Audit Tool 2003 Version 1.00 pf
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Audit of Approved Research on Human SubjectsMichigan State UniversityUniversity Committee for Research Involving Human SubjectsThis form is to be used by representatives of the University Committee on Research Involving Human Subjects (UCRIHS), Michigan State University, when conducting an audit of research it has approved. The purpose of UCRIHS activities, including auditing approved research, is to ensure the protection of human research subjects.Dates covered by audit: toLeader of audit team:Members of audit team:Date principal investigator notified:Date on-site audit initiated:Location(s) for on-site audit:Date on-site audit completed:Signature of audit team leader:UCRIHS Audit Tool - 2003Version 1.00, 02/04/03Section 1. Project DescriptionUCRIHS Database UCRIHS File1.1) IRB # 1.2) Title1.3) Principal Investigator1.4) Review Classification (full, expedited, exempt). If Full review: Complete section 6. Adverse Events1.5) Expiration Date1.6) Date of last subject recruited1.7) Approved Consent Form (Yes / No / Oral / Waived). If yes or oral: Complete Section 2. Consent process1.8) Approved Survey Instrument (Yes/No). If yes: Complete Section 3. Survey process1.9) Approved Advertisement (Yes/No). If yes: Complete Section 4. Recruitment1.10) Approved Brochures (Yes/No). If yes: Complete Section 5. Education of Subjects1.11) Clinical Trial (Yes/No): If yes: Complete Section 7. Clinical Trial1.12) Notes on project description, e.g., does ...
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Audit of Approved Research on Human Subjects
Michigan State University
University Committee for Research Involving Human Subjects
Dates covered by audit:
to
Leader of audit team:
Members of audit team:
Date principal investigator notified:
Date on-site audit initiated:
Location(s) for on-site audit:
Date on-site audit completed:
Signature of audit team leader:
This form is to be used by representatives of the University Committee on Research
Involving Human Subjects (UCRIHS), Michigan State University, when conducting an audit
of research it has approved. The purpose of UCRIHS activities, including auditing
approved research, is to ensure the protection of human research subjects.
UCRIHS Audit Tool - 2003
Version 1.00, 02/04/03
UCRIHS Database
UCRIHS File
1.1) IRB #
1.2) Title
1.3) Principal Investigator
1.4) Review Classification (full, expedited, exempt).
If
Full review: Complete section 6. Adverse Events
1.5) Expiration Date
1.10) Approved Brochures (Yes/No).
If yes: Complete Section 5. Education of Subjects
1.12) Notes on project description, e.g., does information match that found in investigator files.
Section 1. Project Description
1.6) Date of last subject recruited
1.7) Approved Consent Form (Yes / No / Oral / Waived).
If yes or oral: Complete Section 2. Consent
process
1.8) Approved Survey Instrument (Yes/No).
If yes: Complete Section 3. Survey process
1.9) Approved Advertisement (Yes/No).
If yes: Complete Section 4. Recruitment
1.11) Clinical Trial (Yes/No):
If yes: Complete Section 7. Clinical Trial
2.13) Notes on oral consent forms:
2.4) Total number of research subjects' consent forms audited
[Minimum is 10% or 30, whichever
is larger. If less than 30 subjects, all should be included in audit. If there are more than one
consent form per subject, the most recent form should be included in audit.]
Section 2. Consent process
. If written consent - answer 2.1 through 2.9. If oral consent - answer 2.1,
2.2, and 2.10 through 2.13.
2.12) If oral consent: Number and percentage of subjects from question 2.11 that have
documented use of script (dated, signed by researcher, witness).
2.9) Notes on written consent forms:
2.2) If no: describe difference
2.10) If oral consent: Is there an approved script (Yes / No)
2.11) If oral consent: Total number of research subjects' audited
[Minimum is 10% or 30,
whichever is larger. If less than 30 subjects, all should be included in audit.]
2.8) Number and percentage of forms from question 2.7 that are dated within approval
period (not before date in question 2.3, nor after expiration date in question 1.5).
2.7) Number and percentage of forms from question 2.4 that are signed and dated by
subject, and match IRB approved content and date stamp.
