ࡱ> ~}M v bjbj!! 4DKGiKGiX  8L8D^||"$$$$$$$VHH4]""F`lpVN̄Ts0  N^ & HH  X f: Suggested Regulatory Binder Tabs for a Binder (hard copy) Format Introduction Federal and state regulations, institutional policy, and good clinical and research practices require investigators to keep documents related to human subjects research. These suggested regulatory binder tabs may be used to help you organize your study documents. Please note, some sponsors, contracts, or federal agencies may require that investigators keep additional documents that are not specifically referenced on this list. We have organized topics tabs into four categories; you may use these or another system that makes sense to you: 1. IRB Submissions/Approved Documents 2. Protocol Operations 3. Sponsor 4. Regulatory Oversight If you have questions or need clarification, please feel free to contact Shirlene Harris, the Senior Quality Improvement Specialist at 410-502-7781, or send an email to shharris@jhu.edu. IRB Submissions/Approved Documents Study Research Plan/Protocol (All versions) The most updated, current approved protocol version. All superceded versions of the research plan. Informed Consent & Assent Forms The most updated, current approved versions of consent/assent forms. All expired/superceded versions of the consent/assent forms. Consent Revision log (optional, but recommended) tracking changes to consent/assent forms, the date submitted for IRB review, and date approved by the IRB. Recruitment Materials All current IRB approved recruitment materials All superseded versions of recruitment materials. Recruitment Revision Log (optional) tracking changes to materials, data submitted to the IRB, and date approved by the IRB Instruments All current IRB approved instruments All superseded versions of instruments. Recruitment Revision Log (optional) tracking changes to instruments, data submitted to the IRB, and date approved by the IRB Adverse Events & Unanticipated Problems (Problem Event Reports) Pertinent correspondence regarding event and report Final IRB acknowledgment Letter Adverse Event and Unanticipated Problem Log (optional) Protocol Deviations Documents showing dates and reasons for any deviation from the protocol. Because the IRB only requires that these be submitted annually, you may find it useful to keep a table which indicates which tracks dates of submission. Note: The PI should be familiar with the IRB definitions of protocol deviation and investigator non-compliance in JHSPH IRB Policies 103.06 and 103.07. IRB Documentation Complete applications and documentation for initial review, continuing reviews, and amendments, problem event reports, final study report All correspondence with the IRB Local IRB approvals, research site permissions IRB Tracking Log (optional) Tracks submissions, IRB actions, PI responses and correspondence DSMB Reports and Summaries Copies of all reports and summaries. Documentation of DSMB charter if separate from protocol/research plan List of Data Safety Monitoring Board Members and affiliations Case Report Forms Current and complete set of blank case report forms (CRFs) Out of date case report forms (CRFs) Source document list Protocol Operations Subject Screening and Enrollment Screening log Subject enrollment log Standard Operating Procedures Current version of the SOPs. All superceded versions of the SOPs. Notes-To-File A note or memo that documents and explains any discrepancies, clarifies any questionable data, or study procedures. A note or memo that documents where certain documents are stored in places other than the regulatory binder (i.e. a note to file indicating that signed case report forms are kept in study subjects files, etc.). Study/Subject Documents Blank copy of surveys and questionnaires Subject Inclusion/Exclusion checklist Study visit checklist Study Staff Information Roles & Responsibilities Log Staff Signature Log CVs Training Certifications (Human Subjects Research, GCP, HIPAA, etc.) Sponsor (e.g. NIH, USAID, BMGF, etc.) Copy of the approved sponsor grant application or contract. All Progress Reports submitted to sponsor. All forms submitted to sponsor pertaining to human subjects research. All correspondences with sponsor (the retained communications includes all required reports, e-mails, faxes, memoranda, and letters. In addition, we encourage logging phone conversations to record when conversations take place, and generating minutes to document the substance of these communications.) Regulatory Oversight (FDA, CLIA, etc.) FDA Form 1572 & 1571 Copies of all versions of FDA Form 1572 (Statement of Investigator) for all involved investigators (documents must be updated with the study sponsor each time there is a change to the information originally provided. Copies of all versions should be maintained. Copy of the Investigational New Drug Application (FDA Form 1571), if the PI is also the sponsor; and, all versions of the FDA Form 1571 submitted with amendments to the FDA. IND/IDE Annual Reports to the FDA for Investigator-Sponsored Studies Monitoring Log [Monitoring reports are Optional] Monitoring Log (required for all FDA studies) documents all monitoring visits and reviews (e.g. site visits, FDA audits). Drug/Device Accountability Log A record to document the shipment, receipt, use of and disposal of all investigational drugs/devices used for the study. Laboratory Documentation Normal Value Range(s) for medical, laboratory, technical procedures and/or tests included in the protocol Certification/Accreditation for all medical, laboratory, technical procedures and/or test included in the protocol Lab Directors Curriculum Vitae (CV) CV should be current within 2 years. CLIA (Clinical Laboratory Improvement Amendments) Certification Biosafety Registration information Certification of Analysis document which lists the tests, methods, specifications, and results of the in-process, bulk, and final lot release tests for each bulk and/or lot of drug, chemical, or vaccine manufactures. 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