working with the johns hopkins university general clinical research center (gcrc)
TRANSCRIPT
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 [email protected], 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) [email protected]
Michael Cataldo, Ph.D.(443) [email protected]
Charles Flexner, M.D.(410) [email protected]
Pamela Zeitlin. M.D., Ph.D.(410) [email protected]
Ian Flinn, M.D., Ph.D.(410) [email protected]
AdministrationAdministrative Manager
Gerald A. Stacy(410) [email protected]
Administrative AssistantShernice Madison(410) [email protected]
Neurobehavioral Research UnitBridget Johnson(443) [email protected]
Research Nutrition ManagerSusan Oh, M.S., M.P.H., R.D.(410) [email protected]
Informatics Systems ManagerDavid G. Holmack(410) [email protected]
GCRC ContactsNurse Managers
Adult Outpatient UnitJared Christopher, R.N., B.S.N.(410) [email protected]
Pediatric Clinical Research UnitMary Ann Sartain, R.N., M.S.N.(410) [email protected]
Adult Inpatient UnitErin Turner, R.N., M.S.N.(410) [email protected]
Research Nurse SpecialistSuzanne Dunphy, R.N., [email protected]
Research Subject Advocate Program
Research Subject AdvocateSusan R. Bonura, MPA, CCRP(410) [email protected]
Faculty Advisors to the RSAWendy Post, M.D.Assistant Professor of Medicine(410) [email protected]
James F. Casella, M.D.Rainey Professor of Pediatric
HematologyChair, Pediatric Hematology(410) [email protected]