ࡱ>  Fbjbj 7}c}cpB0YYYYYmmm8a m{"E%:%(%%%&&&$SzАeY&&&&&АYY%%5@0@0@0&Y%Y%:p@0&@0@0f%T('D&K0{̆͗'$͗͗Y&&@0&&&&&АА",&&&{&&&&͗&&&&&&&&& :   INCLUDEPICTURE "http://www.slu.edu/Images/marketing_communications/logos/left_logo_250.jpg" \* MERGEFORMATINET  Institutional Review Board 3556 Caroline Street Room C110 St. Louis, MO 63104 Phone 314-977-7744 irb@slu.edu Investigator Self-Assessment Checklist Principal Investigator: Reviewed By: IRB Protocol #: Current Approval Period: PURPOSE INTRODUCTION The IRB Quality Assurance Review (QAR) Program aims to promote high ethical and quality standards in the conduct of human subjects research. To support that aim, the QAR Program has issued this Investigator Self-Assessment Checklist to empower investigators to assess whether their research is being conducted in accordance with regulations and best practice. Elements on this checklist derive from federal regulations (DHHS and FDA), SLU IRB policies, and ICH Good Clinical Practice, the latter of which is most relevant to interventional studies and clinical trials. As such, some items may not be applicable to the work you do. You are free to complete only those items that apply to your research, and/or to add items you feel are missing from the list (e.g., unit-specific standard operating procedures). Weve included a Notes/Supporting Evidence field on the tool for you to list the documents that demonstrate each item is satisfied. Just as receipts are important to ensure all claims on your taxes are supported, having source documentation in research is essential. Thus, we strongly encourage gathering supporting evidence throughout this self-assessment. Some checklist items have been shaded in the yes/no column. When doing the assessment, if a shaded box is checked, the issue needs to be reported to the IRB Office via a Report Form as a protocol violation (see HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/guidelines_reportable_events.doc"SLU IRB Reporting Guidelines). While this may seem intimidating, the IRB realizes that errors in the conduct of research occur, and does not aim to be punitive when such items are reported; instead, the IRB typically commends the investigators for efforts taken to enhance the quality of their research. It is always better to self-report than have a finding emerge during an audit. The IRB does not otherwise need to be informed about the results of your assessment. Thank you for your commitment to best practice in research! If there are any questions about the checklist, if you need assistance customizing or implementing it, or if you are interested in requesting a QAR team visit to assess your research operation rather than doing it internally, please contact your IRB Office at 314-977-7744. RESEARCH TEAM YesNoN/ANotes/Supporting EvidenceAre all personnel working on the research project IRB approved?oooIs IRB/Human Subjects Research training on file for each research team member?oooIs there documentation of delegation of research roles and responsibilities for the research team?oooHave tasks been delegated to staff trained and qualified to perform the tasks?oooIs staff doing only the tasks that have been delegated to them, according to the IRB protocol?oooIs documentation of protocol training and mentoring (if applicable) on file?oooFOR CLINICAL STUDIESIs there a staff signature log on file?oooAre there copies of CVs on file for all members of the research team?oooAre the CVs up to date and signed?oooAre there medical licenses/certifications on file for all applicable study team members?oooIRB PROTOCOL ADHERENCE, AMENDMENTS, CONTINUING REVIEW In addition to initial review and approval, all subsequent modifications