working with the johns hopkins university general clinical research center (gcrc)

Working withWorking withThe Johns Hopkins The Johns Hopkins

UniversityUniversityGeneral Clinical General Clinical Research CenterResearch Center

(GCRC)(GCRC)

Working withWorking withThe Johns Hopkins The Johns Hopkins

UniversityUniversityGeneral Clinical General Clinical Research CenterResearch Center

(GCRC)(GCRC)

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

Who We AreFunded by a competing grant (M01-RR0052) from the NIH/NCRRServe as a centralized clinical research resource to all Hopkins facultySupport investigator-initiated, federally funded clinical research projectsSupport non-funded pilot studies, feasibility trials, and industry-sponsored research

What We ProvideInitial 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 ProvideComputer and Data Management SupportBiostatistical SupportNutrition ServicesTraining and EducationAncillary ServicesResearch Subject Advocate Program

Where We Provide Services

PCRU – Pediatric Inpatient and Outpatient Unit, Blalock 3OPD – Adult Outpatient Unit, Carnegie 3Adult Inpatient Unit, Osler 5NBRU – Neurobehavioral Research Unit, Kennedy-Krieger InstituteSKCCC – Weinberg Cancer CenterAdministrative 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 agreementsbefore 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 RequireDuring the Course of

your Studyregister your research subjects using GCRC Online - https://gcrc.med.jhmi.edu/gcrconline/

Use EPIC to determine available clinic spaceContact 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, and schedule a date, time and place for a consent observation at least once during the course of your studyprovide 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 reportsdata and safety monitoring reports/minutesrevised investigator’s brochures, package insertstermination reportPlease 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 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

Studies Conductedin the SKCCC

Submit all documents to the CRO per their guidelinesCopy the GCRC on all submissions to the CRORevise GCRC documents accordingly

Justification for GCRC RequirementsRecommendations 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.

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.

GCRC ContactsProgram Direction

Christopher Saudek, M.D.(410) 955-2132csaudek@jhu.edu

Michael Cataldo, Ph.D.(443) 923-2850cataldo@kennedykriegcr.org

Charles Flexner, M.D.(410) 955-9712flex@erols.com

Pamela Zeitlin. M.D., Ph.D.(410) 955-2035pzeitli@jhmi.edu

Ian Flinn, M.D., Ph.D.(410) 614-5542iflinn@jhmi.edu

AdministrationAdministrative Manager

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

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

Neurobehavioral Research UnitBridget Johnson(443) 923-2852johnsonb@kennedykrieger.org

Research Nutrition ManagerSusan Oh, M.S., M.P.H., R.D.(410) 955-5189susanoh@jhmi.edu

Informatics Systems ManagerDavid G. Holmack(410) 955-0409david.holmack@jhu.edu

GCRC ContactsNurse Managers

Adult Outpatient UnitJared Christopher, R.N., B.S.N.(410) 955-2760jaredc@jhmi.edu

Pediatric Clinical Research UnitMary Ann Sartain, R.N., M.S.N.(410) 955-5245Msartain@jhmi.edu

Adult Inpatient UnitErin Turner, R.N., M.S.N.(410) 955-5875eturner2@jhmi.edu

Research Nurse SpecialistSuzanne Dunphy, R.N., B.S.N.410-955-5550sdunphy@jhmi.edu

Research Subject Advocate Program

Research Subject AdvocateSusan R. Bonura, MPA, CCRP(410) 614-6323susanb@jhu.edu

Faculty Advisors to the RSAWendy Post, M.D.Assistant Professor of Medicine(410) 955-1780wpost@jhmi.edu

James F. Casella, M.D.Rainey Professor of Pediatric

HematologyChair, Pediatric Hematology(410) 955-6132jcasella@jhmi.edu