Deviations and Noncompliance
What Must Be Reported to the IRB?
All noncompliance issues that have an adverse effect on the safety or welfare of the study subject(s), and/or on the data collected, and/or are related to a breach of confidentiality must be reported to Schulman within ten (10) days of the site becoming aware of the non-compliance. Use the 
Noncompliance with the Protocol, Board Requirements, or Regulations Report Form (Noncompliance Form) to report any noncompliance issues to Schulman.
What is Noncompliance with the Protocol?
Noncompliance with the protocol is any variation and or omission from the approved study protocol, whether intentional or unintentional (including deviations for which the sponsor has provided a written waiver) that may affect the subject’s rights, safety, or well-being and/or the completeness, accuracy and reliability of the data. Examples include, but are not limited to:
Deviations from the inclusion/exclusion criteria.
Omission of or delay in conducting safety monitoring procedures.
Incorrect administration of study products or errors in adherence to study procedures.
What is Noncompliance with Board Requirements?
Noncompliance with Board requirements is any variation from requirements as listed in the approval letter, amendment letters, reapproval letters, other Schulman communications, including the Board’s requirements posted on the Schulman website. Examples include but are not limited to:
Failure to contact a subject’s primary care physician (PCP) after the subject has indicated on the approved Informed Consent (IC) that his/her PCP is to be notified.
Failure to comply with the Board’s requirements for consenting a family member or employee.
Failure to follow Board’s requirement regarding proof of guardianship when consenting a minor
Failure to respond to the Board’s request for information, required reports and/or documentation, etc., within the specified timeframe.
Errors in obtaining informed consent.
What is Noncompliance with Regulations?
Noncompliance with regulations is any variation from the federal, state/provincial or local regulations regarding clinical research. It is the PI/QI’s responsibility to be familiar with and follow all applicable regulations.
For more information, please reference Investigator Noncompliance.