Download University of Pittsburgh Research Conduct and Compliance Office

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)