DEATH
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period
Visit XYZ
Upload the source documents for all data requested in this eCRF (e.g., labs, study results) as well as
the admission History and Physical Examination findings and the Discharge Summary.
A. Date of death:
Day
B.
C.
Death reported
by:
(all that
apply)
Was an autopsy
performed?
Month
Year
Hrs:Mins
(00:00-23:59)
Investigator
Primary Care Physician
Treating Physician
Medical Examiner
Other, Specify ____________________________
[Y]
Yes [N] No [NK] Not Known
If Yes submit report.
COURSE OF DEATH
Was the death witnessed?
[Y]
Yes [N]
No [NK]
Not Known
[Y]
Yes [N]
No [NK]
Not Known
If the death was un-witnessed, was the subject seen or
heard alive within 24 hours of death?
[Y]
Yes [N]
No [NK]
Not Known
Did the subject have a condition that made him/her
terminal or pre-terminal? *(terminal: death expected within
less than one month; pre-terminal: death expected in 1 to 6
months)
[Y]
Yes [N]
No
[NK]
Not Known
[Y]
[Y]
[Y]
Yes [N]
Yes [N]
Yes [N]
No
No
No
[NK]
[NK]
[NK]
Not Known
Not Known
Not Known
If Yes, was it witnessed by medical personnel?
Where did death occur (e.g. hospital, home, and other)?
Hospital?
Home?
Other?
Page 1 of 4
DEATH
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period
Visit XYZ
PRIMARY CAUSE OF DEATH (only one )
Was primary cause of death Cardiovascular ?
[Y]
If Yes, see Cardiovascular Causes and specify if able:
If No, see Non-Cardiovascular Causes and specify if able:
Yes [N]
No [NK]
Not Known
Cardiovascular Causes
Myocardial Infarction
Sudden Cardiac Death
Heart Failure
Stroke
Cardiovascular Procedures (including cardiovascular surgery)
If Yes, complete Revascularization CRF
Cardiovascular Hemorrhage
Other Cardiovascular Causes – Specify:_________________________________________________________
Non-cardiovascular Causes
Pulmonary
Renal
Gastrointestinal
Hepatobiliary
Pancreatic
Infection (includes sepsis)
Non-infectious (e.g., systemic inflammatory response syndrome [SIRS])
*may include anaphylaxis (e.g., peanut allergy)
Hemorrhage that is neither cardiovascular bleeding or a stroke
Non-CV procedure or surgery
Trauma
Suicide
Page 2 of 4
DEATH
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period
Visit XYZ
Non-prescription drug reaction or overdose
Prescription drug reaction or overdose
*may include anaphylaxis
Neurological (non-cardiovascular)
Cancer (Malignancy)
If Yes, check only one below if known
Disease under study * Only applicable/permitted for oncology studies
Other cancer
Other non-CV, specify:
______________________________________________________________________________
SECONDARY Or CONTRIBUTORY CAUSE(s) OF DEATH
Were there any secondary / contributory cause(s)
[Y]
of death that were Cardiovascular ?
If Yes, see Cardiovascular Causes and specify if able:
If No, see Non-Cardiovascular Causes and specify if able:
Yes [N]
No [NK]
Not Known
Cardiovascular Causes
Myocardial Infarction
Complete MI/Unstable Angina eCRF.
Sudden Cardiac Death
Complete Cardiac Arrhythmia eCRF.
Heart Failure
Complete Heart Failure eCRF.
Stroke
Complete Cerebrovascular Events Stroke/TIA eCRF.
Cardiovascular Procedures (including cardiovascular surgery)
If Yes, complete Revascularization CRF
Cardiovascular Hemorrhage
Haemorrhage – specify organ: __________________________________________________________________
Other Cardiovascular Causes – Specify:_________________________________________________________
Page 3 of 4
DEATH
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period
Visit XYZ
Non-cardiovascular Causes
Pulmonary
Renal
Gastrointestinal
Hepatobiliary
Pancreatic
Infection (include sepsis)
Non-infectious (e.g., systemic inflammatory response syndrome [SIRS])
*may include anaphylaxis (e.g., peanut allergy)
Hemorrhage that is neither cardiovascular bleeding or a stroke
Non-CV procedure or surgery
Trauma
Suicide
Non-prescription drug reaction or overdose
*may include anaphylaxis
Prescription drug reaction or overdose
*may include anaphylaxis
Neurological (non-cardiovascular)
Cancer (Malignancy)
If Yes, check only one below if known
Disease under study * Only applicable/permitted for oncology studies
Other cancer
Sepsis Infection (includes sepsis)
Trauma
Suicide
Other Non-cardiovascular –specify:
______________________________________________________________________________
Page 4 of 4