Contents |
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Purpose
Use this CRF to record information about the patient's death and autopsy results, if applicable.
Survival eCRF
Field Name | Description / Instructions | Format |
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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. | 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. | 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: | 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: (m) RDC mandatory
Validations
Code | Description | Resolutions |
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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. |