Report all noncompliance issues that have an adverse effect on the safety or welfare of the study subjects, on the data collected, or are related to a breach of confidentiality within 10 business days of the site becoming aware of the noncompliance.
Use the Subject Safety Reports to submit a noncompliance issue. Acknowledgement of receipt will be provided to the submitting party via e-mail.
What is Noncompliance with the Protocol?
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.
- 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?
Any variation from requirements as listed in the approval letter, amendment letters, reapproval letters and other Schulman communications, including the Board’s requirements posted on the Schulman website.
- Failure to contact a subject’s primary care physician (PCP) after the subject has indicated on the approved 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.
- Failure to submit investigator and/or site location changes to Schulman for review prior to implementing.
What is Noncompliance with Regulations?
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.