PI Self-Assessment
Information about the IRB’s PI Self-Assessment (PISA)
This program is designed to help you meet your compliance assessment responsibility as the Principal Investigator. The
Office of the IRB records indicate that you are a Principal Investigator on at least one active human subject research
study. If this is incorrect, please contact the OIRB PI Self-Assessment manager at (210) 567-8250.
Timing of the Assessment
You are receiving this assessment a few weeks before a progress report is due to the OIRB. We want you to use the
study that is due for continuing review as the focus of this assessment. If you have more than one study scheduled for
continuing review in the next month, select one of them to perform the assessment.
Educational Nature of the Assessment
The PISA is primarily designed to inform you of specific regulatory requirements using a practical example from your own
records. Since you will be reviewing your specific-study records, the assessment should also prove helpful in completing
the upcoming IRB progress report. Please use the lessons learned from this assessment to all your human research
protocols.
Information about this form
This assessment contains 27-61 questions. The number of questions you answer depends on the complexity of your
study. It should take less than one hour to complete. You can save your responses and come back to complete the
assessment at a later time. However it must be completed (click complete at the end and submit) within two weeks from
the date you received your email notice.
The purpose of this self-assessment program is to improve the human research protections at the HSC. This goal of this
program is to educate investigators and research staff on federal and state regulations and HSC policies in the area of
research conduct and recordkeeping; assist investigators in assessing their own programs; and assist the OIRB / IRB in
identifying areas on which additional institutional educational programs may need to focus.
This self-assessment program will be conducted in a manner that protects anonymity to foster candid feedback without
the concern of punitive action. The e-mail invitations, unique identifiers, completed surveys and recommendations are
handled through the Department of Epidemiology and Biostatistics, who will have the only key for the PI unique identifiers.
The Office of the IRB (OIRB) and the Office of Clinical Research (OCR) will not link your answers back to you. When
answering the questions please do not include any research staff or department names, or any specifics that would make
your answers identifiable.
The OIRB Staff will review each de-identified assessment and make individual recommendations based on the
information received, while keeping your anonymity. The OIRB staff will only receive names of individuals who have not
completed the assessment at the end of each assessment period and will contact those individuals directly to discuss.
IRB Documentation
1. How do you store (file) the IRB approved protocol (original and each revised version)?
 Electronic
Great – you should continue keeping a record of the approved protocol in your study records.
 Paper
Great – you should continue keeping a record of the approved protocol in your study records.
 Hybrid (Electronic and Paper)
Great – you should continue keeping a record of the approved protocol in your study records.
 I don't have a file of all versions of the IRB approved protocol
You should keep a copy of the original and each revised version in your study records.
Corrective Action: This is easy to correct. The Office of the IRB [OIRB] sends electronic copies of the approved protocol
as an attachment to the approval notice (initial approval and approval of amendments). If you are unable to locate these
files you may contact the OIRB to obtain a copy from the IRB records for your study ((210) 567-8250). For guidance on
regulatory file maintenance, including IRB documentation and all other study documentation refer to information below, or
contact the Office of Clinical Research (OCR) for a consultation.
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Study documentation and Data Management: Appendix A, Essential
Documents for the Regulatory Binder; and
ICH GCP: Chapter E6, § 8
2. Do you have the initial IRB Notice of Approval on file for this protocol?
 Yes
Great – the initial notice should always be kept in your study files.
 No
The initial notice from the IRB that your research was approved should always be kept in your study files.
Corrective Action: Obtain/retrieve the Initial Approval letter issued by the IRB, or request a duplicate from the OIRB by
calling (210) 567-8250.
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Study documentation and Data Management: Appendix A, Essential
Documents for the Regulatory Binder; and
ICH GCP: Chapter E6, § 8
3. Do you have the IRB Re-Approval Notice for Continuing Review (Progress Reports) on file for each progress
report you submitted for this protocol?
 Yes
Great – you should continue keeping these notices in your study records
 No
The notice from the IRB that your research was re-approved should always be kept in your study files.
Corrective Action: Obtain/retrieve a copy of the IRB Continuing Review (CR) Approval letter and any other CR materials
submitted to the IRB that may be missing from your records. You may request a duplicate approval letter from the OIRB
by calling (210) 567-8250, if needed, and place it in your records.
 N/A – A progress report has never been submitted for this study.
Where to find more information
IRB Policy: Continuation Review Policy and Procedure
OCR Policies: Principal Investigator Responsibilities; Study documentation and Data Management: Appendix A, Essential
Documents for the Regulatory Binder; and
ICH GCP: Chapter E6, § 8
4. Do you have the IRB Notice of Approval for Modifications (Amendments) on file for each approved amendment for
this protocol?
 Yes
Great – you should continue keeping these notices in your study records.
 No
The notice from the IRB that your amendment/modification was approved should always be kept in your study files.
Corrective Action: Obtain/retrieve a copy of the IRB Amendment Approval letter(s) and any other Amendment materials
submitted to the IRB that may be missing from your records. You may request a duplicate approval letter (and approved
documents) from the OIRB by calling (210)567-8250, if needed, and place it in your records.
 N/A – Study has never been modified since it was initially approved.