to the approved IRB Application/protocol must be approved by the IRB prior to implementation. This includes protocol amendments, consent form revisions, and study team or study location changes. Studies should also maintain active IRB approval without lapses; this is done by timely submission of continuing review forms. All correspondence with the IRB must be maintained on file (or electronically). YesNoN/ANotes/Supporting EvidenceAre all study procedures being conducted according to the approved current protocol?oooDid any research activities occur prior to IRB approval?oooWere all modifications/amendments approved by the IRB prior to implementation?oooWere there any lapses in IRB approval (failure to submit continuing reviews prior to expiration dates)?oooIf yes: were any study related activities conducted during the lapse period without IRB permission to do so?oooIf yes: were any subjects enrolled during the lapse period?ooo SUBJECT RECRUITMENT PROCEDURES Any advertisement that will be seen or heard by prospective subjects to solicit their participation in a study is considered direct advertisement for research subjects. This includes, but is not necessarily limited to: e-mail announcements, online advertisements, newspaper, radio, TV, bulletin boards, posters, and flyers that are intended for prospective subjects. The IRB must review and approve all methods and materials used to recruit study participants. YesNoN/ANotes/Supporting EvidenceAre all recruitment methods being used described in the IRB application?oooHave all recruitment materials been approved by the IRB? (This includes any or all ads, phone scripts, email scripts, or anything that is seen by the subject for recruitment purposes.)oooHave any unapproved advertisements been utilized for recruitment?oooAre all approved recruitment materials (original and all revisions) on file?oooWere changes made to recruitment materials without IRB approval?oooPRIVACY, DATA STORAGE & CONFIDENTIALITY YesNoN/ANotes/Supporting EvidenceIf you proposed to collect the data anonymously, has anonymity been maintained in the physical and electronic records? (Are identifiers tied to subject data?)oooIf the study uses a coding system with a master list (key) kept separately, is the master list being kept in accordance with the IRB approved protocol?oooIs the subject s privacy protected and are safeguards in place as approved by the IRB?oooAre hard copies (consent forms and source docs) stored in a secure, locked location?oooIs electronic data on a secure and protected computer? Are you aware of the security on your computer and server?oooAre electronic data files password protected or encrypted?oooIs access to computer, electronic files, and physical files limited to appropriate study personnel?oooWas the research data stored/disposed of as approved by the IRB in the IRB application?ooo SUBJECT DATA COLLECTION Study subjects are screened for involvement in a study based on IRB approved inclusion/exclusion criteria. The PI is responsible for ensuring that source documentation supporting eligibility is available in the subject's research record/subject file. YesNoN/ANotes/Supporting EvidenceIs there an eligibility checklist containing inclusion/exclusion criteria for all enrolled subjects?oooIs there source documentation to verify inclusion/exclusion criteria?oooDoes the eligibility criteria checklist for each subject include dated signature/initials of the person obtaining the information?oooFor any enrolled subjects that did not meet eligibility criteria, was a request for a protocol exception submitted to the IRB prior to enrollment?oooFor volunteers who did not meet eligibility (e.g. screen-failures), was