Reporting Unanticipated Problems

This website includes a page devoted to the discussion of reportable events. The information below relates to the PI's responsibility for reporting these events.

Unanticipated Problems

CHOP policy requires prompt reporting of any unanticipated problem involving risks to subjects or others to the IRB within 1 week of identification. Deaths and life-threatening events must be reported within 48 hours of discovery. Unanticipated problems include:

1. Adverse events that are serious, not anticipated and related to the research activity (SAEs). AEs that are not serious can be summarized at the time of continuing review.

2. Other unanticipated problems involving risks to subjects that are unexpected and related/possibly related to the research. Examples of reportable events include breaches of confidentiality and participant pregnancy or incarceration.

3. Protocol deviations should be considered unanticipated problems. When they represent unreasonable risks to participants they must be reported promptly even if the subject did not suffer an SAE (see below).

The IRB website contains additional information including, IRB SOP 408: Unanticipated Problems and the webpage on Reportable Events.

Protocol Deviations or Violations

Protocol deviations or violations are common during the execution of clinical research study. Some are not preventable - a subject fails to show up for a scheduled appointment or doesn't adhere to the drug treatment schedule - while others are due to one or more failures on the part of the study team. Most of the latter protocol deviations result from a failure to strictly follow the protocol.

There are occasions when a failure to comply with the protocol may be considered a failure to protect the rights, safety, and welfare of subjects because the non-compliance exposes subjects to unreasonable risks. For example, failure to adhere to inclusion/exclusion criteria that are specifically intended to exclude subjects for whom the study drug or device poses unreasonable risks may be considered failure to protect the rights, safety, and welfare of the enrolled subject. Similarly, failure to perform safety assessments intended to detect drug toxicity within protocol-specified time frames (e.g., CBC for an oncology therapy that causes neutropenia) may be considered failure to protect the rights, safety, and welfare of the enrolled subject. Investigators should seek to minimize such risks by adhering closely to the study protocol. From: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects.

These events must be reported to the IRB via the eIRB system through the Reportable Events pathway.