REGULATORY B T BMC/BU MEDICAL C RESEARCH S
Regulatory Binder Tabs for BU/BMC Clinical Research StudiesVersion 3 7/1/2019REGULATORY BINDER TABS FORBMC/BU MEDICAL CAMPUS CLINICALRESEARCH STUDIESVersion 3.0July 1, 2019This tool is provided to you by the Clinical Research Resources Office. To downloadcustomizable templates to use with this binder, please visit the Resources page of theCRRO website at: www.bumc.bu.edu/crro.* Denotes documentation that is required only for certain types of studies.
Regulatory Binder Tabs for BMC/BU Medical Campus Clinical Research StudiesVersion 3.0; 7/1/2019REGULATORY BINDER TABSTab 1: IRB Review DocumentationTab 2: Study Protocol and Supporting DocumentsTab 3: Informed Consent Forms and Supporting DocumentsTab 4: Case Report Forms (CRFs) / Data Collection ToolsTab 5: Study ParticipantsTab 6: Adverse Event (AE) Monitoring and ReportingTab 7: Monitoring/Auditing/Site InitiationTab 8: Correspondence and Meeting MinutesTab 9: Study-related SOPs/MOPsTab 10: Study StaffTab 11: LaboratoryTab 12: Drug/Device AccountabilityTab 13: FDA 1572 Forms and Financial Disclosure Forms (FDFs)Tab 14: IND Maintenance for Investigator IND Holders(Investigators who are also Sponsors)Tab 15: IDE Maintenance for Investigator IDE Holders(Investigators who are also Sponsors)Tab 16: Single IRB – Relying Institution SiteTab 17: Single IRB – Lead Study Team SiteTab 18: Miscellaneous (Agreements, CoC, Equipment calibration, etc.)Tab 19: Notes-to-File/Deviation Reports/CAPAsTab 20:
Regulatory Binder Tabs for BMC/BU Medical Campus Clinical Research StudiesVersion 3.0; 7/1/2019Tab 1: IRB Review DocumentationIRB membership: The IRB roster documents that the IRB’s composition is in compliance withDepartment of Health and Human Services (DHHS) and FDA regulations and Good ClinicalPractice (GCP) guidelines, as applicable.Federalwide assurance (FWA): Federalwide assurance (FWA) from DHHS through the Office forHuman Research Protections (OHRP) is documentation that the institution commits to complyingwith requirements set forth in Protection of Human Subjects regulations at 45 CFR part 46.An institution must have an FWA in order to receive HHS support for research involving humansubjects. Each FWA must designate at least one IRB registered with OHRP. Before obtaining anFWA, an institution must either register its own IRB (an “internal” IRB) or designate an alreadyregistered IRB operated by another organization.IRB documentation of approvals: Documents initial and continuing approval of the research andapplicable changes to the research (including initial application, amendments, progress reports,reportable events, exceptions, final close out report, etc.).Check here if IRB review documentation is maintained in an electronic IRB submissionsystem that is accessible by study staff.If your study has multiple sites, and you are using a single IRB as the IRB of record (i.e. a reviewingIRB that is different from the local institution), use Tabs 16 and 17: Tab 16: Single IRB – Relying Institution Site Tab 17: Single IRB – Lead Study Team SiteOptional Customizable Documentation Templates for this sectionIRB Submission Tracking LogException Submission LogCommunications LogReferences 21 CFR 312.66 Assurance of IRB review21 CFR 56.107 IRB membership21 CFR 56.109 IRB review of research45 CFR 46.103 IRB assurance45 CFR 46.107 IRB membership45 CFR 46.109 IRB review of research45 CFR 46.114(b)(1) Cooperative researchICH GCP 3.0 IRBICH GCP 4.4 Communication with IRBICH GCP 4.5.2 Compliance with ProtocolICH GCP 4.10 Progress ReportsICH GCP 5.11 Confirmation of Review by IRB ICH GCP 8.3.2 Essential documents, Revisions toprotocol & consents ICH GCP 8.3.3 Essential documents, Approval of IRB FDA Guidance for IRBs, Clinical Investigators, andSponsors: IRB Continuing Review After ClinicalInvestigation Approval, February 2012 BU/BMC HRPP Policies & Procedures – 11.2 NIH Single IRB Policy for Multi-site ning/goodclinical-practice-gcp-certification/