identifiable information destroyed (unless IRB approved retention)?oooIs there a subject enrollment log?oooAre screening/enrollment logs complete and up-to-date?oooAre subject withdrawals and dropouts documented?oooAre entry criteria documented and eligibility confirmed prior to research-related procedures?oooIs data collection complete/accurate for each subject (e.g. no blank fields/missing data)?oooDoes the source documentation for each subject include dated signature/initials of the person obtaining the information for each subject?oooAre changes/cross-outs, additional comments (if any) in subject files routinely initialed and dated?ooo INFORMED CONSENT During the course of the study, changes to the IRB-approved protocol may necessitate a change to the consent form(s). These changes can include but are not limited to new safety information, revised study procedures, eligibility criteria, or text clarifications. All consent form revisions must be IRB-approved. IRB approval is documented by use of a stamp, containing a valid date and expiration date. A consent form that does not contain this approval stamp, or a consent form used after the expiration date, is considered invalid. It is essential that the study site use only the most recently approved version of the consent form to consent subjects. Whenever a new approved consent form is generated, and stamped with a valid date, it replaces the previously approved version. New versions are also generated (with or without change) at the time of continuing review. For the following, consent form = consents, assents, HIPAA AuthorizationsYesNoN/ANotes/Supporting EvidenceWas the currently approved & valid (stamped/watermarked) IRB-approved consent form used throughout the study?oooAre consent forms free of any handwritten changes or corrections?oooIs the subject's name written on the first page?oooAre all pages of the consent form on file for each subject?oooIf participant agreed to enroll, were all consent materials properly signed and dated?oooDid the participant (or a legal participant representative) sign his/her own consent form(s)?oooAre all yes/no, checkboxes, or similar options on the consent forms completed/initialed?oooAre all participant/participant representative lines appropriately signed?oooAre all PI/research team member lines appropriately signed?oooWas the research team member who obtained consent approved to do so in the IRB Application?oooDid the PI/research team member enter the same date as the participant on the consent form (if expected to do so in the IRB approved consent process)?oooAre original copies (not photocopied) of all consent forms signed and dated by participants kept in the research file?oooWas a copy of all signed consent documentation is given to the participant?oooIs there documentation of the participant's/participant representative receipt of a copy of the consent form (e.g., Enrollment Log or progress notes)?oooWas the informed consent form is signed prior to the initiation of any study procedures?oooAre consent forms stored as written in the IRB protocol, including measures to maintain confidentiality?ooo DATA SAFETY & MONITORING ruvwxy{jSB1B!h hD`B* OJQJ^Jph=!h hB* OJQJ^Jph=-h h<n0J#B* CJOJQJ^JaJph=,h h5B* CJOJQJ^JaJph=,h h<n5B* CJOJQJ^JaJph=,hhG05B* CJOJQJ^JaJph!D hh"CJOJQJ^JaJhh"OJQJ^J hh<nCJOJQJ^JaJ)jhh<nCJOJQJU^JaJhhG0OJQJ^Jvwxyz{JBB$a$gd<nHkdne$$If- 6P634-ayt"$$&P#$/Ifa$gd"Hkde$$If- 6P634-ayt"$&P#$/Ifgd"{ ; < t k$a$gd:-$a$gd: $a$gd: " -DM fffgd<n$ $d&dNPa$gd<n 8^`8gdzT;$a$gd<n   & ) * - 9 < K P S j k s t dzzzlYF1(h^h'!5B*CJOJQJ^Jph$hh<n5B*OJQJ^Jph$hh[i5B*OJQJ^Jphhh[i5OJQJ^JhhG0OJQJ^Jhh<nOJQJ^J!hh<nB*OJQJ^Jphhh<n5OJQJ^J&hh<n5>*CJOJQJ^JaJ&hh>S5>*CJOJQJ^JaJ&hh\]u5>*CJOJQJ^JaJ h% 5>*CJOJQJ^JaJ ) ZںڨړmZC55h=YCJOJQJ^JaJ-jhvNh:0JCJOJQJU^JaJ$hvNh:0JCJOJQJ^JaJ/jehvNhiCJOJQJU^JaJhiCJOJQJ^JaJ)jhvNh:CJOJQJU^JaJ#hvNh:5CJOJQJ^JaJ#hNh:CJH*OJQJ^JaJh#CJOJQJ^JaJ hvNh:CJOJQJ^JaJ(h^h<n5B*CJOJQJ^Jph " P`r`rNrBFLF==== $$Ifa$$Ifkdp$$IfTl,r W#%(6G!gXgXgoG t6644 lBa]p2ytH?TFH LC:::: $$Ifa$ $IfgdYDkdq$$IfTl,r W#%(6G!gXgXgoG t6644 lBa]p2ytH?T  xL94+ $IfgdI/gdl! 