LinkId Text Definition Answer medical-ae-populate-exampleQR QuestionnaireResponse mae1 Research Study mae1.1 Study Title Study of Drug A for arthritis mae1.2 IRB Protocol Number PRO098765 mae1.3 Study Type Temporary Codes INT: Interventional mae1.4 Does this protocol require an FDA exemption? expandedYes-NoIndicator Y: Yes mae1.5 Is an IND or IDE being used in this study? expandedYes-NoIndicator Y: Yes mae4 Organization/Site mae4.1 Where Adverse Medical Event Occurred mae4.1.7 Did the Adverse Medical Event occur at the lead principal investigator site? expandedYes-NoIndicator N: No ExternalDataFor_mae4.1.1 External Data For linkId mae4.1.1 mae4.1.1 If the Adverse Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the the relying institution and relying site principal investigator details below. [not stated] : Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA mae4.1.2 Name of organization/site where the event occurred Test Example University mae4.7 Site Principal Investigator mae4.7.1 First Name Xi-Yang mae4.7.2 Last Name Lee mae4.7.5 Suffix Jr. mae4.7.6 Degree(s) MD, PhD mae4.7.3 Phone 6781233456 mae4.7.4 Email XiYangLee@teu.med.edu mae4.9 Responsibility for Adverse Medical Event Reporting mae4.9.1 If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be recording the Adverse Non-Medical Event? expandedYes-NoIndicator Y: Yes mae4.9.2 Name of organization/site which is recording the Adverse Medical event Sample University Medical Center mae3 Primary Contact mae3.1 First Name Jane mae3.2 Last Name Doe mae3.3 Phone 567-123-1234 mae3.4 Email drjanedoe@sampleuniversity.edu mae5 Participant Information mae5.1 Patient ID 12345 mae5.2 Age 58 mae5.3 Birth Sex administrativeSex M: Male mae5.4 Weight 245 [lb] mae5.5 Height 67 [in] mae5.6 Ethnicity Ethnicity 2186-5: Not Hispanic or Latino mae5.7 Race Race 2106-3: White mae5.8 Which Arm/Cohort/treatment group was the participant assigned to (if known)? unknown mae5.9 Participant dosed or received study agent expandedYes-NoIndicator NI: No Information mae5.11 Were there any Protocol Deviations/Violations/Exceptions for this participant? expandedYes-NoIndicator N: No mae6 Adverse Medical Event Information mae6.1 Submission Type Temporary Codes INITIAL: Initial mae6.2 Start Date 2021-11-05 mae6.3 Reported Date 2021-11-06 mae6.4 Recorded Date 2021-11-06 mae6.10 Is the Adverse Medical Event Serious? AdverseEventSeriousness serious: Serious mae6.9 Severity AdverseEventSeverity mild: Mild mae6.40 Narrative of the Adverse Event: Blood clot developed in right leg after several days of inactivity. Participant experienced swelling and pain. mae6.5 Medical Description of Adverse Event Deep Vein Thrombosis mae6.6 Is the Adverse Medical event still ongoing? expandedYes-NoIndicator N: No mae6.7 Stop Date 2021-11-05 mae6.8 Was the event expected? eventExpected N: No mae6.11 Seriousness mae6.11.1 Seriousness Temporary Codes ResultsInHospitalization: Requires or prolongs inpatient hospitalization mae6.12 What is the date Adverse Medical Event became serious? 2021-11-05 mae6.13 Outcome of Adverse Medical Event Temporary Codes RCVRED: recovered/resolved mae6.15 Relationship of Adverse Medical Event to Study Intervention AdverseEventCausalityAssessment possible: Possible mae6.16 Rationale for relationship with study intervention Patient was inactive for several days which might have been the cause. mae6.23 Action Taken mae6.23.1 Action Taken Regarding Study Intervention actionTakenInResponseToTheEvent WT: Product withdrawn temporarily mae6.24 If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate? expandedYes-NoIndicator Y: Yes mae6.25 If study intervention was restarted (rechallenge) did AE recur? expandedYes-NoIndicator N: No mae6.50 SAE Concomitant Medications, Treatments/Procedures and Tests mae6.50.26 Did the participant receive any relevant concomitant medications in response to the SAE? expandedYes-NoIndicator Y: Yes mae6.50.28 SAE Concomitant Medications mae6.50.28.1 Medication Name warfarin mae6.50.28.2 Indication anticoagulant mae6.50.28.3 Start Date 2021-11-05 mae6.50.28.4 Stop Date 2022-02-04 mae6.50.28.5 Ongoing expandedYes-NoIndicator N: No mae6.50.29 Did the participant receive any treatments/procedures in response to the SAE? expandedYes-NoIndicator N: No mae6.50.37 Did the participant receive relevant laboratory or diagnostic tests in response to the SAE? expandedYes-NoIndicator Y: Yes mae6.50.38 SAE Laboratory or Diagnostic Tests mae6.50.38.1 Lab/Diagnostic Test ultrasound mae6.50.38.2 Date 2021-11-05 mae6.50.38.3 Result positive mae6.50.38.6 Comments blood clot noted mae11 Optional Attachments mae11.1 Describe the file that is being attached (optional) Treatment instructions received from sponsor regarding this AE. mae11.2 Attachment No display for Attachment ADMIN00 Administrative Use Only ADMIN01 Link ID prefix mae 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
Does this protocol require an FDA exemption?
Is an IND or IDE being used in this study?
Did the Adverse Medical Event occur at the lead principal investigator site?
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 Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the the relying institution and relying site principal investigator details below.
Name of organization/site where the event occurred
Responsibility for Adverse Medical Event Reporting
If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be recording the Adverse Non-Medical Event?
Name of organization/site which is recording the Adverse Medical event
Which Arm/Cohort/treatment group was the participant assigned to (if known)?
Participant dosed or received study agent
Were there any Protocol Deviations/Violations/Exceptions for this participant?
Blood clot developed in right leg after several days of inactivity. Participant experienced swelling and pain.
Is the Adverse Medical event still ongoing?
Requires or prolongs inpatient hospitalization
What is the date Adverse Medical Event became serious?
Relationship of Adverse Medical Event to Study Intervention
Rationale for relationship with study intervention
Patient was inactive for several days which might have been the cause.
Action Taken Regarding Study Intervention
If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate?
If study intervention was restarted (rechallenge) did AE recur?
SAE Concomitant Medications, Treatments/Procedures and Tests
Did the participant receive any relevant concomitant medications in response to the SAE?
Did the participant receive any treatments/procedures in response to the SAE?
Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?
Describe the file that is being attached (optional)
Treatment instructions received from sponsor regarding this AE.
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