Where to find more information
IRB Policy: Modification and Amendments Policy and Procedure
OCR Policies: Principal Investigator Responsibilities; Study documentation and Data Management: Appendix A, Essential
Documents for the Regulatory Binder; and
ICH GCP: Chapter E6, § 8
5. Do you have all Notices of IRB determinations for all other IRB Review Actions (such as UPIRSO,
Noncompliance, etc.) on file for this protocol?
 Yes
Great Job!
 No
Corrective Action: Obtain/retrieve a copy of the IRB Notice of Approval letter(s) and any other materials submitted to the
IRB that may be missing from your records. You may request a duplicate approval letter from the OIRB by calling
210)567-8250, if needed, and place it in your records.
 N/A - We have never submitted a UPIRSO or Noncompliance report for this study.
Where to find more information
IRB Policies: UPIRSO Policy and Procedure; Noncompliance Policy and Procedure; Suspension or Termination of
Research Policy and Procedure
OCR Policies: Principal Investigator Responsibilities; Study documentation and Data Management: Appendix A, Essential
Documents for the Regulatory Binder; and
ICH GCP: Chapter E6, § 8
6. Do you keep a binder/folder of all regulatory documents (e.g. IRB Correspondence, approval letters from other
sites, CVs, DSMB reports, clinical lab documents, site SOPs, etc.)?
 Yes
Great Job!
 No
Corrective Action: Obtain/retrieve any regulatory documents that may be missing from your records. Develop in writing, a
system to consistently collect and maintain regulatory documents for your study. You may also contact the OIRB for
comparison to the IRB’s records at (210)567-8250.
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Study documentation and Data Management: Appendix A, Essential
Documents for the Regulatory Binder; and
ICH GCP: Chapter E6, § 8
Study Conduct
7. Was there any lapse in IRB approval for this study?
 Yes
Corrective Action: To help make the Continuing Review (CR) process more efficient and avoid lapses in IRB approval, for
future CR requests, submit all requested CR materials in a timely manner to the OIRB. Be aware that delays in
responding to IRB requests for information may result in a lapse in IRB approval.
 No – Skip to 11
Great Job!
Where to find more information
IRB Policy: Continuation Review Policy and Procedure
8. Was any subject enrolled (or reenrolled) during the lapse period?
 Yes
Corrective Action: If you haven’t already done so, report this issue to the IRB as a possible noncompliance. All research
activities (including subject enrollment and data analysis of identifiable data) must stop once the study’s IRB approval has
expired. Note: the expiration date of the study’s IRB approval is the first day of the lapse (when reseach activities must
stop). For example: if the study expiration date is January 4, 2013, the last day research activities may occur is January
3, 2013.
 No
Great Job!
Where to find more information
IRB Policy: Continuation Review Policy and Procedure
9. Did any research activities involving subjects occur during the lapse period?
 Yes
Corrective Action: If you haven’t already done so, report this issue to the IRB as a possible noncompliance. All research
activities (including subject enrollment and data analysis of identifiable data) must stop once the study’s IRB approval has
expired. Note: the expiration date of the study’s IRB approval is the first day of the lapse. For example: if the study
expiration date is January 4, 2013, the last day research activities may occur is January 3, 2013.
 No
Great Job!
Where to find more information
IRB Policy: Continuation Review Policy and Procedure
10. Was the IRB notified of the research activity that occurred during the lapse?
 Yes
Great Job!
 No
Corrective Action: Report to the IRB as a possible noncompliance.
Where to find more information
IRB Policy: Continuation Review Policy and Procedure
11. Do you have a mechanism for tracking enrollment to ensure you do not exceed the total number approved by the
IRB?
 Yes
Great Job!
 No
Corrective Action: Develop a tracking log. Without such a tool, you risk being in noncompliance for exceeding the total
number of approved subjects in your research. You may contact the OIRB at (210)567-8250 for assistance.
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Study documentation and Data Management: Appendix A, Essential
Documents for the Regulatory Binder; and
ICH GCP: Chapter E6, § 8
12. Were all study procedures conducted as described in the IRB approved protocol?
 Yes
Great Job!
 No
Corrective Action: Depending on the deviation(s), you may need to submit as possible noncompliance to the IRB. More
information on Noncompliance can be found in the Noncompliance Policy and Procedure as well as the Prompt Report
Form.
Where to find more information
IRB Policy: Noncompliance Policy and Procedure
OCR Policy: Principal Investigator Responsibilities
13. Were all changes in the protocol reported to the IRB?
 Yes
Great Job!
 No
Corrective Action: Submit as possible noncompliance to the IRB (unless the change was made to eliminate an immediate
hazard to subjects in which case, submit as a possible UPIRSO), and an Amendment (modification) Request to change
the protocol, if these changes are to be continued. (IRB Report forms are available at
http://research.uthscsa.edu/irb/study.shtml)
Where to find more information
IRB Policies: Modification and Amendments Policy and Procedure; Noncompliance Policy and Procedure; Unanticipated
Problems Involving Risk to Subjects or Others (UPIRSO) And Unanticipated Adverse Device Effects (UADE) Policy and
Procedure
OCR Policy: Principal Investigator Responsibilities
14. Do you keep a study file for each subject?
 Yes
Great Job!
