Research Study
- linkId: nme1
Study Title
- linkId: nme1.1
Study Title from the Informed Consent
- linkId: nme1.1_help
IRB Protocol Number
- linkId: nme1.3
Number assigned by IRB; this number is the same as that on the Consent Form
- linkId: nme1.3_help
Status
- linkId: nme1.4
- Answers: 4 options
Status of study research activities
- linkId: nme1.4_help
If partial, please explain:
- linkId: nme1.5
- Enable When: todo
Explanation for voluntary hold on new participant enrollment.
- linkId: nme1.5_help
Organization/Site
- linkId: nme7
Where Adverse Non-Medical Event Occurred
- linkId: nme7.1
Did the Adverse Non-Medical Event occur at the lead principal investigator site? *
- linkId: nme7.1.8
- Answers: 2 options
Select "Yes" if the Adverse Non-Medical Event occurred at the lead principal investigator site, the study coordinating center or other administrative unit for the overall study.
- linkId: nme7.1.8_help
Did the Adverse Non-Medical Event occur at one of the relying sites? *
- linkId: nme7.1.11
- Enable When: todo
- Answers: 2 options
External Data For linkId nme7.1.9
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Flags:
- linkId: ExternalDataFor_nme7.1.9
If the Adverse Non-Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the relying institution and relying site principal investigator details below.
- linkId: nme7.1.9
- Enable When: todo
This question and its answer will not print on the Adverse Non-Medical Event Form but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details.
- linkId: nme7.1.9_help
If the Adverse Non-Medical Event occurred at another organization (unrelated to the lead principal investigator organization/site or relying sites), fill in the details below.
- linkId: nme7.1.12
- Enable When: todo
Name of organization/site where the Adverse Non-Medical Event occurred
- linkId: nme7.1.1
- Enable When: todo
City
- linkId: nme7.1.2
- Enable When: todo
State
- linkId: nme7.1.3
- Enable When: todo
Country
- linkId: nme7.1.4
- Enable When: todo
Responsibility for Adverse Non-Medical Event Reporting
- linkId: nme7.2
- Enable When: todo
If the Adverse Non-Medical Event occurred at a relying site or at another organization (unrelated to the lead principal investigator organization/site or relying sites), will the lead principal investigator site be recording the Adverse Non-Medical Event? *
- linkId: nme7.2.8
- Enable When: todo
- Answers: 2 options
Select "Yes" if the Adverse Non-Medical Event is being recorded by the lead principal investigator site, the study coordinating center or other administrative unit for the overall study.
- linkId: nme7.2.8_help
Name of organization/site which is recording the Adverse Non-Medical Event
- linkId: nme7.2.1
City
- linkId: nme7.2.2
State
- linkId: nme7.2.3
Country
- linkId: nme7.2.4
Location where Adverse Non-Medical Event occurred. Adverse non-medical events are: unexpected, related or possibly related to participation in the research, and place the participants or others at a greater risk of harm than was previously known or recognized.
- linkId: nme7_help
Site Principal Investigator for the site where Adverse Non-Medical Event occurred
- linkId: nme8
- Enable When: todo
First Name
- linkId: nme8.1
First or given name of the site PI
- linkId: nme8.1_help
Last Name
- linkId: nme8.4
Surname or family name
- linkId: nme8.4_help
Suffix
- linkId: nme8.5
Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
- linkId: nme8.5_help
Degree(s)
- linkId: nme8.6
Professional and Academic degrees of the site principal investigator
- linkId: nme8.6_help
Phone
- linkId: nme8.2
10 digit phone number, including area code
- linkId: nme8.2_help
- linkId: nme8.3
Principal Investigator at Relying Site conducting the study
- linkId: nme8_help
Report
- linkId: nme3
Non-medical adverse event report
- linkId: nme3_help
Report Date
- linkId: nme3.1
Date report is created
- linkId: nme3.1_help
Report Status
- linkId: nme3.2
- Answers: 2 options
Indicator if report is the Initial report or follow-up report
- linkId: nme3.2_help
Select at least one of the following criteria:
- linkId: nme3.3
Details about adverse non-medical event
- linkId: nme3.3_help
New information resulted in unexpected change in risks of the research
- linkId: nme3.3.4
Indicator if new information resulted in unexpected change in risks of research
- linkId: nme3.3.4_help
New or increased risk
- linkId: nme3.3.5
- Enable When: todo
Date:
- linkId: nme3.3.5.1
Date new or increased risk first documented
- linkId: nme3.3.5.1_help
Date discovered:
- linkId: nme3.3.5.2
Date new or increased risk discovered
- linkId: nme3.3.5.2_help
Description:
- linkId: nme3.3.5.3
Description of new or increased risk
- linkId: nme3.3.5.3_help
Unanticipated Problem Involving Risk to Participants or Others
- linkId: nme3.3.6
Indicator if problem Involved risk to participants or others
- linkId: nme3.3.6_help
Unanticipated Problem
- linkId: nme3.3.7
- Enable When: todo
Event date:
- linkId: nme3.3.7.1
Date event occurred
- linkId: nme3.3.7.1_help
Date event became aware to study team:
- linkId: nme3.3.7.2
Date site research team first became aware of unanticipated problem
- linkId: nme3.3.7.2_help
Event Summary:
- linkId: nme3.3.7.3
Summary description of unanticipated problem
- linkId: nme3.3.7.3_help
Was this event Unexpected?