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$$Ifa$gd3 $Ifgd3$[$\$a$gdt/f$a$gdt/f " -DM fffgdt/fgd~B>??a?m??????@ @@@4@@@@@ AAAA$A*AAAAATB`BdBfBʹ|j|jjRjj/h~Bht/f5>*B*CJOJQJ^JaJph#ht/fB*CJOJQJ^JaJph#hH?B*CJOJQJ^JaJph#ht/fB*CJOJQJ^JaJphht/fCJaJ!hH?5B*OJQJ\^Jph!ht/f5B*OJQJ\^Jph!hy:5B*OJQJ\^Jph ht/f5>*CJOJQJ^JaJ%ht/fht/fB*OJQJ^JaJph ???( $Ifgd3kd$$IfT;r!i#%(6G !GXGXGXG  t2662 24Bap2yt3T?@@ @@ $$Ifa$gd3@@@@4+ $$Ifa$gd3 $Ifgd3kdI$$IfTXr!i#%(6G !cccG  t662 24Bap2ytT@@@@@(kdf$$IfT,r!i#%(6G !cccG  t662 24Bap2ytT $$Ifa$gd3@ AAAAA $$Ifa$gd3 $Ifgd3AAAAAAI@444 $$Ifa$gd3 $Ifgd3kd$$IfT,r!i#%(6G !cccG t662 24Bap2yt3TAAATB( $Ifgd>kd$$IfT,r!i#%(6G !cccG  t662 24Bap2ytT $$Ifa$gd3TBXB\B`BdB $$Ifa$gd3dBfB"C&C4+ $$Ifa$gd3 $IfgdH?kd$$IfT;r!i#%(6G !cccG  t662 24Bap2ytTfBBBCCC C"C.C2C4CCCCCDDDDDDDDDE$E(E*EfEEEEEEFG"G.G2G4GZGGGGG"H.H2H4H핪#h>B*CJOJQJ^JaJph)ht/f5B*CJOJQJ\^JaJph,ht/f5>*B*CJOJQJ\^JaJphht/fCJaJ#ht/fB*CJOJQJ^JaJph#hH?B*CJOJQJ^JaJph#ht/fB*CJOJQJ^JaJph0&C*C.C2C4C(kd$$IfT,r!i#%(6G !cccG  t662 24Bap2ytT $$Ifa$gd34CCCCCC $$Ifa$gd3 $Ifgd3CCDD4+ $$Ifa$gd3 $Ifgd3kd=$$IfT;r!i#%(6G !cccG  t662 24Bap2ytTDDDDD(kd$$IfT,r!i#%(6G !cccG  t662 24Bap2ytT $$Ifa$gd3DEE E$E(E $$Ifa$gd3 $Ifgd3(E*EEE4+ $$Ifa$gd3 $Ifgd3kd٧$$IfT,r!i#%(6G !cccG  t662 24Bap2ytTEEEEE(kd $$IfT,r!i#%(6G !cccG  t662 24Bap2ytT $$Ifa$gd3E"G&G*G.G2G $$Ifa$gd3 $Ifgd32G4G"H&H4+ $$Ifa$gd3 $Ifgd>kdu$$IfTXr!i#%(6G !cccG  t662 24Bap2ytT&H*H.H2H4HH=4 $Ifgd3kd$$IfTXr!i#%(6G !cccG t662 24Bap2yt3T $$Ifa$gd34H>HHHHHHHHJ J JJJJ(JJJJJJJKKKKKLJLNt۷ۯ۷ۯ۷ۯ۷ۯudu۷ۯ۷!hH?5B*OJQJ\^Jph!ht/f5B*OJQJ\^JphU(h~Bht/f5B*CJOJQJ^Jph"hcW5B*CJOJQJ^Jphht/fCJaJ#ht/fB*CJOJQJ^JaJph#h[iB*CJOJQJ^JaJph#ht/fB*CJOJQJ^JaJph#h5MB*CJOJQJ^JaJph'HHHHH $$Ifa$gd3HH JJ4+ $$Ifa$gd3 $Ifgd3kd$$IfT,r!i#%(6G !cccG  t662 24Bap2ytTJJJJJJ=4 $Ifgd3kd.$$IfTXr!i#%(6G !cccG t662 24Bap2yt3T $$Ifa$gd3JJJJJ $$Ifa$gd3JJKK4+ $$Ifa$gd3 $Ifgd3kdY$$IfT,r!i#%(6G !cccG  t662 24Bap2ytTKKKKK(kd$$IfTXr!i#%(6G !cccG  t662 24Bap2ytT $$Ifa$gd3KKKL L $$Ifa$gd3 $Ifgd3 " -DM fffgdcW " gdcWYesNoN/ANotes/Supporting EvidenceHas the Data Safety Monitoring Plan (DSMP) been implemented as described in the protocol?oooHave reports been submitted in a timely manner?oooIs there a Data Safety Monitoring Board for this study?ooo>> Has the DSMB operated in accordance with the IRB approved protocol?ooo>> Are all DSMB reports or indication of DSMB review and recommendations on file?ooo>> Have all DSMB reports been submitted to the IRB?ooo EXTERNAL SITE MONITORING YesNoN/ANotes/Supporting EvidenceIs the study site monitored by an external site?oooIf yes, is there a monitoring log?oooIf yes, are copies of site visit (external) monitoring reports on file?oooIf yes, do monitoring reports include Site Initiation report/visit documentation?oooIf yes, do monitoring reports include study close-out report/visit documentation?oooIf yes, were reports submitted to the IRB in required timeline?ooo REPORTING When completing this portion of the assessment, please refer to the SLU definitions for reportable events in the HYPERLINK "https://www.slu.edu/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/guidelines_reportable_events.doc"SLU IRB Reporting Guidelines YesNoN/ANotes/Supporting EvidenceIs there a process in place for handling protocol deviations, violations, etc.?oooIs there a