No
Corrective Action: Obtain/retrieve documents containing research related information on individual subjects (signed
consent forms, case report forms, research notes, etc.) and organize them in the corresponding subjects’ files. For
consultation, contact OCR by phone at 210-567-8555 or OCRMail@uthscsa.edu
 N/A - Study does not involve interacting/intervening with subjects (secondary data collection only)
Where to find more information
IRB Policy: Noncompliance Policy and Procedure
OCR Policies: Principal Investigator Responsibilities; Study documentation and Data Management: Appendix A, Essential
Documents for the Regulatory Binder; and
ICH GCP: Chapter E6, § 1.51, 1.52, 2.11, 2.12, 4.9
Staff
15. Do all of the members of the research staff who are engaged in human subjects research have an institutionally
approved research Scope of Practice?
 Yes
Great Job! Make sure the each person’s Scope of Practice is kept up-to-date.
 No
Corrective Action: Obtain Research Scope of Practice forms on OCR website to complete and submit through OCR (or
other appropriate institutional office) for approval.
 I don't know what a Scope of Practice is
Corrective Action: Review the references below and obtain Research Scope of Practice forms on OCR website to
complete and submit through OCR (or other appropriate institutional office) for approval, if necessary.
 N/A - Scope of Practice is not required by OCR for staff listed on this protocol
Where to find more information
HOP Policy: Research Scope of Practice for Study Personnel
OCR Policies: Principal Investigator Responsibilities; Training, Qualification, and Delegation of Authority; and Study
Documentation and Data Management
16. Do you have an study staff list (Form B-2, Step 2-Inst or Inst M) on file?
 Yes
Great Job!
 No
Corrective Action: Obtain/retrieve the approved study staff list that may be missing from your records (you may contact
the OIRB to obtain a copy at (210) 567-8250).
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Training, Qualification, and Delegation of Authority; Study
Documentation and Data Management; and Institutional Review
17. Do all the study staff have current UTHSCSA Human Research Training?
 Yes
Great Job!
 No
Corrective Action: Submit as possible noncompliance to the IRB if any of these individuals are “engaged in research” (i.e.,
interacting or intervening with research subjects and/or obtaining or using private identifiable information). If you (or your
study personnel) need to complete this training, and you need more information, contact the OCR by phone at 210-5678555 or OCRMail@uthscsa.edu, or visit the OCR web site at http://research.uthscsa.edu/ocr/training.shtml.
 N/A - IRB accepted alternate source of training
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Training, Qualification, and Delegation of Authority; Study
Documentation and Data Management ; Institutional Review and Human Subjects Protection and Ethics Education
18. If there have been changes to study staff since the protocol was initially approved, was an amendment submitted
for IRB and/or OCR approval of these changes?
 Yes
Great Job!
 No
Corrective Action: Submit as possible noncompliance to the IRB, and an Amendment (modification) Request to change
the protocol. Anytime study staff changes, record start and stop dates in the Delegation of Authority log, obtain signatures
for new staff members, and ensure appropriate training before adding staff via an amended Form B-2, Step 2-Inst or Inst
M with IRB and/or OCR.
 N/A - There have been no staff changes to this protocol
Where to find more information
IRB Policy: Modification and Amendments Policy and Procedure; Noncompliance Policy and Procedure
OCR Policies: Principal Investigator Responsibilities; Training, Qualification, and Delegation of Authority; Study
Documentation and Data Management ; Institutional Review; Human Subjects Protection and Ethics Education
19. Do you have a staff orientation or other method of training on study-specific procedures?
 Yes
Great Job!
 No
Corrective Action: Develop a process for ensuring adequate training and education for study staff on each research
protocol. Review OCR Policy 1.2.1 Training, Qualification, and Delegation of Authority, and contact the OCR by phone at
210-567-8555 or OCRMail@uthscsa.edu.
 N/A - No other study staff besides PI
Where to find more information
HOP Policy: Research Scope of Practice for Study Personnel
OCR Policies: Principal Investigator Responsibilities; Training, Qualification, and Delegation of Authority; Study
Documentation and Data Management
20. Do you have documentation of training for all staff on file?
 Yes
Great Job!
 No
Corrective Action: Develop a method for documenting the training of study staff for each research protocol. Review OCR
Policy 1.2.1 Training, Qualification, and Delegation of Authority, and contact the OCR by phone at 210-567-8555 or
OCRMail@uthscsa.edu.
 N/A - No other study staff besides PI
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Training, Qualification, and Delegation of Authority; Study
Documentation and Data Management
21. If there have there been any changes to your personal financial situation that would require updating your Conflict
of Interest form, did you submit this change to the IRB?
 Yes
Great Job!
 No
Corrective Action: Submit a request to the Office of the Vice President for Research to update your information in
iDisclose and notify the IRB of the change. The Principal Investigator (PI) is responsible for informing the IRB in writing of
any potential conflict of interest related to the research activities. The IRB will make a determination if disclosure to
subjects involved in the research is warranted via the informed consent document.
 I don't know what a conflict of interest is
Corrective Action: Review the information in the references listed below. You may also need to contact the Office of the
Vice President for Research to complete or update your information in iDisclose.
 N/A - There have been no changes relative to possible financial conflict of interest for this study
Great Job!
Where to find more information
IRB Glossary of Terms: Conflict of Interest
HOP Policies: Conflict of Interest Committee; Conflicts of Interest in Scholarly, Research, and Clinical Activity; Conflict of
Commitment; Institutional Conflict of Interest Policy
OCR Policy: Principal Investigator Responsibilities
Recruitment
22. Were all methods of recruitment (media, chart review, etc.) including changes approved by the IRB?
 Yes
Great Job!