- linkId: nme3.3.7.4
- Answers: 2 options
Indicator if unanticipated problem was unexpected
- linkId: nme3.3.7.4_help
If yes, please explain:
- linkId: nme3.3.7.5
- Enable When: todo
Explanation for why unanticipated problem was unexpected
- linkId: nme3.3.7.5_help
Was this event Related or Possibly Related to participation in the research?
- linkId: nme3.3.7.6
- Answers: 2 options
Unanticipated problem associated with participation in the research study
- linkId: nme3.3.7.6_help
If yes, please explain:
- linkId: nme3.3.7.7
- Enable When: todo
Explanation for why unanticipated problem is associated with participation in this research
- linkId: nme3.3.7.7_help
Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known?
- linkId: nme3.3.7.8
- Answers: 2 options
Indicator if unanticipated problem increased risk of harm to participants
- linkId: nme3.3.7.8_help
If yes, please explain:
- linkId: nme3.3.7.9
- Enable When: todo
Explanation for why unanticipated problem is associated with increased risk of harm for research participants
- linkId: nme3.3.7.9_help
Protocol Deviation (accidental or unintentional)
- linkId: nme3.3.8
Indicator protocol deviation was accidental or unintentional
- linkId: nme3.3.8_help
Protocol Deviation (Non-Compliance)
- linkId: nme3.3.9
- Enable When: todo
Date:
- linkId: nme3.3.9.1
Date non-compliance first identified
- linkId: nme3.3.9.1_help
Date discovered:
- linkId: nme3.3.9.2
Date site research team first discovered non-compliance protocol deviation
- linkId: nme3.3.9.2_help
Description:
- linkId: nme3.3.9.3
Description of non-compliance protocol deviation
- linkId: nme3.3.9.3_help
Does the deviation involve any of the following? (Select all that apply)
- linkId: nme3.3.9.4
Failure to obtain informed consent when IRB deemed required
- linkId: nme3.3.9.4.1
Informed consent not obtained when required by IRB
- linkId: nme3.3.9.4.1_help
Modifying the protocol without IRB approval, except to avoid hazard to participants
- linkId: nme3.3.9.4.2
Protocol modified without IRB approval
- linkId: nme3.3.9.4.2_help
Conducting research prior to IRB approval, during an IRB suspension or after IRB approval ends
- linkId: nme3.3.9.4.3
Conducting research without IRB approval
- linkId: nme3.3.9.4.3_help
Explain any Checked items
- linkId: nme3.3.9.4.4
- Enable When: todo
Explanation for why protocol deviation category checked
- linkId: nme3.3.9.4.4_help
Was the deviation a substantive change from the protocol adversely affecting any of the following? (Select all that apply)
- linkId: nme3.3.9.5
The rights, welfare, or safety of the participants
- linkId: nme3.3.9.5.1
The integrity of the research area
- linkId: nme3.3.9.5.2
The participants' willingness to continue participation
- linkId: nme3.3.9.5.3
Explain any Checked items
- linkId: nme3.3.9.5.4
- Enable When: todo
A breach of Confidentiality
- linkId: nme3.3.10
Indicator of breach of confidentiality
- linkId: nme3.3.10_help
Breach of Confidentiality
- linkId: nme3.3.11
- Enable When: todo
Date breach occurred
- linkId: nme3.3.11.1
Date breach of confidentiality first documented
- linkId: nme3.3.11.1_help
Date discovered:
- linkId: nme3.3.11.2
Date site study team discovered breach of confidentiality
- linkId: nme3.3.11.2_help
Description:
- linkId: nme3.3.11.3
Breach of confidentiality description
- linkId: nme3.3.11.3_help
Incarceration of a participant in a protocol not approved to enroll prisoners
- linkId: nme3.3.12
Indicator of a study participant incarcerated when the protocol is not approved for prisoner enrollment
- linkId: nme3.3.12_help
Incarceration
- linkId: nme3.3.13
- Enable When: todo
Date:
- linkId: nme3.3.13.1
Date site first documented participant incarceration.
