The University of Texas at Dallas
Quality Improvement Program for Human
Subjects Research
Date of Inspection:
Principle Investigator:
IRB #:
Title of Study:
IRB Observer:
A. Study Progress YES NO
Are all the experimental records available for review
Do the experimental records appear to be in order and up-to-date?
Do the experimental records reflect the protocol was followed?
Is there documentation to support PI/CO-PI involvement in approved
procedures?
Research conducted at any other sites?
If YES, describe:
Study currently closed to enrollment?
Has the study been published?
If YES, does the IRB have a copy of the published material?
B. Modification Review Process YES NO
Number of modification listed in Investigator’s records:
Does this match the IRB file?
Modification submitted and approved before implementation?
C. Continuation Review Process YES NO
Date of last CR:
Number of participants approved for enrollment:
Number Enrolled:
Reported number of participants consistent with last CR report?
Number of participants withdrawn:
Rationale for participants’ withdrawal?
D. Reporting of Adverse Events: YES NO
Number of AEs:
Number matches IRB file?
Were the AEs submitted in a timely fashion?
Is there a Data Safety Monitoring Board for this study?
If YES, describe:
PARTICIPANTS RECORDS
Participants Enrollment YES NO
Does the participant meet inclusion/exclusion criteria?
Consent Process
Who obtained informed consent?
Is there documentation to support PI/Co-PI involvement in the
consent process?
Were these individuals of the study team approved by the IRB?
What is the date that the initial consent form was signed?
What is the date of the first research procedure?
Is there a consent form for the participants enrolled?
Was the IRB-approved form used?
Is the consent form appropriately signed and dated?
Is there any indication in the study records that a copy of the consent
document was not provided to the subject?
Research Procedures YES NO
Is the date of the first procedure after the date the consent form was
signed?
Were the procedures implemented as approved by the IRB?
Were the procedures for this subject documented in the experimental
records?
Is there documentation that either the PI or Co-PI saw the subject during
the scheduled visits or reviewed the experimental records for the visits?
Reviewers’ comments:
Reviewers’ Signature(s):
Reviewers’ names typed: