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Purpose
Record information concerning the patient's off treatment date, reason and best response to treatment.
For studies without a protocol specified follow-up period, also complete the Off Study case report form entering the same Date, Reason and, if applicable, the Reason Explanation and Date of Disease Progression. Also complete the Off Study form with the same information when the Reason Off Treatment prevents the follow-up period from occurring.
Off Treatment eCRF
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Field Name | Description / Instructions | Format |
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Visit Date^(m)^ | Enter the date the form is being completed. | DD-MMM-YYYY |
Date Off Treatment^(m)^ | Enter the date when all courses have been completed (including the normal observation period) or discontinued and no further treatment courses are planned. This date will correspond to the clinic visit that would have served as the pre-course visit had the patient continued on therapy. This is the date the patient has been officially taken off treatment. | DD-MMM-YYYY |
Reason Off Treatment^(m)^ | Select an off treatment reason from one of the following reason groups: Note: Option 'C' is only available for studies without a follow-up period. 2) For patients who were evaluated for entry to the protocol and signed an informed consent form, but were not treated (never received any drugs or therapies per the protocol), select one of the following: Note: For CTMS protocols, the actual Reason sent is 'O' and the explanation text is - 'Patient Noncompliance'. N - PI Discretion: If PI made the decision. For CTMS protocols, the actual Reason sent is 'O' and the explanation text is - PI Discretion’. Note: Option 'Q' is only available for studies with a follow-up period. | Use pick list. |
Explain 'Other' Reason Off Treatment | Enter an explanation for selecting "Other" for a Reason Off Treatment. | 50 characters |
Patient Began Protocol Specified Follow-up^(m)^ | Indicate whether or not the patient began the protocol-specified follow-up period. Note: This field is only available for protocols with a specified follow-up period. | Use pick list. |
Date of Last Medication Administration (d) | Indicates date the last medication was administered. | DD-MMM-YYYY |
Best Response to Treatment^(m)^ | Select the best overall response to treatment while on protocol. | Use pick list. |
Date of Best Response | Enter the date that a Best Response of Treatment response of CR, PR, or MR was first observed, or that an SD response began. This date must be consistent with the date entered on the Course Assessment case report form(s) and with evaluations on the Extent of Disease Form. | DD-MMM-YYYY |
Date of Disease Progression | Enter the date that progression (or relapse) was first observed (i.e.: date of scan). This date is required if the Reason for Off Treatment is for Disease Progression. | DD-MMM-YYYY |
Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.
Validations
Code | Description | Resolutions |
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OTS05 | Best Response to Treatment is not 'PD/NA/NE/NP/TE' and Date of Best Response is missing. | If anything other than 'PD/NA/NE/NP/TE' is checked for Best Response to Treatment, then Date of Best Response must be entered. |
OTS07 | Best Response to Treatment is 'Disease Progression' and Date of Progression is missing. | If 'Disease Progression' is checked for Best Response to Treatment, then Date of Progression must be entered. |
OTS08 | Date of Progression is not equal to the earliest Date of Progression reported on the Course Assessment forms. | Date of Progression must be consistent with Date of Progression on Course Assessment form(s). |
OTS09 | Best Response to Treatment is not the same as the best response reported on Course Assessment forms. | Best response should be validated against responses on Course Assessment form(s). |
OTS10 | Date Off Treatment, Date of Best Response and/or Date of Progression cannot be a date in the future. | Enter a date earlier than, or equals to, the current date. |
OTS16 | Reason Off Treatment is 'Death' and Date Off Treatment is not equal to Date of Death on Survival form. | If patient died during treatment, Date Off Treatment must the same as the Date of Death on the Survival form. |
OTS17 | Reason Off Treatment is 'Death' and Date Off Treatment is not equal to Date of Study on Off Study form. | If patient died during treatment, Date Off Treatment must the same as the Date Off Study on the Off Study form. |
OTS18 | Best Response date to Treatment is not same as the Best Response reported on Course Assessment forms | Best response date should be validated against response date on Course Assessment form. |
OTS19 | Reason Off Treatment is Protocol Violation and a comment with the date the patient ended treatment does not exist. | If patient discontinued due to Protocol Violation, then reason must be stated in the Comments tab of this form. |
OTS20 | Explain 'Other' Reason provided, but Reason Off Study is not 'U', 'O' or 'K'. | Only 'Other' reasons can have an explanation. |
OTS21 | Reason Off Study is 'U', 'O' or 'K' and Explain 'Other' Reason not provided. | 'Other' reasons must have an explanation in the Explain 'Other' Reason field. |
OTS26 | For studies with protocol-specified follow-up period only: Answer to 'Patient Began Protocol-Specified Follow-up Period' is 'N - No' and there is no Off Study case report form or Off Study Reason is missing. | Please review the answer to 'Patient Began Protocol-Specified Follow-up Period' or enter an Off Study Reason. |
OTS27 | Other Reason in Off Treatment has more than 24 characters | Make Explanation for 'Other Reason' is less than 24 characters. |
OTS28 | Date of Disease Progression on Off Treatment is provided but there is no Date of Progression reported on the Course Assessment forms. | Make data consistent. |
Derivations
Code | Field Name | Description |
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OTS1002 | Date of Last Medication Administration | Indicates date the last medication was administered. |