 No
Corrective Action: Submit as possible noncompliance to the IRB. Be familiar with the procedures for identifying potential
subjects as approved in your protocol and follow them accordingly. If changes need to be made to the procedure(s)
approved by the IRB for identifying potential subjects, submit a modification request (Amendment Form) with a description
of the changes requested. Forms are available at http://research.uthscsa.edu/irb/study.shtml
 N/A – This study does not involve recruitment Skip to 25
Where to find more information
IRB Policies: Identification and Recruitment of Participants Policy and Procedure; Modification and Amendments Policy
and Procedure;
OCR Policy: Principal Investigator Responsibilities
23. Are all those who are making initial contact for recruitment approved to do so? (e.g. IRB approved the
‘recruitment’ role on Step 2-Inst and personnel assigned to the role are on the approved Inst M). Note that study
roles and personnel will be combined on the Form B-2.
 Yes
Great Job!
 No
Corrective Action: Submit as possible noncompliance to the IRB. Be familiar with the staff approved for making initial
contact with potential subjects. If changes need to be made to the procedure(s) approved by the IRB and/or OCR for
identifying potential subjects, submit a modification request (Amendment Form) with a description of the changes
requested. Forms are available at http://research.uthscsa.edu/irb/study.shtml
Where to find more information
IRB Policy: Identification and Recruitment of Participants Policy and Procedure
HOP Policy: Research Scope of Practice for Study Personnel
OCR Policies: Principal Investigator Responsibilities; Training, Qualification, and Delegation of Authority; Study
Documentation and Data Management; Institutional Review
24. Are all approved recruitment materials (flyers, telephone scripts, radio/television scripts, etc.) both original &
revised, on file?
 Yes
Great Job!
 No
Corrective Action: Obtain/retrieve recruitment materials/tools missing from your records, and their corresponding IRB
approval letters. You may request a duplicate from the Office of the IRB at (210)567-8250.
Where to find more information
IRB Policy: Modification and Amendments Policy and Procedure;
OCR Policy: Principal Investigator Responsibilities;
Informed Consent Process
25. Does your study involve obtaining informed consent (either verbal or written) for any subjects?
 Yes
 No - Skip to 29
Where to find more information
IRB Policies: Informed Consent Policy and Procedure; Informed Consent Process; Written Documentation Policy
FDA: 21 CFR § 50.20 General requirements of informed consent; § 50.27 Documentation of informed consent
DHHS: 45 CFR § 46.116 General requirements of informed consent; § 46.117 Documentation of informed consent
Informed Consent Process - Continued
26. Did the IRB waive the requirement to obtain a signed consent form for any subjects?
 No
 Yes, please explain: - then skip to 29
[open ended text field]
Where to find more information
IRB Policies: Informed Consent Policy and Procedure; Informed Consent Process; Written Documentation Policy
27. Were all versions of each consent form approved by the IRB? This includes any revised consent forms as well as
translations of English consent forms. If you told the IRB you would translate your English consent form
immediately after IRB approval, have you submitted the translated version to the IRB for approval?
 Yes
Great Job!
 No
Corrective Action: Submit the revised and/or translated consent forms to the IRB for approval. Develop a system to
ensure that revised and translated consent forms are submitted to the IRB for approval and all approved versions are
maintained in your research records for no less than six years after IRB approval has ended. Your unit should also have
procedures in place describing how study personnel will be trained/educated on the measures established to maintain and
use the approved consent forms in your research. Although submitting your training plans to the IRB is not required at this
time, be prepared to present them to the IRB in the future.
If any of the unapproved consent forms were used in the research, you should also submit as possible noncompliance to
the IRB.
Where to find more information
IRB Policies: Informed Consent Policy and Procedure; Written Documentation Policy
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
28. Did all consent forms used in this study contain the most current IRB approval stamp?
 Yes
Great Job!
 No
Corrective Action: Submit as possible noncompliance to the IRB. Obtain/retrieve a copy for your records of each version
of each stamped consent document approved throughout the “life” of the protocol. You may contact the Office of the IRB
at (210)567-8250 for comparison with their records or assistance. Develop a system to ensure that all original stamped
IRB approved consent forms are used when enrolling subjects and maintained in your research records for no less than
six years after IRB approval has ended. Your unit should also have procedures in place describing how study personnel
will be trained/educated on the measures established to maintain original consent forms in your research records.
Although submitting your training plans to the IRB is not required at this time, be prepared to present them to the IRB in
the future.
Where to find more information
IRB Policies: Informed Consent Policy and Procedure; Written Documentation Policy
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
Review of Records
For this next section randomly select three (3) subject files or if you have enrolled less than four (4) include all subject
files. (Ideally one in the beginning stage, one at mid-stage, and one near completion of the study). If you have enrolled
less than four (4) subjects, review all subject files. Please complete the following questions relating to any of these subject
files:
29. Is there a data record and/or source document(s)?
 Yes – Go to Next
 No – Skip to Question 31
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
30. Were all protocol required data (inclusion/exclusion criteria met, outcome measurement data, etc.) captured in the
data record/source (original) documents for each subject?
