Annual Review / Progress Report Date(S)

Human Research Protection Program Good Clinical Practice Self - Study File ReviewWorksheet

Reviewer:

Review Date:

Study Title:

Initial Approval Date: Current Approval Date: Annual Review / Progress Report Date(s):

Amendment Number and Date(s):

Current ICF version:

Current Investigator Brochure:

Annual Safety Update Report dated:

Principal Investigator:

Sub Investigator(s) and or Co Investigator(s):

Research Coordinator(s):

Site Specific Serious Adverse Events: Pre Review Discussion Attendees and comments: Source Documentation: Case Report forms / Data Collection forms: Paper Electronic Legible Accurate Complete

Regulatory Files Item Yes No N/A Comments Is a regulatory binder maintained? IRB Approval and correspondence IRB member roster Investigator’s brochure or package insert FDA Form 1572 or 1571 IDE application or contract Original Protocol/ Research Plan

of 3 SEQuR Worksheet Self Study Review Effective Date 10/01/2010 Supersedes NA All versions of Protocol Original Informed Consent All versions of ICF Original signed ICFs Serious and Unexpected AEs IND safety reports Drug/device accountability records CRFs/Data collection forms Sponsor correspondence Sponsor monitoring log/reports Lab certification Laboratory specimen handling on site? CLIA waiver? Lab directors CV Range of normal values Signature/ Responsibility list Final study report FDA correspondence Documentation of CITI Training Financial Disclosure Guidelines for storage of drug/device Shipping receipts for drug/device delivery/pickup Is a Case History file present for each subject? Does the Case History file contain the Case Report Forms for each subject? Does each Case History file include documentation that IC was obtained prior to participation in the study? GCP / ICH requirements PI and Sub-investigator CVs updated in the last 2 yrs, signed and dated Screening Log – Number of subjects excluded : 34 Screen Failures Enrollment Log - complete Number of subjects enrolled : 7 Process for payments to subjects Are Investigators and study staff maintaining study records documenting that research procedures were followed? Is the data collected maintained

of 3 SEQuR Worksheet - Self Study Review Effective Date 10/01/2010 Supersedes NA in a secure location? Has access to the data been limited to the individuals listed in the IRB approved protocol and or consent form? Is HIPPA form signed and present? If blinded trial is code maintained in secure location separate form subject identifiers? Subject files Any invalid Informed Consent Forms? Dates Signatures Received a copy Children sign Assent? Non English in native language? Research Procedures prior to IRB approval? All Inclusion Exclusion Criteria Met? Source Documents available for each subject and data point? Corrections to CRFs and Source correct per GCP All signatures/initials in source are dually noted as the responsible party on the responsibility log and IRB approved personnel? Follow up items identified by monitor on monitoring visits attended to in appropriate time frame? Medical Histories documented to reflect I and E criteria Documentation exists to confirm new staff is trained by the PI on protocol. Monitoring visit follow up letters Signed and dated by PI

of 3 SEQuR Worksheet - Self Study Review Effective Date 10/01/2010 Supersedes NA