Compliance: Adherence to all research related requirements, good clinical practice requirements, CPHS requirements and applicable regulatory requirements.
Noncompliance: Noncompliance is a failure by an investigator to abide by research related requirements, good clinical practice requirements, CPHS requirements and applicable regulatory requirements. Some examples of noncompliance include, but are not limited to:
- Failure to obtain approval for research prior to initiating the research activities,
- Continuing research activities beyond the expiration date without obtaining continuing review approval,
- Failure to obtain informed consent when required,
- Failure to file an adverse event report,
- Implementing changes to the protocol without prior approval,
- Performance of research at an unapproved site, or
- Failure to adhere to the approved protocol.
Serious Noncompliance: An act or omission to act that has the potential to increase a physical, psychological, safety, or privacy risk to research participants.
Continuing Noncompliance: A repeated pattern, act, or omission to act that suggests a future likelihood of reoccurrence of the noncompliance.
Reporting to CPHS – CPHS encourages reporting of noncompliance by the Principal Investigator (PI), members of the research team or others. When a report of noncompliance is made by someone other than the Principal Investigator, the confidentiality of the reporter will be maintained. Reporter names will not be disclosed to the individuals involved in the complaint, unless disclosure is required to reconcile the situation.
CPHS may receive an allegation or a report of noncompliance by many means that include, but are not limited to:
- Voluntary notification by the Principal Investigator,
- Principal Investigator not responding to ORSC or CPHS queries,
- Information given by other staff of the institution,
- Information given by other members of the research team,
- Monitoring reports,
- Audit reports, or
- Complaints from research subjects.
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