Publication Build: This will be filled in by the publication tooling
| LinkId | Text | Definition | Answer |
|---|---|---|---|
![]() | QuestionnaireResponse | ||
![]() ![]() | Research Study | ||
![]() ![]() ![]() | Study Title | Study of Drug A for arthritis | |
![]() ![]() ![]() | IRB Protocol Number | PRO098765 | |
![]() ![]() ![]() | Status | Temporary Codes nochange: No change in research activities | |
![]() ![]() | Organization/Site | ||
![]() ![]() ![]() | Where Adverse Non-Medical Event Occurred | ||
![]() ![]() ![]() ![]() | Did the Adverse Non-Medical Event occur at the lead principal investigator site? | expandedYes-NoIndicator N: No | |
![]() ![]() ![]() ![]() | Did the Adverse Non-Medical Event occur at one of the relying sites? | expandedYes-NoIndicator Y: Yes | |
![]() ![]() ![]() ![]() | External Data For linkId 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. | [not stated] : Central Campus Test University | | Maria Smith, PhD | Central, MI | |
![]() ![]() ![]() ![]() | Name of organization/site where the Adverse Non-Medical Event occurred | Central Campus Test University | |
![]() ![]() ![]() ![]() | City | Central | |
![]() ![]() ![]() ![]() | State | MI | |
![]() ![]() ![]() ![]() | Country | United States | |
![]() ![]() ![]() | Responsibility for Adverse Non-Medical Event Reporting | ||
![]() ![]() ![]() ![]() | 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? | expandedYes-NoIndicator Y: Yes | |
![]() ![]() ![]() ![]() | Name of organization/site which is recording the Adverse Non-Medical Event | Sample University Medical Center | |
![]() ![]() ![]() ![]() | City | Sample City | |
![]() ![]() ![]() ![]() | State | NC | |
![]() ![]() ![]() ![]() | Country | United States | |
![]() ![]() | Site Principal Investigator for the site where Adverse Non-Medical Event occurred | ||
![]() ![]() ![]() | First Name | Maria | |
![]() ![]() ![]() | Last Name | Smith | |
![]() ![]() ![]() | Degree(s) | PhD | |
![]() ![]() ![]() | Phone | 8901231234 | |
![]() ![]() ![]() | maria.smith@CCTU.med.edu | ||
![]() ![]() | Report | ||
![]() ![]() ![]() | Report Date | 2022-02-27 | |
![]() ![]() ![]() | Report Status | Temporary Codes init: Initial | |
![]() ![]() ![]() | Select at least one of the following criteria: | ||
![]() ![]() ![]() ![]() | New information resulted in unexpected change in risks of the research | true | |
![]() ![]() ![]() ![]() | New or increased risk | ||
![]() ![]() ![]() ![]() ![]() | Date: | 2022-02-27 | |
![]() ![]() ![]() ![]() ![]() | Date discovered: | 2022-02-26 | |
![]() ![]() ![]() ![]() ![]() | Description: | [answer] | |
![]() ![]() ![]() ![]() | Unanticipated Problem Involving Risk to Participants or Others | true | |
![]() ![]() ![]() ![]() | Unanticipated Problem | ||
![]() ![]() ![]() ![]() ![]() | Event date: | 2022-02-26 | |
![]() ![]() ![]() ![]() ![]() | Date event became aware to study team: | 2022-02-27 | |
![]() ![]() ![]() ![]() ![]() | Event Summary: | [answer] | |
![]() ![]() ![]() ![]() ![]() | Was this event Unexpected? | expandedYes-NoIndicator Y: Yes | |
![]() ![]() ![]() ![]() ![]() | If yes, please explain: | [answer] | |
![]() ![]() ![]() ![]() ![]() | Was this event Related or Possibly Related to participation in the research? | expandedYes-NoIndicator Y: Yes | |
![]() ![]() ![]() ![]() ![]() | If yes, please explain: | [answer] | |
![]() ![]() ![]() ![]() ![]() | Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known? | expandedYes-NoIndicator Y: Yes | |
![]() ![]() ![]() ![]() ![]() | If yes, please explain: | [answer] | |
![]() ![]() ![]() ![]() | A breach of Confidentiality | false | |
![]() ![]() ![]() ![]() | Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team | true | |
![]() ![]() ![]() ![]() | Participant Complaint | ||
![]() ![]() ![]() ![]() ![]() | Complaint Date: | 2022-02-27 | |
![]() ![]() ![]() ![]() ![]() | Date received: | 2022-02-27 | |
![]() ![]() ![]() ![]() ![]() | Description: | [answer] | |
![]() ![]() | Reporting | ||
![]() ![]() ![]() | Was the Sponsor notified? | expandedYes-NoIndicator Y: Yes | |
![]() ![]() ![]() | Notification date: | 2022-02-27 | |
![]() ![]() ![]() | Was the IRB notified? | expandedYes-NoIndicator Y: Yes | |
![]() ![]() ![]() | Notification date: | 2022-02-27 | |
![]() ![]() ![]() | Were any Other Parties notified? | expandedYes-NoIndicator Y: Yes | |
![]() ![]() ![]() | List other notified parties | [answer] | |
![]() ![]() | Corrective and Preventative Action Plan | ||
![]() ![]() ![]() | Was a Root Cause analysis performed? | Temporary Codes pending: Pending - Currently under development | |
![]() ![]() ![]() | If pending, describe status and interim findings, if any: | [answer] | |
![]() ![]() ![]() | Was Corrective Action implemented? | Temporary Codes pending: Pending - Currently under development | |
![]() ![]() ![]() | If Corrective Action was implemented or is pending, provide a summary: | [answer] | |
![]() ![]() ![]() | Was Preventitive Action implemented? | Temporary Codes completed: Done, performed or completed | |
![]() ![]() ![]() | If Preventitive Action was implemented or is pending, provide a summary: | [answer] | |
![]() ![]() | Study Protocol and Informed Consent | ||
![]() ![]() ![]() | Are changes required to the Study Protocol as a result of this report? | expandedYes-NoIndicator Y: Yes | |
![]() ![]() ![]() | Are changes required to the Informed Consent as a result of this report? | expandedYes-NoIndicator Y: Yes | |
![]() ![]() ![]() | Are notifications or re-consenting of participants required as a result of changes in Study Protocol or Informed Consent? | expandedYes-NoIndicator Y: Yes | |
![]() ![]() ![]() | If yes, detail how the notification and/or re-consent will occur: | [answer] | |
![]() ![]() | Optional Attachments | ||
![]() ![]() ![]() | Describe the file that is being attached (optional) | [answer] | |
![]() ![]() ![]() | Attachment | No display for Attachment | |
![]() ![]() | Administrative Use Only | ||
![]() ![]() ![]() | Link ID prefix | nme | |
![]() ![]() ![]() | Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any | initiate-study-populate-exampleQR | |
![]() ![]() ![]() | ID of the Research Study FHIR Resource associated with the study Questionnaire Responses | ResearchStudyExample-sIRB | |