 Yes
Great Job!
 No
Corrective Action: Report this as a deviation on your next Progress Report. If this has happened continuously, you should
consider submitting as possible noncompliance to the IRB containing an explanation about what transpired, why it
occurred and describe what measures have been/will be taken to ensure in the future that required data is collected per
the protocol. If the protocol no longer requires this information to be obtained, submit an amendment to the IRB to modify
the outcomes and measures accordingly.
Where to find more information
IRB Policies: Decision Tree – Evaluating Departures; Noncompliance Policy and Procedure; Modification and
Amendments Policy and Procedure
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
31. Did the person who actually obtained informed consent (conducted the consent interview) sign the form?
 Yes
Great Job!
 No
Corrective Action: Submit as possible noncompliance to the IRB containing an explanation about what transpired, and
confirmation that the individual(s) providing information to the subject had the authority and expertise to do so, and
describe what measures will be taken to ensure in the future that informed consent will be appropriately documented.
 N/A - This study does not involve the use of consent forms – Skip to 39
Where to find more information
IRB Policies: Informed Consent Policy and Procedure; Noncompliance Policy and Procedure;
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
32. Were all fields in the signature block completed (names & signatures of the subject, the witness, the study
personnel, and the date the form was signed)?
 Yes
Great Job!
 No
Corrective Action: Submit as possible noncompliance to the IRB containing an explanation about what transpired, and
describe what measures will be taken to ensure in the future that informed consent will be appropriately documented.
Where to find more information
IRB Policies: Informed Consent Policy and Procedure; Written Documentation Policy; Noncompliance Policy and
Procedure;
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
33. At the time of consent, was the person who obtained informed consent approved to do so? (e.g. IRB approved the
‘obtain informed consent’ role on Step 2-Inst and personnel assigned to the role are on the approved Inst M).
Note that study roles and personnel will be combined on the Form B-2.
 Yes
Great Job!
 No
Corrective Action: Submit as possible noncompliance to the IRB. Be familiar with the staff approved for obtaining informed
consent. If changes need to be made to the procedure(s) approved by the IRB and/or OCR for identifying potential
subjects, submit a modification request (Amendment Form) with a description of the changes requested. Forms are
available at http://research.uthscsa.edu/irb/study.shtml.
Where to find more information
IRB Policies: Informed Consent Policy and Procedure; Noncompliance Policy and Procedure;
HOP Policy: Research Scope of Practice for Study Personnel
OCR Policies: Principal Investigator Responsibilities; Training, Qualification, and Delegation of Authority; Study
Documentation and Data Management; Institutional Review
34. Did the subject sign the consent form prior to participation in any research activities?
 Yes
Great Job!
 No
Corrective Action: Submit as possible noncompliance to the IRB containing an explanation of what transpired, and details
about participation of any subject in your study for whom you do not have a signature (or their legally authorized
representative’s signature) on a consent document. Explain why a signature was not obtained, why the subject was
allowed to participate in the research without providing the signature, what research procedures the individual completed,
and if applicable, the outcome of the individual’s participation. Describe what measures will be taken in the future to
ensure informed consent is appropriately obtained and documented prior to any research procedures taking place. Your
unit should also have procedures in place describing how study personnel will be trained/educated on the procedures for
obtaining informed consent prior to implementing research related procedures/interventions with a subject. Include in your
report to the IRB the procedures established for training study personnel.
 N/A – Subject was unable to sign consent (due to age or ability) and LAR signed for him/her.
Where to find more information
IRB Policies: Informed Consent Policy and Procedure; Noncompliance Policy and Procedure;
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
35. If subject is a minor, did a parent or LAR sign the consent form?
 Yes
Great Job!
 No
Corrective Action: Submit as possible noncompliance to the IRB containing an explanation of what transpired, and why a
parent/guardian’s signature was not obtained. Clarify whether the minor participated in the research, if so, what research
procedures occurred and describe what measures will be taken in the future to ensure that appropriate signatures will be
obtained when enrolling minors.
 N/A – Study does not involve minor subjects
Where to find more information
IRB Policies: Informed Consent Policy and Procedure; Informed Consent Process; Written Documentation Policy;
Noncompliance Policy and Procedure;
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
36. If your consent forms have two signature sections, has each subject signed both sections of the IRB-approved
(stamped) combined consent form?
 Yes
Great Job!
 No
Corrective Action: Become knowledgeable about HIPAA and it’s applicability to your research. You may visit OIRB’s web
site at: http://research.uthscsa.edu/irb/hipaa.shtml for additional information, or contact the OIRB Office at (210)567-8250,
for assistance in determining whether you need to take further action to be in compliance with HIPAA.
 N/A – Study does not involve the use of PHI.
Where to find more information
IRB Policies: Informed Consent Policy and Procedure; HIPAA in Research Policy and Procedure
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
37. Was the subject (or parent or guardian) given a copy of the consent form?
 Yes
Great Job!
 No
Corrective Action: Submit as possible noncompliance to the IRB if the subject (parent or guardian) was not provided with
a copy of the consent form. The consent form contains important information to which a subject may need to refer during
the course of the research (i.e., PI contact information, study procedures, withdrawal information, risks/discomforts,
etc…). Providing the subject with a copy of the signed consent form gives them the opportunity to review key components
of the research at a later date, and gives the subject appropriate written information to support their ability to give fully
informed consent.