- linkId: nme3.3.13.1_help
Date incarceration was discovered:
- linkId: nme3.3.13.2
Data site study team discovered patient incarceration
- linkId: nme3.3.13.2_help
Description:
- linkId: nme3.3.13.3
Description of patient incarceration
- linkId: nme3.3.13.3_help
Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team
- linkId: nme3.3.14
Indicator if participant complaint of unexpected risks was not resolved by study team. Complaint information is related to study site.
- linkId: nme3.3.14_help
Participant Complaint
- linkId: nme3.3.15
- Enable When: todo
Complaint Date:
- linkId: nme3.3.15.1
Date a participant complaint was first documented
- linkId: nme3.3.15.1_help
Date received:
- linkId: nme3.3.15.2
Date site personnel first received a participant complaint
- linkId: nme3.3.15.2_help
Description:
- linkId: nme3.3.15.3
Description of participant unexpected risk complaint
- linkId: nme3.3.15.3_help
Other Type of Adverse Non-Medical Event
- linkId: nme3.3.16
Indicator for other type of Adverse Non-Medical Event
- linkId: nme3.3.16_help
Other Type
- linkId: nme3.3.17
- Enable When: todo
Event date:
- linkId: nme3.3.17.1
Date event occurred
- linkId: nme3.3.17.1_help
Date study team became aware of event:
- linkId: nme3.3.17.2
Date site research team first became aware of the event
- linkId: nme3.3.17.2_help
Event Summary:
- linkId: nme3.3.17.3
Summary description of the event
- linkId: nme3.3.17.3_help
Was this Adverse Non-Medical Event Unexpected?
- linkId: nme3.3.17.4
- Answers: 2 options
Indicator if event was unexpected
- linkId: nme3.3.17.4_help
If yes, please explain:
- linkId: nme3.3.17.5
- Enable When: todo
Explanation for why event was unexpected
- linkId: nme3.3.17.5_help
Was this event Related or Possibly Related to participation in the research?
- linkId: nme3.3.17.6
- Answers: 2 options
Adverse Non-Medical Event association with participation in the research study
- linkId: nme3.3.17.6_help
If yes, please explain:
- linkId: nme3.3.17.7
- Enable When: todo
Explanation for why the event is associated with participation in this research
- linkId: nme3.3.17.7_help
Reporting
- linkId: nme4
Reporting information to Sponsor and both relying and reviewing IRBs
- linkId: nme4_help
Was the Sponsor notified?
- linkId: nme4.1
- Answers: 2 options
Indicator if Sponsor was notified of non-medical adverse event
- linkId: nme4.1_help
Notification date:
- linkId: nme4.2
- Enable When: todo
Date sponsor notified of non-medical adverse event
- linkId: nme4.2_help
Was the IRB notified?
- linkId: nme4.3
- Answers: 2 options
Indicator if study site IRB notified of non-medical adverse event
- linkId: nme4.3_help
Notification date:
- linkId: nme4.4
- Enable When: todo
Date study site IRB notified of non-medical adverse event
- linkId: nme4.4_help
Were any Other Parties notified?
- linkId: nme4.5
- Answers: 2 options
Other parties notified of non-medical adverse event (such as coordinating center, other study sites, FDA)
- linkId: nme4.5_help
List other notified parties
- linkId: nme4.6
- Enable When: todo
Corrective and Preventative Action Plan
- linkId: nme5
Was a Root Cause analysis performed?
