Unanticipated problems are logged on a common form, which is available at the bottom of the subject’s page in EDC. Click +New to log a new event. The maximum number of new events which can be added is 10.
The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to subjects or others to include, in general, any incident, experience, or outcome that meets all of the following criteria:
- Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are described in the protocol-related documents, such as the Institutional Review Board (IRB)-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- Related or possibly related to participation in the research (“possibly related” means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
- Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Unanticipated Problem Involving Risks to Participants or Others Assessment
Was the incident, experience, or outcome unexpected in terms of nature, severity, or frequency:
If the incident was unexpected as defined per protocol, indicate “Yes.”
Given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied.
Was the incident, experience, or outcome related or possibly related to participation in the research:
If the incident was related or possibly related to participation in the research study report “Yes.”
Does the incident, experience, or outcome suggest that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized:
If the incident suggests that the research places subjects or others at greater risk of harm indicate “Yes.”
Date of start of unanticipated problem:
Report the start date of the unanticipated problem. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
Date center became aware of unanticipated problem:
Report the date that the research site/center became aware of the unanticipated problem. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
Date unanticipated problem reported to IRB:
Report the date that the unanticipated problem was reported to the IRB. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
If unanticipated problem has not been reported to the IRB by the time of data entry, mark field as Intentionally Left Blank:
- Select Intentionally Left Blank from the data field’s Actions menu.
- In the dialog, select Other and indicate that event has not been reported at the time of data entry.
- Click Save.
This field should be updated, once the event has been reported to the IRB.
Type of unanticipated problem (select all that apply)
Select the type of unanticipated problem (check all that apply). Types of unanticipated problem include:
- Breach of confidentiality
- An unexpected event related or possibly related to participation in the research that puts the subject or others at greater risk of harm than was previously known
- Other, Specify
Specify other type of unanticipated problem:
This field only appears in the EDC if Other, specify is selected for “Type of unanticipated problem”. Report the other unanticipated problem type (up to 200 characters).
Unanticipated Problem Description:
Provide a short description of the unanticipated problem (up to 200 characters).
Plan of action taken to address unanticipated problem:
Provide a brief description of the plan of action taken to address the unanticipated problem (up to 200 characters)
Unanticipated Problem Updates
Complete this section if additional information is discovered after the initial submission of the Unanticipated Problem form or as needed after the initial submission of the unanticipated problem. If more than one update is required, click +New Section to capture each update. This section allows for up to 50 updates.
Date of update:
Report the date of the Unanticipated Problem update. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
Update description:
Describe the Unanticipated Problem update in the textbox (up to 200 characters).
CCG v1.0 | CRF v1.3
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