Regulatory Binder Tabs for BMC/BU Medical Campus Clinical Research StudiesVersion 3.0; 7/1/2019Tab 2: Study Protocol and Supporting DocumentsStudy Protocol & Protocol amendments: Protocol and protocol-related documents. All approved versions of study protocolOutdated versions are stored: Protocol Signature page: signatories sign their approval/promise to comply with the protocol. Copy of NIH Grant ApplicationFiled elsewhere: Participant recruitment/educational materials may be filed under Tab #3: Informed ConsentForms & Supporting Documents. Data Safety Monitoring Plan (DSMP): Your DSMP may be part of your study protocol; it mightalso be a separate document. Keep all versions of the DSMP.o If you have a Data Safety Monitoring Board (DSMB) or other independent outsidemonitoring group you should have a “Charter” document that describes theprocesses to be followed by the group.Filed elsewhere: Some NIH Institutes/Centers require a Study Accrual and Retention Plan (SARP) for newgrants. This plan can be saved here.Filed elsewhere:Investigator Drug Brochure (IB) (or Package Insert if the drug is already marketed):The IB provides information on everything that is known about the study drug based on previouslaboratory, animal, and human. The package insert can be used if the drug is already FDAapproved.These documents (IB and/or package insert) should be readily available to all study staff; it is thesite’s reference regarding action of the drug and potential side effects. All approved versions of the IB or updated package inserts.Current/Outdated versions are stored: Signed receipt form for IB and updates. This is industry best practice, not a regulatoryrequirement. It is one way the sponsor can document that new IBs were received byinvestigators. The sponsor should have copies of all sites’ receipt forms on file. Individualinvestigators may keep their copy as documentation of receipt of the IB.References ICH GCP 4.5 Investigator compliance with protocolICH GCP 5.1.2.2 Updating the Investigator’s brochureICH GCP 7.0 Investigator’s brochureNIH Policy for Data and Safety Monitoring, June 10,1998 Further Guidance on a Data and Safety Monitoring forPhase 1 and Phase 2 Trials, June 5, 2000 FDA Guidance for Clinical Trial Sponsors:Establishment and Operation of Clinical Trial DataMonitoring Committees, March, 2006
Regulatory Binder Tabs for BMC/BU Medical Campus Clinical Research StudiesVersion 3.0; 7/1/2019Tab 3: Informed Consent Forms and Supporting DocumentsStudy consent forms: Documents which consent form versions were approved and valid atvarious points during the study. All approved versions of any consent forms used in the study (including translations, shortforms, screening consents, tissue storage/banking, etc.) Keep copies of outdated approved versions as well.Older versions filed elsewhere:(If you save hardcopy versions of outdated consent forms, make it clear on the file that these versions are out ofdate, and should not be used to consent current research participants.)Study participant recruitment and educational materials: These materials may be consideredpart of the consent process. Keep all approved versions as documentation that all materialsprovided to participants have been IRB-approved as appropriate components of the consentprocess. All approved versions of recruitment and educational materials, including flyers, brochures,advertisements, websites, etc. Keep copies of outdated approved materials as well.Older versions filed elsewhere:References 21 CFR part 50 Protection of Human Subjects 21 CFR part 56 IRBs 45 CFR 46.116 General requirements for informedconsent 45 CFR part 46 subpart D Additional Protections forChildren FDA Informed Consent Information Sheet – Guidancefor IRBs, Clinical Investigators, and Sponsors (Draft),July 2014 FDA Information Sheet Guidance: A Guide toInformed Consent FDA Information Sheet Guidance: Recruiting StudySubjects FDA Information Sheet Guidance: Payment toResearch Subjects FDA Guidance: Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers,December 2016ICH GCP 3.0 IRBsICH GCP 4.5 Compliance with protocolICH GCP 4.8 Informed Consent of Trial SubjectsICH GCP 4.9 Records and ReportsICH GCP 4.10 Progress reportsICH GCP 5.11 Review by IRBICH GCP 8.3.2 Essential documents, Info given to trialparticipantsICH GCP 8.3.3 Essential documents, IRB approval ofICFsOHRP Policy Guidance: Informed Consent