Where to find more information
IRB Policy: Informed Consent Policy and Procedure
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
38. Is documentation about how consent was obtained and that the Subject received a copy of the consent form on
file?
 Yes
Great Job!
 No
Corrective Action: Documentation indicating how the consent interview was conducted, what information was provided to
the subject, and that the subject received a copy of the signed consent/assent form is a means to verify that subjects have
been given appropriate information about the study and supports their ability to give fully informed consent. Develop a
plan to document the consent process for each subject enrolled in your study. This documentation needs to be recorded
whether the subject provides a signed consent or a verbal consent.
Where to find more information
IRB Policies: Informed Consent Policy and Procedure; Written Documentation Policy
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
Problem Reporting
39. Were the internal or external adverse events (AE) that occurred in your study reviewed by the PI?
 Yes
Great Job!
 No
Corrective Action: Compare case records and source documentation for all subjects to the AE log to ensure all AEs are
captured. Report to sponsor per protocol. If the frequency of similar AEs accumulated exceeds that which was proposed
in the protocol and approved IRB submission, report to IRB per policy.
 N/A – No AEs occurred.
Where to find more information
IRB Glossary of Terms: Adverse Event; Unanticipated Adverse Device Effect (UADE); UPIRSO; Unexpected Adverse
Event
IRB Policy: Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO) And Unanticipated Adverse Device
Effects (UADE) Policy and Procedure
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
FDA: 21 CFR 312 Investigational New Drug Application; 21 CFR 812 Investigational Device Exemptions
40. Were other problems that occurred in your study (that were not adverse events) reviewed by the PI?
 Yes
Great Job!
 No
Corrective Action: Compare case records and source documentation for all subjects to the AE/UP Tracking log to ensure
all Unanticipated Problems (Ups) are captured. Report to sponsor per protocol. If the Problems are unanticipated,
related to the research and suggest that the research places the subjects or others at a greater risk of harm, report to
IRB per UPIRSO policy.
 N/A – no other problems (Non-AE) occurred
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
FDA: 21 CFR 312 Investigational New Drug Application; 21 CFR 812 Investigational Device Exemptions
41. Describe your plan to track all problems (AE and non-AE) and to document your review of problems:
(open ended text field)
You will receive feedback after the OIRB QA/QI staff have reviewed your response.
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
42. Were all the UPIRSOs promptly reported to the IRB?
 Yes – Skip to 44
Great Job!
 No
Corrective Action: Submit a Prompt Report (possible UPIRSO and noncompliance) to the IRB containing an explanation
about what transpired, and describe what measures will be taken to ensure in the future that unanticipated adverse events
there were at least probably related and were either serious or suggest a greater risk than was identified will be reported
promptly to the IRB.
 N/A – There were no unanticipated problems which occurred that were probably related and suggested a greater
risk than previously known – Skip to 44
 I don't know what a UPIRSO is.
Corrective Action: Review the references listed below. Then re-evaluate any problems that occurred. If you determine
the events or problems meet the UPIRSO criteria, submit a Prompt Report to the IRB. You may also contact the OIRB for
additional guidance at (210)567-8250.
Where to find more information
IRB Glossary of Terms: Adverse Event; Unanticipated Adverse Device Effect (UADE); UPIRSO; Unexpected Adverse
Event
IRB Policies: Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO) And Unanticipated Adverse Device
Effects (UADE) Policy and Procedure; Noncompliance Policy and Procedure;
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
FDA: 21 CFR 312 Investigational New Drug Application; 21 CFR 812 Investigational Device Exemptions
43. Indicate the reason for not reporting.
 Omission
Corrective Action: Submit a Prompt Report (possible UPIRSO and noncompliance) to the IRB containing an explanation
about what transpired, and describe what measures will be taken to ensure in the future that unanticipated adverse events
there were at least probably related and were either serious or suggest a greater risk than was identified will be reported
promptly to the IRB.
 Expected AE mild to moderate.
Great Job!
 Unexpected AE mild.
Great Job!
 N/A – Did not require reporting because the problem did not meet criteria for prompt reporting.
Great Job!
 Other, please specify:
[open ended text field]
Where to find more information
IRB Glossary of Terms: Adverse Event; Unanticipated Adverse Device Effect (UADE); UPIRSO; Unexpected Adverse
Event
IRB Policies: Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO) And Unanticipated Adverse Device
Effects (UADE) Policy and Procedure; Noncompliance Policy and Procedure;
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
FDA: 21 CFR 312 Investigational New Drug Application; 21 CFR 812 Investigational Device Exemptions
FDA Regulatory Documentation
44. Does your study involve the use of Drugs or Devices?
 Yes
 No [Skip to End]
Where to find more information
IRB Glossary of Terms: Drug, Device
IRB Policies: Research Involving a Drug Policy and Procedure; Research Involving a Device Policy and Procedure
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
ICH GCP: Chapters 4-8 as applicable
FDA Regulatory Documentation - Continued
45. Are all versions of the package insert(s), Device Manual, or product information sheet(s) on file?
 Yes
Great job!
 No
Corrective Action: Retrieve or obtain all versions of the Investigator Brochure or Device Manual for your file records. If
applicable, include the package insert/product information in your records as well.
