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Purpose
The purpose of this Case Report Form (CRF) is to capture progression free survival post-treatment. Record each off treatment long-term follow-up contact made with patient per timeline identified in the protocol.
There is no need to complete this CRF if the patient died during the treatment portion of the study. Please ensure details of patient's death are entered on the Survival CRF.
Follow-up 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 |
Progression Date After Treatment | Enter the calendar date post-treatment of the return of a disease after a period of remission. | DD-MMM-YYYY |
Basis of Diagnosis | Select the name of the technique or modality used to document the initial diagnosis of a patient:
| Use pick list. |
Date of Last Contact(m) | Enter the date the patient was last contacted. | DD-MMM-YYYY |
Type of Contact(m) | Select how the information was obtained: | Use pick list. |
Vital Status | Select one of the options below that indicates the patient's last known status. | Use pick list. |
A first relapse or PD not previously reported? | Select the text term to signify whether there was a first relapse or progression of disease.
| Use pick list. |
New Anti-cancer Therapy? | Select the text term to signify whether a patient has started a new anticancer therapy that has not been reported.
| Use pick list. |
Start Date of New Anti-cancer Therapy | Enter the calendar date on which new anticancer therapy is initiated. | DD-MMM-YYYY |
Regimen Type | Term to describe the number of agents included in therapy regimen:
| Use pick list. |
Subsequent Therapy Type | Select the text classification of the type of treatment administered to an individual after going off the treatment portion of a clinical trial:
| Use pick list. |
Received Treatment Since Last Contact?(m) | If the patient has received further treatment since the last contact, select
| Use pick list. |
Legend: (d) derived field, (m) RDC mandatory.
Validations
Code | Description | Resolutions |
---|---|---|
FLW05 | Date of Last Contact is in the future. | Enter a date earlier than, or equals to, the current date. |
FLW06 | Date of Last Contact is not within the Date Off Treatment and Date Off Study. | Date of Last Contact must fall between the Date Off Treatment and Date Off Study. |
FLW07 | Duplicate Date of Last Contact. | Date of Last Contact must be unique. |
FLW08 | Patient Status is "Unknown" and explanation is missing. | Patient Status "Unknown" requires an explanation. |
FLW09 | Explain "Unknown" Patient Status was provided, but Patient Status is not "Unknown". | Patient Status "Unknown" is required if an explanation for "Unknown" Patient Status is provided. |