Regulatory Binder Tabs for BMC/BU Medical Campus Clinical Research StudiesVersion 3.0; 7/1/2019Tab 4: Case Report Forms (CRFs)/Data Collection ToolsAll past and present working versions of CRFs and CRF documentation completionguidelinesContained in this binderFiled elsewhere or stored electronically:N/AAll past and present working versions of source data collection tools: Typically, you woulddevelop and use a data collection tool to collect source data pertaining to your study. The datamay then be transcribed onto the sponsor-provided or internally-developed CRFs (which may bein electronic or hardcopy form).For example, you may develop a source data collection tool to collect vital signs, weight, height,pregnancy testing results, etc. performed at a screening visit. You should file completed forms inparticipant-specific files (not in the Regulatory Binder), but it is useful to keep all versions of yourdata collection tools so that it is clear what data was collected at what timepoints. These toolsshould be updated as needed to reflect changes to the protocol. Data collection tools includequestionnaires, surveys, subject diaries, and tools you use to record data from the medical record.Your data collection tools should be identified by a version number and date.Contained in this binderFiled elsewhere or stored electronically:N/AReferences 21 CFR 312.62(b) Case histories ICH GCP 1.11 CRFs definition ICH GCP 4.9 Records and Reports
Regulatory Binder Tabs for BMC/BU Medical Campus Clinical Research StudiesVersion 3.0; 7/1/2019Tab 5: Study ParticipantsInformation on individual study participants is typically maintained in participant specific files orcharts (not in the regulatory documentation or “binder”). Participant-specific files should includesigned consent forms, participant-specific source documents, and completed CRFs, etc. Ensure that participants are consented prior to any research procedures being performed(this includes collection/recording of identifiable health data from telephone or in-personscreening). For those participants who were screened but did not enroll, maintain information on reasonswhy. This information can be useful in assessing effectiveness of recruitment strategies.For NIH-supported research, information on race/ethnicity/sex should be collected to documentcompliance to NIH policy on inclusion of women and minorities in clinical research.Screening/Enrollment Log:Filed elsewhere:A list of individuals screened and their eligibility and enrollment status.Withdrawal/Termination Log:Filed elsewhere:A list of participants who withdrew or were terminated and reasons why.Participant Identification Log:Filed elsewhere:Per ICH GCP 8.3.21 a confidential list of all participants who are enrolled on a trial should be kept,including the names/contact information of the individuals linked to participant ID numbers.This list should be kept in a secure location with limited access.Optional Customizable Documentation Templates for this sectionScreening/Enrollment LogStudy Withdrawal/Termination LogParticipant Identification LogReferences ICH GCP 8.3.20 Essential documents, subjectscreening log ICH GCP 8.3.21 Essential documents, subjectidentification code list FDA Guidance for Sponsors, Clinical Investigators,and IRBs – Data Retention When Subjects Withdrawfrom FDA-regulated Clinical Trials, Oct 2008 OHRP Guidance on Withdrawal of Subjects fromResearch: Data Retention and other Related Issues,Sept. 21, 2010 FDA Information Sheet Guidance for IRBs and ClinicalInvestigators: Recruiting Study Subjects FDA Information Sheet Guidance for IRBs and ClinicalInvestigators: Screening tests prior to enrollment NIH Policy and Guidelines on the Inclusion of Womenand Minorities as Subjects in Clinical Research –Amended, October, 2001