- linkId: nme5.1
- Answers: 3 options
Indicataor if analysis of underlying causes or problems that led to the non-medical adverse event was performed
- linkId: nme5.1_help
If yes, provide determination:
- linkId: nme5.2a
- Enable When: todo
Description of what the root cause analysis determined the adverse event was caused by
- linkId: nme5.2a_help
If pending, describe status and interim findings, if any:
- linkId: nme5.2b
- Enable When: todo
Describe status and any interim findings of the root cause analysis
- linkId: nme5.2b_help
Was Corrective Action implemented?
- linkId: nme5.3
- Answers: 3 options
Indicator if corrective action is implemented for non-medical adverse event
- linkId: nme5.3_help
If Corrective Action was implemented or is pending, provide a summary:
- linkId: nme5.4
- Enable When: todo
Summary of corrective action implemented for non-medical adverse event. If still pending, provide a status of the corrective action plan
- linkId: nme5.4_help
Was Preventitive Action implemented?
- linkId: nme5.5
- Answers: 3 options
Indicator if preventative action for non-medical adverse event is implemented
- linkId: nme5.5_help
If Preventitive Action was implemented or is pending, provide a summary:
- linkId: nme5.6
- Enable When: todo
Summary of preventative action implemented for non-medical adverse event. If still pending, provide status.
- linkId: nme5.6_help
Study Protocol and Informed Consent
- linkId: nme6
Description of protocol and informed consent changes
- linkId: nme6_help
Are changes required to the Study Protocol as a result of this report?
- linkId: nme6.1a
- Answers: 2 options
Indicator if changes are required in study protocol resulting from the non-medical adverse event report
- linkId: nme6.1a_help
Reason(s) why changes are not required in the Study Protocol: *
- linkId: nme6.1b
- Enable When: todo
- Answers: 3 options
Justify your decision to not change the Study Protocol (for reasons other than Adverse Non-Medical Event consisted of a missed lab/assessment or missed treatment/dose):
- linkId: nme6.2
- Enable When: todo
Justification for decision not to change study protocol based upon non-medical adverse event report
- linkId: nme6.2_help
Are changes required to the Informed Consent as a result of this report?
- linkId: nme6.3a
- Answers: 2 options
Indicator if changes are required to the informed consent as a result of the non-medical adverse event report
- linkId: nme6.3a_help
Reason(s) why changes are not required in the Informed Consent: *
- linkId: nme6.3b
- Enable When: todo
- Answers: 3 options
Justify your decision to not change the Informed Consent (for reasons other than Adverse Non-Medical Event consisted of a missed lab/assessment or missed treatment/dose):
- linkId: nme6.4
- Enable When: todo
Justification for decision not to change informed consent based upon non-medical adverse event report
- linkId: nme6.4_help
Are notifications or re-consenting of participants required as a result of changes in Study Protocol or Informed Consent?
- linkId: nme6.5
- Enable When: todo
- Answers: 2 options
Indicator if notification or reconsenting of participants is required due to changes in Study Protocol or Informed Consent
- linkId: nme6.5_help
If yes, detail how the notification and/or re-consent will occur:
- linkId: nme6.6
- Enable When: todo
Description of how notification or re-consent will occur
- linkId: nme6.6_help
If no, justify your decision to not notify (re-consent) participants:
- linkId: nme6.7
- Enable When: todo
Rationale for not notifying (re-consenting) study participants
- linkId: nme6.7_help
Optional Attachments
- linkId: nme11
Describe the file that is being attached (optional)
- linkId: nme11.1
Attachment
- linkId: nme11.2
Attachments related to the Adverse Non-Medical Event can be included here.
- linkId: nme11_help
Administrative Use Only
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Flags:
- linkId: ADMIN00
Link ID prefix
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Flags:
- linkId: ADMIN01
- Initial Values: nme
Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
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Flags:
- linkId: ADMIN02
- Initial Values: temporarily unavailable
ID of the Research Study FHIR Resource associated with the study Questionnaire Responses
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Flags:
- linkId: ADMIN03
- Initial Values: temporarily unavailable
Questionnaire Response ID of the local considerations Questionnaire Response, if any
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Flags:
- linkId: ADMIN04