Event Reports

Adverse Events

The IRB definition of an Adverse Event is an experience, the nature, severity, or frequency of which, is not consistent with the current risk information described in the investigational plan, protocol, or consent form.

 

An adverse event is any occurrence or situation during the course of a research project that:

  1. Was harmful to a subject taking part in the research, or
  2. Increased the probability of harm to subjects taking part in the research such as:
    • Physical injury to a participant;
    • Psychological, social, or economic harm to a participant;
    • Breaches of protocol, such as breakdowns in the informed consent process, violations of confidentiality of data or privacy of a participant, and complaints by participants or their representatives; and
    • Any serious or continuing noncompliance with federal regulations by investigators or research staff.

Social and behavioral interviews and studies that deal with sensitive issues may also give rise to adverse events, such as research subjects becoming very upset over the nature of the questions or the unintentional release of their identities or other such personal information due to the loss of a computer storing relevant data. Unexpected accidents that occur in the course of a research project, for example, a subject in an exercise study falling off an exercise bike or treadmill, should also be reported. The death or serious injury of a research subject is a serious adverse event.

Investigators are required to report any adverse event that occurs during the protocol approval period.

 

An adverse event form must be completed and submitted to the Office of Research Compliance within 10 calendar days of the occurrence (ORC_Research@Mercer.edu).

In the event of a Serious Adverse Event, the Research Compliance Office should be notified by telephone: 478-301-4101 or email ORC_Research@Mercer.edu AND a written report must be submitted within 10 calendar days of the occurrence.

Adverse Event Behavioral Form

Use this form to report adverse events that occur during social or behavioral studies. These events are typically associated with minimal risk studies such as those during which human subject participants may are exposed to sensitive issues they may find highly upsetting.

On-Site Adverse Event Report Form

Use this form to report on-site adverse events that occur during clinical trials and FDA approved minimal risk studies.

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Protocol Deviations and Violations

A protocol violation is any accidental or unintentional change to, or non-compliance with the IRB approved research protocol without prior sponsor and IRB approval.

 

Violations to approved protocols generally increase risk or decrease benefit, affect the subject’s rights, safety, or welfare, or impact the integrity of the data such as research that:

  1. was harmful to a subject taking part in the research, or
  2. increased the probability of harm to subjects taking part in the research such as:
    • Physical injury to a participant;
    • Psychological, social, or economic harm to a participant;
    • Breaches of protocol, such as breakdowns in the informed consent process, violations of confidentiality of data, or privacy of a participant, and complaints by participants or their representatives; and
    • Any serious or continuing noncompliance with federal regulations by investigators or research staff;
    • Loss of laptop computer that contained identifiable, private information about subjects;
    • Accidental distribution of incorrect medication or dose; and
    • Not following inclusion/exclusion criteria

 

A protocol deviation is any accidental or unintentional changes to, or; non-compliance with the research protocol that does not increase risk or decrease benefit or; does not have a significant effect on the subject’s rights, safety, or welfare; and/or on the integrity of the data.

 

A deviation may be due to the research subject’s non-adherence, or an unintentional change to or non-compliance with the research protocol on the part of a researcher including:

  1. Failure to collect an ancillary self-report questionnaire;
  2. A rescheduled study visit; or
  3. A subject’s refusal to complete scheduled research activities

Deviations may result from the action of the subject, researcher, or research staff.

 

In the event of protocol violation or deviation, the Research Compliance Office should be notified IMMEDIATELY by telephone: 478-301-4101 and a written report must be submitted as soon as possible.

Protocol Deviation/Violation Report Form

To report a protocol deviation or violation, submit this form to the ORC as soon as possible.

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