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, and/or IntegReview’s requirements, IntegReview requires reporting of all of the following for review/approval:

Report Immediately:


• 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
• Any significant new findings developed during the course of the research and after study completion which may relate to the subject’s willingness to continue participation will be provided to the subjects.
• Modifications to previously approved documents
• Receipt of 483, Determination letter or Warning letter
• If the Principal Investigator’s license is suspended, revoked, placed on probation or restricted in any state or country
• Safety information that may help to provide additional protections for subject’s safety and well being, throughout the course of the study and after study completion.
• Communication of results from a research study to subjects when those results directly affect their safety or medical care

Report within 10 days of discovery:


• Serious Adverse Events reports – 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 effect reports – any SAE on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
• Unanticipated problem reports – any experience that is (1) unexpected in terms of severity or frequency; and (2) involves risks to participants or others; and (3) is more likely than not related to the research (not limited to the test article or procedures).
• Reports of pregnancy
• Non–compliance issues – failure by an investigator to follow the research protocol, IntegReview’s requirements, applicable regulations or to protect human research subjects
• Serious non–compliance issues – 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 – a pattern of repeated non-compliance or serious non-compliance that might adversely affect the rights and welfare of human subjects
• Significant Protocol deviations – 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)
• Revisions to the Investigator’s Brochure

Submit prior to publication/distribution:


• Request for modification(s) to the IntegReview approved Informed Consent document(s)
• Request for new and/or modifications to IntegReview approved recruiting materials

Submit four (4) weeks prior to IntegReview approval expiration date (as indicated on the IRB approval letter):


• Continuing or periodic (annual) review documents – IntegReview will initiate a reminder 7 weeks, 3 weeks and 1 week prior to IRB approval expiration date

Submit upon completion of study:


• 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