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Purpose

Use this form to record information about the patient's death and autopsy results if applicable.

Note: Only the Date of Death is sent to CTMS if there is an indication, on the Follow-up case report form, that the patient has received further treatment. All the fields still need to be entered though.

Survival eCRF

Field Name

Description / Instructions

Format

Visit Date

The Visit Date is optional on this case report form. Hit the "Tab" key to leave it empty and move to the Date of Last Contact field.

DD-MMM-YYYY

Date of Death(m)

Enter the date the patient has died.

DD-MMM-YYYY

Cause of Death (Presumed)(m)

If the patient died without intervening therapy specific to the disease for which the patient was put on study, this section should be completed.
Categorize the cause as due to:
M - Malignant Disease
T - Toxicity from Protocol Treatment
I - Infection
O - Other (Explain)
If "Other" is checked, enter a succinct description of the presumed cause of death on the field "Explain 'Other' Presumed Cause of Death".

Use pick list.

Explain 'Other' Cause of Death (Presumed)

Enter a succinct description if option "Other" is selected as presumed cause of death. For example: Concurrent illness/MI".

24 characters

Autopsy Results Available?(m)

Select an option indicating whether the results of an autopsy are available.
Y - Yes - Autopsy done and results available.
N - No - Autopsy not done or autopsy done, but results not yet available.
U - Unknown - Do not know if an autopsy was done.
If the autopsy results are still pending, select "No" and update this CRF when the results are available.

Use pick list.

Cause of Death (Autopsy Finding)

If an autopsy was performed and a cause of death was determined at autopsy, it should be categorized according to:
M - Malignant Disease
T - Toxicity from Protocol Treatment
I - Infection
O - Other
Only one category should be checked.
If "Other" is checked, enter a succinct description of the autopsy finding cause of death on the field "Explain 'Other' Autopsy Finding Cause of Death".

Use pick list.

Explain 'Other' Cause of Death (Autopsy Finding)

If option "Other" is selected as autopsy finding cause of death, enter a succinct description, i.e., MI.

24 characters

Sites of Disease (Autopsy Finding)

Select the major sites of malignant disease involvement found at the autopsy, i.e., heart, brain, lungs, etc.

Use pick list.

Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.

Validations

Code

Description

Resolutions

SUR01

Date of Death is in the Future.

Enter a Date of Death that is earlier than or equal to the current date.

SUR02

Autopsy Results Available is set to "Yes", but Cause of Death (Autopsy Finding) is not specified.

Cause of Death (Autopsy Finding) must be provided when the Autopsy Results Available is set to "Yes".

SUR03

Autopsy Results Available is not set to "Yes" and some, or all, of the other autopsy fields have been entered.

Verify Autopsy Results Available and the other autopsy fields.

SUR04

Cause of Death (Autopsy Finding) is "Other" and Explain 'Other' Cause of Death (Autopsy Finding) is not specified.

Verify Cause of Death (Autopsy Finding) and Explain 'Other' Cause of Death (Autopsy Finding) fields.

SUR05

Explanation provided in Explain 'Other' Cause of Death (Autopsy Finding), but Cause of Death (Autopsy Finding) is not "Other".

Cause of Death (Autopsy Finding) must be 'Other' when an explanation is provided in the Explain 'Other' Cause of Death (Autopsy Finding) field.

SUR06

Cause of Death (Presumed) is "Other" and Explain 'Other' Cause of Death (Presumed) is missing.

An 'Other' Cause of Death (Presumed) requires an explanation in the Explain 'Other' Presumed Cause of Death field.

SUR07

Explanation provided in Explain 'Other' Cause of Death (Presumed), but Cause of Death (Presumed) is not "Other".

Cause of Death (Presumed) must be 'Other' when an explanation is provided in the Explain 'Other' Presumed Cause of Death field.

SUR08

Date of Death is greater than 30 days past Off Study Date.

Survival eCRF is not applicable as patient is off study.