process in place to capture and document any AEs or unanticipated events?oooAdverse Events / SAEsYesNoN/ANotes/Supporting EvidenceHave all AE's been documented and classified by approved study personnel?oooWere sponsors and/or Federal agencies (such as the FDA if the investigator is the IND or IDE holder) notified of AEs according to their requirements?oooAre AE's being reported/provided to monitors/data safety boards as required by the protocol?oooWere AE's classified as related SAE's reported to the SLU IRB in accordance with required timelines?oooWere SAE's assessed as potential unanticipated problems?oooProtocol Violations (PVs) / DeviationsYesNoN/ANotes/Supporting EvidenceWere intentional protocol deviations approved by the IRB (and sponsor if applicable) prior to implementing them? (common examples include enrollment exceptions, planned missed visits, consent process deviations, immediate implementation of additional safety precautions not yet in the approved protocol)oooIf urgent protocol deviations were acknowledged by the IRB via email, were they followed up by submission of a report form?oooIf protocol deviations were not pre-approved by the IRB, were they reported as protocol violations?oooWere unintentional variations from the approved protocol assessed as potential reportable PVs (and is the assessment documented in the research record)?oooWere PVs that placed participants or others at greater risk of harm than if the protocol was followed as intended reported to the IRB in accordance with reporting timelines?oooWere corrective action plans noted in the PV report implemented by the study team?oooIf the event resulted in the requirement to re-consent, was re-consent obtained?ooo REGULATORY DOCUMENTATION FOR INVESTIGATIONAL PRODUCTS Investigators conducting studies under INDs or IDEs are required to maintain additional regulatory documentation. The extent of this additional regulatory documentation depends on whether you are a Clinical Investigator or a Sponsor-Investigator. A Clinical Investigator is an Investigator conducting research under a FDA regulated trial. A Sponsor-Investigator means the Investigator holds the IND and he/she assumes the responsibility of both an investigator AND a sponsor. YesNoN/ANotes/Supporting EvidenceFOR CLINICAL INVESTIGATORS AND SPONSOR INVESTIGATORSFor IND studies, is there a signed FDA 1572 on file?oooFor IDE studies, is an Investigator Statement on file?oooIs a Financial Disclosure form or a memo disclosing any financial conflicts/interests on file for each investigator listed on the 1572 or in the Investigator Statement?oooIs a valid licensure on file for each investigator/staff member listed on the 1572 or in the Investigator Statement?oooAre all correspondences to and from the sponsor on file?oooIs there a copy of the Investigator Brochure or Device Manual on file?oooIf the product is already marketed, is there a package insert/product information on file? oooFOR SPONSOR INVESTIGATORS ONLYIs the PI a sponsor-investigator (i.e. IND/IDE holder)?oooIf yes, is the following on file:ooo Original IND/IDE application to the FDAooo FDA letter of no objectionooo Amendments to the IND/IDEooo Annual reports to the IND/IDE ooo Safety reportsooo General correspondence with the FDAooo Are all relevant communications (e.g. meeting notes, letters and emails) with study sponsor on file?oooFor NIH funded studies, are the NIH grant and annual progress reports on file?oooFor IND studies, is there a FDA 1571 on file to accompany all of the above FDA correspondence?oooFor IND studies, note who is listed as the monitor in section 14 of the FDA form 1571. 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