Ph.D. (443) Charles Flexner, M.D. (410) Pamela Zeitlin. M.D., Ph.D. (410) Ian Flinn, M.D., Ph.D. (410) Administration Administrative Manager Gerald A. Stacy (410) Administrative Assistant Shernice Madison (410) Neurobehavioral Research Unit Bridget Johnson (443) Research Nutrition Manager Susan Oh, M.S., M.P.H., R.D. (410) Informatics Systems Manager David G. Holmack (410)

GCRC Contacts Nurse Managers Adult Outpatient Unit Jared Christopher, R.N., B.S.N. (410) Pediatric Clinical Research Unit Mary Ann Sartain, R.N., M.S.N. (410) Adult Inpatient Unit Erin Turner, R.N., M.S.N. (410) Research Nurse Specialist Suzanne Dunphy, R.N., B.S.N Research Subject Advocate Program Research Subject Advocate Susan R. Bonura, MPA, CCRP (410) Faculty Advisors to the RSA Wendy Post, M.D. Assistant Professor of Medicine (410) James F. Casella, M.D. Rainey Professor of Pediatric Hematology Chair, Pediatric Hematology (410)