Regulatory Binder Tabs for BMC/BU Medical Campus Clinical Research StudiesVersion 3.0; 7/1/2019Tab 6: Adverse Event (AE) Monitoring and ReportingThe BMC/BU Medical Campus IRB requires reporting of Unanticipated Problems (UPs)associated with fatal or life-threatening events within 7 days of the site learning of the event.Adverse Events (AEs) that are not UPs should be reported to the IRB at the time of continuingreview.Note that for studies where the BMC/BU Medical Campus IRB has ceded review to another IRB,you must follow the reporting requirements of the Reviewing IRB in addition to reporting the UP tothe BMC/BU Medical Campus IRB.Internal AE/UP Reporting Tracking Log Track that you have reported the AE/UP occurring at your site to all required entities as applicableper your protocol and DSMP. AE reports and AE source documentation should be filed in participant-specific files.Safety Report Tracking LogTracks/organizes receipt of IND Safety Reports or IDE Unanticipated Device Effects Reports (orother reports if not under an IND or IDE) that occur at external sites.Data Safety Monitoring Board (DSMB) reports (or other monitoring committee)Communications LogCorrespondence related to reporting of AEs and SAEs, deviations and other reportable events tothe IRB, sponsor, etc.Optional Customizable Documentation Templates for this sectionInternal AE Report Tracking LogSafety Report Tracking LogCommunications LogProtocol Deviation LogReferences Guidance for Industry and Investigators: SafetyReporting Requirements for INDs and BA/BE studies,FDA, December, 2012 OHRP Guidance on Reviewing and Reporting UPsInvolving Risks to Subjects or Others and AEs, Jan.15, 2007 21 CFR 312.32 IND Safety reports 21 CFR 812.50 (b) (1) Unanticipated device effectsreports ICH GCP 4.11 Safety reporting ICH GCP 5.17 Adverse Drug Reaction Reports ICH GCP 8.3.16, 8.3.17, 8.3.18 Essential documents,AE reporting FDA Guidance for Clinical Investigators, Sponsors,and IRBs: AE Reporting to IRBs ., Jan. 2009 NIH Guidance on Reporting Adverse Events to IRBsfor NIH-Supported Multicenter Trials, June 11, 1999
Regulatory Binder Tabs for BMC/BU Medical Campus Clinical Research StudiesVersion 3.0; 7/1/2019Tab 7: Monitoring/Auditing/Site InitiationThe following reports should be a part of the regulatory files in those studies that are monitored bythe sponsor or CRO or other monitoring entity. It is useful to keep track of all monitor/auditor sitevisits and applicable correspondence regarding the site visits in the regulatory files. Use the SiteVisit Log and the Communications Log for documentation of site visits and relatedcorrespondence.Monitoring reports and site response (as necessary)Filed elsewhere: Pre-trial monitoring report: Documents that the site is suitable for the trial. Study site Initiation Report: Documents that the protocol and procedures were reviewed withsite by sponsor study monitor and the site was trained on the protocol. File the agenda,attendance, minutes for the meeting. File training materials in the Study Staff tab (10). Interim Monitoring Reports: Documents site visits and findings of the sponsor study monitorand site response to findings (corrective actions, as necessary). Close-out report: Documents that the study is complete at this site and that all issues/querieshave been resolved. The investigator is reminded at this visit of his/her responsibilities tomaintain study documentation for the required time period per regulations and/or sponsorrequirements.Optional Customizable Documentation Templates for this sectionSite Visit LogCommunications LogReferences 21 CFR 312.54 (d) Selecting monitorsICH GCP 5.18 MonitoringICH GCP 5.19 AuditingICH GCP 8.3.10 Essential documents, monitor visitreports FDA Guidance for Industry: Oversight of ClinicalInvestigations – A Risk-based Approach to Monitoring,August, 2013 FDA Guidance for Industry: InvestigatorResponsibilities – Protecting the Rights, Safety andWelfare of Study Subjects, October, 2009 CRRO Tools for Self-assessments (CRRO website:www.bumc.bu.edu/crro)
