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University of Pittsburgh Research Conduct and Compliance Office Pre-Study Activities Checklist IRB #: Title: PI: Phone: Coordinator: Activity Study Initiation / Start Up Meeting Review protocol with principal investigator and all research staff Date of Meeting Minutes recorded Tour research sites to ensure adequate resources for protocol compliance and train ancillary personnel, i.e., MRI center, EEG, X-ray, CT scan Prepare original submission to IRB: Protocol Consent Document If waiver to document consent for screening: o Screening Script o Screening Questions Recruitment materials o Advertisements o Dear Doctor letters o Dear Patient letters Investigator Brochure Scientific Review Data Safety Monitoring Plan Financial Application/Fiscal Review Grant Additional Ancillary Review and approval if required: o CTRC (Clinical Translational Research Center) o ESCRO (Embryonic Stem Cell Research Oversight) o IDS (Investigational Drug Service) o rDNA/IBC (Recomb DNA/ Institutional Biosafety Committee) o RDRC (Radiation Review Committee) HUSC (Human Use Subcommittee) Approval/Agreement letters from participating sites Risk Level: Approved Enrollment: Phone: Date Completed Comments Study Tools Standard Operating Procedures (SOPs) Screening Log Initial Screening Form (Phone screen or initial visit) Documentation of Consent Process Eligibility Checklist Study Procedures Data Collection Forms Unanticipated Problem Form / Adverse Event Form Test Article Inventory /Accountability and Storage Form o Refrigerator / Freezer Temperature Log o Dispense / Return / Destruction Log Test Article / Subject Drug Administration Form “Note to File” Form HIPAA Authorization Form (if applicable) Delegation of Responsibility and Signature Form Progress Note Form Regulatory Files Investigator(s) Curriculum Vitae and copies of licenses (may be maintained in a central departmental location) IRB Submissions and Correspondence (includes Consent Forms) (maintained in OSIRIS) Sponsor (multicenter) Protocol and Correspondence Delegation of authority and signature log Unanticipated Problem Reports / Adverse Event Reports Training and Education Certificates of Staff (may be maintained in a central departmental location) Laboratory certifications and normal values Monitor visit reports and queries Data and Safety Monitoring Meeting Minutes Certificate of Confidentiality Additional Documents Required for FDA Regulated Research Correspondence with Federal Agencies o 1572 o 1571 o IND/IDE Applications / Approvals o Annual Progress Reports o General correspondence Investigator Brochure Test Article Inventory /Accountability Funding Documentation (Maintain separately)