Where to find more information
IRB Policies: Research Involving a Drug Policy and Procedure; Research Involving a Device Policy and Procedure
OCR Policies: Principal Investigator Responsibilities; Storage and Control of Investigational Drugs and Devices For
Clinical Research (may apply even if drug/device is not focus of the study); Study Documentation and Data Management
ICH GCP: Chapter E6, § 4.6
46. Do you maintain a log of all drug/device shipping and receiving?
 Yes
Great job!
 No
Corrective Action: Develop a system and document standard operating procedures to record receiving and shipping of the
investigational product(s). Your unit should also have procedures in place describing how study personnel will be
trained/educated on the drug/device shipping and receiving guidelines. Submit an Amendment form along with both the
drug/device shipping and receiving guidelines and procedures for training study personnel to the IRB for review.
 N/A - Drug/device is located on site and does not require shipment
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Storage and Control of Investigational Drugs and Devices For
Clinical Research; Study Documentation and Data Management
ICH GCP: Chapter E6, § 4.6
47. Do you have an OCR approved site/SOP to store the drug/device(s) outside Hospital Pharmacy or Investigational
Drug Section of CTRC?
 Yes
Great job!
 No
Corrective Action: Develop or acquire guidelines appropriate for storage of the drug/device and submit through OCR for
review to yield an approved drug storage number required for completing IRB Form B (item 9) or Step 2 Inst (item 30).
Your unit should also have procedures in place describing how study personnel will be trained/educated on the
drug/device storage guidelines. Submit an Amendment form along with both the drug/device storage guidelines and
procedures for training study personnel to the IRB for review.
 Unsure
Corrective Action: Develop or acquire guidelines appropriate for storage of the drug/device and submit through OCR for
review to yield an approved drug storage number required for completing IRB Form B (item 9) or Step 2 Inst (item 30).
Your unit should also have procedures in place describing how study personnel will be trained/educated on the
drug/device storage guidelines. Submit an Amendment form along with both the drug/device storage guidelines and
procedures for training study personnel to the IRB for review.
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Storage and Control of Investigational Drugs and Devices For
Clinical Research; Study Documentation and Data Management
48. Is the drug/device(s) stored in the OCR approved location?
 Yes
Great job!
 No
Corrective Action: Develop or acquire guidelines appropriate for storage of the drug/device and submit through OCR for
review to yield an approved drug storage number required for completing IRB Form B (item 9) or Step 2 Inst (item 30).
Your unit should also have procedures in place describing how study personnel will be trained/educated on the
drug/device storage guidelines. Submit an Amendment form along with both the drug/device storage guidelines and
procedures for training study personnel to the IRB for review.
 Unsure
Corrective Action: Develop or acquire guidelines appropriate for storage of the drug/device and submit through OCR for
review to yield an approved drug storage number required for completing IRB Form B (item 9) or Step 2 Inst (item 30).
Your unit should also have procedures in place describing how study personnel will be trained/educated on the
drug/device storage guidelines. Submit an Amendment form along with both the drug/device storage guidelines and
procedures for training study personnel to the IRB for review.
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Storage and Control of Investigational Drugs and Devices For
Clinical Research; Study Documentation and Data Management
49. Is there a log for dispensing and retrieving the drug/device to and from the subject?
 Yes
Great job!
 No
Corrective Action: Develop or acquire guidelines appropriate for storage of the drug/device and submit through OCR for
review to yield an approved drug storage number required for completing IRB Form B (item 9) or Step 2 Inst (item 30).
Your unit should also have procedures in place describing how study personnel will be trained/educated on the
drug/device storage guidelines. Submit an Amendment form along with both the drug/device storage guidelines and
procedures for training study personnel to the IRB for review.
 N/A – This is a device study where we do not dispense the device
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Storage and Control of Investigational Drugs and Devices For
Clinical Research; Study Documentation and Data Management
FDA Regulated: Investigational Use
50. Does the study include Investigational use of Drugs or Devices?
 Yes
 No [Skip to End]
Where to find more information
IRB Glossary of Terms: Investigational Drug, Investigational Device
IRB Policies: Research Involving a Drug Policy and Procedure; Research Involving a Device Policy and Procedure
OCR Policies: Principal Investigator Responsibilities; Storage and Control of Investigational Drugs and Devices For
Clinical Research; Study Documentation and Data Management
FDA: 21 CFR 312 Investigational New Drug Application; 21 CFR 812 Investigational Device Exemptions
51. Are all versions of the Investigator's Brochure, package insert(s), Device Manual, or product information sheet(s)
on file?
 Yes
Great job!
 No
Corrective Action: Gather Investigator Brochure or manufacturer’s Device Manual and create a file contact the OCR by
phone at 210-567-8555 or OCRMail@uthscsa.edu for a consultation.
Where to find more information
IRB Policies: Research Involving a Drug Policy and Procedure; Research Involving a Device Policy and Procedure
OCR Policies: Principal Investigator Responsibilities; Storage and Control of Investigational Drugs and Devices For
Clinical Research; Study Documentation and Data Management
FDA: 21 CFR 312 Investigational New Drug Application; 21 CFR 812 Investigational Device Exemptions
ICH GCP: Chapter E6, § 4.6
52. Is a copy of the FDA required Clinical Investigator Financial Disclosure form on file for each investigator (IND,
device or biologic studies)?
