To ensure compliance with the Code of Federal Regulations (CFR), Parts 56.108 (a) (3), 312.32 (c) (1) (i) 312.66 as well as International Conference on Harmonisation (ICH), E6: Good Clinical Practice: Consolidated Guideline, IntegReview requires reporting of all of the following for review/approval:

• Changes in research that were initiated without IRB review and approval to eliminate apparent immediate hazards to the human subjects to ensure the continued safety and welfare of subjects.
• Serious Adverse Events (report within 10 working days of learning of the event) – Suspected to be associated with the use of the drug or the research procedures, and is unexpected (not included in the Investigator Brochure); any adverse drug experience occurring at any dose that results in any of the following outcomes: death, a life threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
• Unanticipated adverse device effects (report within 10 days of learning of the effect)
• Unanticipated problems (report within 10 working days of learning of the problem) – any problem that either (1) is unforeseen and (2) caused harm to participants or others or indicates that the risks to participants or others is increased.
• Non-compliance issues (report within 10 days of discovery) - an action by an investigator that significantly deviates from the IRB approved research protocol and adversely affects the safety of research participants, IntegReview’s requirements, applicable regulations or failure to protect human research subjects.
• Serious non-compliance issues (report within 10 days of discovery) - failure by an investigator to follow the research protocol, IntegReview’s requirements, applicable regulations or to protect human research subjects in a way that adversely affects the rights and welfare of human subjects
• Continuing non-compliance issues (report within 10 days of discovery) – A pattern of repeated non-compliance or serious non-compliance that might adversely affect the rights and welfare of human subjects
• Significant Protocol deviations (report within 10 days of discovery) – those that deviate from the approved protocol and affect or potentially affect the safety of subjects. IntegReview does not consider protocol deviations to be different from protocol violations.
• IND Safety Reports (submit within 10 working days of receipt)
• Revisions to the Investigator's Brochure
• Request for modification(s) to the IntegReview approved Informed Consent document(s)
• Request for new and/or modifications to IntegReview approved recruiting materials
• Continuing review documents
• Notification of study closure

You may obtain answers to questions, express concerns, and convey suggestions regarding IntegReview’s Human Research Protection Program (HRPP) via e-mail to or by dialing (512) 326-3001, extension 207.

We welcome you to complete IntegReview’s Customer Survey to offer suggestions or to voice any concerns regarding our processes or services. Customer surveys that reflect concerns will be reviewed by IntegReview’s Quality Systems Manager.