2.1) Does consent process follow approved protocol? (Yes / No) [note: observation of actual
consent may be necessary]
2.3) Date of approved consent form (most recent date stamp)
2.5) Number and percentage of forms from question 2.4 that match IRB approved form
for content & date stamp.
2.6) Number and percentage of forms from question 2.4 that are signed and dated by
subject.
Section 3. Survey process
3.1) Does survey instrument match the IRB approved tool? (Yes/No)
3.3) Does survey process follow approved protocol? (Yes / No)
3.2) If no: describe difference
3.4) If no: describe difference
3.5) Notes on survey process:
Section 4. Recruitment.
Answer questions 4.1 through 4.4 and 4.10. If applicable, answer
questions 4.5 through 4.9. If not applicable, answer NA.
4.1) Does recruitment process follow approved protocol? (Yes / No)
[note: may require audit of
dissemination methods used for advertisement]
4.3) Does advertisement(s) match the IRB approved material(s)? (Yes / No)
[note: may require
audit of posters, news releases, etc.]
4.5) Number of subjects approved for inclusion in study by UCRIHS, if applicable.
4.6) Number of subjects in study, if applicable.
4.7) Number of subjects matching study inclusion criteria, if applicable.
4.8) Number of subjects approached, if applicable.
4.9 Number of subjects approached that did not consent, if applicable.
4.2) If no: describe difference
4.4) If no: describe difference
4.10) Notes on recruitment:
Section 5. Education of Subjects
5.1) Does brochure(s) match IRB approved material? (Yes / No)
5.3) Notes on Education:
5.2) If no: describe difference
Section 6. Adverse Events.
If Clinical Trial, complete only questions 6.1 through 6.4, and
Section 7. Clinical Trial (questions 6.5 through 6.15 are repeated in Section 7)
6.1) Number of subjects who complained to
UCRIHS
about protocol, recruitment, adverse events,
etc
6.2) Number of subjects who complained to
investigator
about protocol, recruitment, adverse
events, etc
6.3) Number of adverse events (include all) reported to UCRIHS.
6.4) Number of adverse events (include all) in investigator files.
6.5) Number of serious adverse events (MSU subjects only) reported to UCRIHS.
6.6) Number of serious adverse events (MSU subjects only) in investigator files.
6.8) Does system for security of data follow approved protocol? (Yes / No)
6.10) Are the data organized (yes / no)
6.12) Number of IND reports
[e.g., drug brochures]
from pharmaceutical company, if applicable.
6.13) Number of subjects who received compensation if applicable
[note: compensation should be
included in language of consent form].
6.14) Number and percentage of subject from question 6.9 that had compensation verified (e.g.,
payment records), if applicable.
6.7) Notes on adverse events, e.g., did investigator respond to adverse events?:
6.9) If no: describe issues (e.g., who has access to data, subject names & ID's).
6.11) If no: describe issues, e.g., paper files, electronic files, location, procedures.
6.15) Notes on compensation:
Section 7. Clinical Trial
7.1) Does the therapeutic regime follow the approval protocol (Yes / No)
7.3) Does data gathering follow the approved protocol (Yes / No)
7.5) Number of serious adverse events (MSU subjects only) reported to UCRIHS.
7.6) Number of serious adverse events (MSU subjects only) in investigator files.
7.8) Does system for security of data follow approved protocol? (Yes / No)
7.10) Are the data organized (yes / no)
7.12) Number of IND reports
[e.g., drug brochures]
from pharmaceutical company, if applicable.
7.13) Number of subjects who received compensation if applicable
[note: compensation should be
included in language of consent form].
7.14) Number and percentage of subject from question 6.9 that had compensation verified (e.g.,
payment records), if applicable.
7.11) If no: describe issues, e.g., paper files, electronic files, location, procedures.
7.15) Notes on compensation:
7.2) If no: describe difference.
7.4) If no: describe difference.
7.7) Notes on adverse events, e.g., did investigator respond to adverse events?:
7.9) If no: describe issues (e.g., who has access to data, subject names & ID's).
Section 8. Other Comments
Use this space for additional comments not covered in the sections above. If referring to prior sections
please note section (or question) number.
8.1)
