Contents |
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Purpose
Record each follow-up contact as identified in the protocol.
There is no need to complete this Case Report Form if the patient died during the treatment portion of the study. Survival CRF still needs to be completed.
Follow-up 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 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. |
Received Treatment Since Last Contact?(m) | If the patient has received further treatment since the last contact, select Note: When answering 'Yes' and the patient has died during the follow-up period, only the Date of Death, entered on the Survival case report form, is sent to CTMS. Cause of Death and Autopsy information are not sent. | Use pick list. |
Patient Status(m) | Select one of the options below that indicates the patient's last known status. If the patient has died, enter the date in the Date of Death field. If status is unknown, enter some explanation on the field labeled "Unknown (explain)". | Use pick list. |
Explain 'Unknown' Patient Status | If Patient Status is unknown, enter some explanation here. Include what attempts were made and how many attempts where made in order to obtain the patient's status (i.e.: no response to 5 messages left). | 24 characters |
Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.
Validations
Code | Description | Resolutions |
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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. |