Regulatory Binder Tabs for BMC/BU Medical Campus Clinical Research StudiesVersion 3.0; 7/1/2019Tab 8: Correspondence and Meeting MinutesCorrespondence related to study management and conduct should be documented. You maydecide to keep all correspondence here, or you may decide to keep certain correspondence (suchas IRB, pharmacy, laboratory, etc.) under tabs specific to those entities. Documentation shouldinclude the date and a list of people/groups involved in the correspondence. Correspondencedocumentation may also be kept in separate binders or files (including electronic). Below is a listof possible correspondence that may be maintained here. Communications about a specificparticipant should be filed with the source documents in that participant’s research record.Correspondence with Sponsor/CRO/Funding Source:Filed elsewhere:Documents agreements between sponsor/CRO and site regarding any relevant issue pertaining toconduct of the trial (may include letters, notes documenting phone calls, meeting notes, e-mails,faxes etc.).Correspondence with Site team and/or other sites:Filed elsewhere:Documents agreements regarding study conduct and processes that occur among staff at localsite or between sites (such as in PI and/or coordinator conference calls).IRB Correspondence:Filed elsewhere:Meeting/Conference call minutes:Filed elsewhere:Misc. Correspondence:Filed elsewhere:Optional Customizable Documentation Templates for this sectionPhone Call Summary ReportCommunications LogReferences ICH GCP 4.96 Agreements between sponsor and investigator/institution ICH GCP 8.3.11 Essential documents, communications
Regulatory Binder Tabs for BMC/BU Medical Campus Clinical Research StudiesVersion 3.0; 7/1/2019Tab 9: Study-related SOPs/MOPsSOP List: File study-specific standard operating procedures (SOPs). These may also be knownas Manual of Procedures (MOP), Study Operations Manual (SOM) or some other similar name.They include procedures for various aspects of the study, such as handling of study test article,lab processing procedures, screening, consenting, randomization, unblinding procedures, etc.,and are often supplied by the sponsor. Sites may also develop their own site-specific SOPs inaddition to sponsor-provided SOPs. These help to operationalize the study protocol and ensurethat all study-specific procedures are performed the same way throughout the study.Keep all final versions (even if they are updated), so that procedures guiding research at a certainpoint in time can be used to validate study conduct during that time. Outdated versions should belabeled as such.Check here if SOPs (MOPs, SOMs, etc.) are filed elsewhere:Optional Customizable Documentation Templates for this sectionSOP Table of ContentsReferences ICH GCP 1.55 Standard Operating Procedures ICH GCP 4.7 Randomization Procedures and Unblinding ICH GCP 8.2.17 Essential documents, decoding for blinded trials
Regulatory Binder Tabs for BMC/BU Medical Campus Clinical Research StudiesVersion 3.0; 7/1/2019Tab 10: Study StaffThis section contains documentation regarding appropriate delegation of study-related tasks bythe PI, and the adequate qualifications and training of those staff regarding the tasks to which theyhave been assigned. Documentation in this section helps validate that the PI adhered to his/herresponsibilities to personally conduct or supervise the conduct of the research and to protect therights, safety, and welfare of study participants.CVs and clinical licenses for PI, Sub-Is and site staff: Provides evidence of qualifications t
Jul 02, 2019 · Regulatory Binder Tabs for BMC/BU Medical Campus Clinical Research Studies Version 3.0; 7/1/2019 Tab 1: IRB Review Documentation IRB membership: The IRB roster documents that the IRB’s composition is in compliance with Department of Health and Human Services (DHH
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