LinkId Text Definition Answer nme-populate-exampleQR QuestionnaireResponse nme1 Research Study nme1.1 Study Title Study of Drug A for arthritis nme1.3 IRB Protocol Number PRO098765 nme1.4 Status Temporary Codes nochange: No change in research activities nme7 Organization/Site nme7.1 Where Adverse Non-Medical Event Occurred nme7.1.8 Did the Adverse Non-Medical Event occur at the lead principal investigator site? expandedYes-NoIndicator N: No nme7.1.11 Did the Adverse Non-Medical Event occur at one of the relying sites? expandedYes-NoIndicator Y: Yes ExternalDataFor_nme7.1.9 External Data For linkId nme7.1.9 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 nme7.1.1 Name of organization/site where the Adverse Non-Medical Event occurred Central Campus Test University nme7.1.2 City Central nme7.1.3 State MI nme7.1.4 Country United States nme7.2 Responsibility for Adverse Non-Medical Event Reporting nme7.2.8 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 nme7.2.1 Name of organization/site which is recording the Adverse Non-Medical Event Sample University Medical Center nme7.2.2 City Sample City nme7.2.3 State NC nme7.2.4 Country United States nme8 Site Principal Investigator for the site where Adverse Non-Medical Event occurred nme8.1 First Name Maria nme8.4 Last Name Smith nme8.6 Degree(s) PhD nme8.2 Phone 8901231234 nme8.3 Email maria.smith@CCTU.med.edu nme3 Report nme3.1 Report Date 2022-02-27 nme3.2 Report Status Temporary Codes init: Initial nme3.3 Select at least one of the following criteria: nme3.3.4 New information resulted in unexpected change in risks of the research true nme3.3.5 New or increased risk nme3.3.5.1 Date: 2022-02-27 nme3.3.5.2 Date discovered: 2022-02-26 nme3.3.5.3 Description: [answer] nme3.3.6 Unanticipated Problem Involving Risk to Participants or Others true nme3.3.7 Unanticipated Problem nme3.3.7.1 Event date: 2022-02-26 nme3.3.7.2 Date event became aware to study team: 2022-02-27 nme3.3.7.3 Event Summary: [answer] nme3.3.7.4 Was this event Unexpected? expandedYes-NoIndicator Y: Yes nme3.3.7.5 If yes, please explain: [answer] nme3.3.7.6 Was this event Related or Possibly Related to participation in the research? expandedYes-NoIndicator Y: Yes nme3.3.7.7 If yes, please explain: [answer] nme3.3.7.8 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 nme3.3.7.9 If yes, please explain: [answer] nme3.3.10 A breach of Confidentiality false nme3.3.14 Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team true nme3.3.15 Participant Complaint nme3.3.15.1 Complaint Date: 2022-02-27 nme3.3.15.2 Date received: 2022-02-27 nme3.3.15.3 Description: [answer] nme4 Reporting nme4.1 Was the Sponsor notified? expandedYes-NoIndicator Y: Yes nme4.2 Notification date: 2022-02-27 nme4.3 Was the IRB notified? expandedYes-NoIndicator Y: Yes nme4.4 Notification date: 2022-02-27 nme4.5 Were any Other Parties notified? expandedYes-NoIndicator Y: Yes nme4.6 List other notified parties [answer] nme5 Corrective and Preventative Action Plan nme5.1 Was a Root Cause analysis performed? Temporary Codes pending: Pending - Currently under development nme5.2b If pending, describe status and interim findings, if any: [answer] nme5.3 Was Corrective Action implemented? Temporary Codes pending: Pending - Currently under development nme5.4 If Corrective Action was implemented or is pending, provide a summary: [answer] nme5.5 Was Preventitive Action implemented? Temporary Codes completed: Done, performed or completed nme5.6 If Preventitive Action was implemented or is pending, provide a summary: [answer] nme6 Study Protocol and Informed Consent nme6.1a Are changes required to the Study Protocol as a result of this report? expandedYes-NoIndicator Y: Yes nme6.3a Are changes required to the Informed Consent as a result of this report? expandedYes-NoIndicator Y: Yes nme6.5 Are notifications or re-consenting of participants required as a result of changes in Study Protocol or Informed Consent? expandedYes-NoIndicator Y: Yes nme6.6 If yes, detail how the notification and/or re-consent will occur: [answer] nme11 Optional Attachments nme11.1 Describe the file that is being attached (optional) [answer] nme11.2 Attachment No display for Attachment ADMIN00 Administrative Use Only ADMIN01 Link ID prefix nme ADMIN02 Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any initiate-study-populate-exampleQR ADMIN03 ID of the Research Study FHIR Resource associated with the study Questionnaire Responses ResearchStudyExample-sIRB Documentation for this format
Where Adverse Non-Medical Event Occurred
Did the Adverse Non-Medical Event occur at the lead principal investigator site?
Did the Adverse Non-Medical Event occur at one of the relying sites?
Sample University Medical Center | | Jane Doe, MD | Sample City, NC
Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA
Central Campus Test University | | Maria Smith, PhD | Central, MI
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.
Name of organization/site where the Adverse Non-Medical Event occurred
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?
Name of organization/site which is recording the Adverse Non-Medical Event
Site Principal Investigator for the site where Adverse Non-Medical Event occurred
Select at least one of the following criteria:
New information resulted in unexpected change in risks of the research
Unanticipated Problem Involving Risk to Participants or Others
Was this event Related or Possibly Related to participation in the research?
Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known?
Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team
If pending, describe status and interim findings, if any:
If Corrective Action was implemented or is pending, provide a summary:
If Preventitive Action was implemented or is pending, provide a summary:
Are changes required to the Study Protocol as a result of this report?
Are changes required to the Informed Consent as a result of this report?
Are notifications or re-consenting of participants required as a result of changes in Study Protocol or Informed Consent?
If yes, detail how the notification and/or re-consent will occur:
Describe the file that is being attached (optional)
Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
ID of the Research Study FHIR Resource associated with the study Questionnaire Responses