 Yes
Great job!
 No
Corrective Action: Review HOP 10.1.6. Conflicts of Interest in Research and Disclosure and complete required Disclosure
Statement forms IRB Form X and Form FDA 3455.
Where to find more information
HOP Policy: Conflicts of Interest in Research and Disclosure
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
FDA: 21 CFR 54.4 (a) and (b) Financial Disclosure by Clinical Investigators; 21 CFR 312 Investigational New Drug
Application; 21 CFR 812 Investigational Device Exemptions
53. Do you have the Sponsor's signed FDA 1572 (IND study) or Investigator Agreement (device study) on file?
 Yes
Great job!
 No
Corrective Action: Obtain Form FDA 1572 or Investigator Agreement from sponsor, complete, sign and return to sponsor.
Keep study copy on file in study Regulatory Binder.
Where to find more information
FDA: 21 CFR 312 Investigational New Drug Application; 21 CFR 812 Investigational Device Exemptions; FDA Guidance
Frequently Asked Questions (Statement of Investigator – Form 1572)
54. For a study involving a drug, device or biologic, identify the “responsible party”, i.e., who is initiating the study –
regardless of fund source.
 Investigator
This answer indicates that you are conducting Investigator Initiated Research with or without IND or IDE.
 Sponsor
This answer indicates that you are NOT conducting Investigator Initiated Research with or without IND or IDE.
55. Are you the IND or IDE Sponsor or have you assumed the role of Sponsor?
 N/A – I am not a Sponsor-Investigator – skip to end
 I hold the IND or IDE (Sponsor-Investigator)
 I have assumed the role of the sponsor by initiating and conducting the research or by receiving delegated
sponsor responsibilities via the Clinical Trial Agreement (CTA) or Material Transfer Agreement (MTA), regardless
of funding source
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Sponsor Investigator
FDA: 21 CFR 312 Investigational New Drug Application; 21 CFR 812 Investigational Device Exemptions
56. Have you selected a study monitor qualified by education and experience? (not the same as a medical safety
monitor, DSMC, or DSMB)
 Yes
Great job!
 No
Corrective Action: As the responsible party initiating the research, you are required to select a monitor and document
study monitoring procedures, monitor findings, and file reports in the study files. Please contact OCR at 567-8555 or
OCRMail@uthscsa.edu for a consultation appointment.
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Sponsor Investigator
FDA: 21 CFR 312 Investigational New Drug Application; 21 CFR 812 Investigational Device Exemptions
ICH GCP: Chapter E6, § 5.18
57. Has the monitor been trained on the protocol?
 Yes
Great job!
 No
Corrective Action: As the responsible party initiating the research, you are required to select a monitor and train them on
the protocol; sponsors are required to document study monitoring procedures, collect monitor findings with any corrective
action plans, and file detailed reports in the study files. Please contact the OCR at 567-8555 or OCRMail@uthscsa.edu
for a consultation appointment.
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Sponsor Investigator
FDA: 21 CFR 312 Investigational New Drug Application; 21 CFR 812 Investigational Device Exemptions
ICH GCP: Chapter E6, § 5.18
58. Do you have template monitoring checklists and reports prepared?
 Yes
Great job!
 No
Corrective Action: Study monitoring must be documented. For assistance in creating monitoring tools, procedures and
reports, please contact OCR at 567-8555 or OCRMail@uthscsa.edu to request a consultation.
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Sponsor Investigator
FDA: 21 CFR 312 Investigational New Drug Application; 21 CFR 812 Investigational Device Exemptions
59. Have you completed the UTHSCSA required Sponsor-Investigator training?
 Yes
Great job!
 No
Corrective Action: Complete the CITI course and print a copy of the Certificate of Completion for this course and place in
the research team Training Binder or appropriate Regulatory file.
Where to find more information
IRB Policy: Research Ethics Education Policy and Procedure
HOP Policy: Research Scope of Practice for Study Personnel
OCR Policies: Principal Investigator Responsibilities; Sponsor Investigator
OCR Required Training: Sponsor Investigator Training
ClinicalTrials.gov: Protocol Registration System
60. Do you have documentation on file, such as Form FDA 1571 or an FDA IDE application?
 Yes
Great job!
 No
Corrective Action: Establish documentation of the IND application or Exemption (drug) or IDE application or Exemption
(device). Contact the OCR at 567-8555 or OCRMail@uthscsa.edu to request assistance.
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Sponsor Investigator
FDA: 21 CFR 312 Investigational New Drug Application; 21 CFR 812 Investigational Device Exemptions
61. Are all correspondence to and from the Sponsor and/or FDA on file?
 Yes
Great job!
 No
Corrective Action: Obtain/retrieve copies of all correspondence pertaining to your study to and from sponsor and/or FDA
for your records. If sponsor or FDA correspondence was included in any IRB submissions, the OIRB will have a copy in
the IRB records. You may contact the OIRB to obtain a copy from the IRB records ((210)567-8250). After finishing this
survey, contact the Office of Clinical Research to request assistance. See http://research.uthscsa.edu/ocr/ for contact
information.
Where to find more information
OCR Policies: Principal Investigator Responsibilities; Study Documentation and Data Management
END OF SURVEY:
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available in approximately one month. You will receive an email when the feedback is ready for your review. Click the
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