Contents |
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Purpose
Record all sites of disease, even if they will not be followed for response.
Extent of Disease eCRF - Lesions Identification
Field Name | Description / Instructions | Format |
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Lesion #(m) | Select a unique number for each lesion. Once a lesion number is designated for a specific lesion, that number may not change or be used to denote a different lesion. Note: This lesion number must appear at least once on the bottom repeating group. | Use pick list. |
Prior Radiation Therapy to Lesion Site | Select a brief description for the location within the body for a lesion, organ, or treatment field intended for protocol therapy which previously received radiation treatment for the same condition. | Use pick list. |
Anatomic Site | Select the named and more specified location in the body for the site of a lesion. | Use pick list. |
Lesion Organ | Select named location with the central nervous system that is the site of a disease lesion. | Use pick list. |
Lesion Location | Select a brief description of the lesion location. | Use pick list. |
Description of Location(m) | Select from detailed spatial description of an anatomic site or location. | Use pick list. |
Side Detail | Select from specification relating to the side or laterality of an anatomic location. | Use pick list. |
Measurable / Non-Measurable(m) | Enter "M" for measurable, "N" for non-measurable, and "E" for evaluable as defined in the protocol. | Use pick list. |
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Legend: (d) derived field, (m) RDC mandatory.
Validations
Code | Description | Resolutions |
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EXT01 | Lesion Number appears more than once on the description section. | Extent of Disease Lesion Number should be unique in the description section (top repeating group). |
Extent of Disease eCRF - Lesions Measurements
Field Name | Description / Instructions | Format |
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Lesion #(m) | Select a lesion number from the pick list. Note: This lesion number must appear in the description section (top repeating group). | Use pick list. |
Course #(d) | Indicates the course number that this lesion evaluation was done in as derived from the course initiation start date. | 5 digits |
Day in Course(d) | Indicates the day since the beginning of course that this lesion evaluation was done as derived from the course initiation start date. | 5 digits |
Evaluation Date(m) | Enter the date of the evaluation (i.e.: date of CT scan). Do not enter the date of the report or when the results were received. | DD-MMM-YYYY |
How Measured(m) | Select how the lesion measurement was determined. The same method should be used to measure a specific lesion throughout the study. For example, if the measurements were determined by a chest x-ray, enter CXR. | Use pick list. |
First Longest Measurement | Enter the longest lesion measurement in centimeters.
| 6 digits and 2 decimals |
Second Longest Measurement | Enter the second longest lesion measurement in centimeters.
| 6 digits and 2 decimals |
Third Longest Measurement | Enter the third longest lesion measurement in centimeters.
| 6 digits and 2 decimals |
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Evaluation #(m) | Number each evaluation sequentially for each lesion. Use 0 for the baseline evaluation, 1 for the first evaluation, 2 for the second evaluation, etc. Note: this is the number of the set of scans done after the baseline. For example, if a new lesion was found on the third set of scans that occurred at the end of the course 4, the evaluation number should be 3. | 2 digits |
Evaluation Code | Select the status of non-measurable lesions at the time of each evaluation. | Use pick list. |
Legend: (d) derived field, (m) RDC mandatory.
Validations
EXT02 | Lesion Number in the measurement section does not have a corresponding number in the description section (Lesion Identification Page). | Verify that lesion number in the measurement section is recorded in the description section(Lesion Identification Page). |
EXT03 | Evaluation Number of a "Non-Measurable"lesion is "0" and Evaluation Code is not "B, and vice-versa. | If Evaluation Number of a "Non-Measurable"lesion is "0", Evaluation Code should be "B - Baseline". |
EXT12 | Lesion is marked as "Measurable" and longest measurement do not exist. | Enter the lesion's longest measurement. |
EXT05 | Date of Evaluation is in the future. | Enter a date that is equal to or prior to the current date. |
EXT09 | Lesion is marked as "Non-Measurable" and Evaluation Code was not provided. | Lesion is marked as "Non-Measurable" should have an Evaluation Code. |
EXT13 | The lesion has an Evaluation Code of "B - Baseline" and the Evaluation Date is not prior to Start Date of the first course. | Correct the lesion's Evaluation Date or the Evaluation Code. |
EXT14 | Evaluation Date for New lesion is prior to the Start Date of first course. | Enter a date that is equal or after the first course Start Date. |
EXT15 | Evaluation number for New lesion (with Evaluation Code 'N-New') is 0. | Enter a correct sequential number. |
EXT16 | New lesion (with Evaluation Code 'N-New') does not have the lowest evaluation number for the corresponding lesion. | Enter a correct sequential number. |
Derivations
Code | Field Name | Description |
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EXT1001 | Course # | Course number is derived based on the course initiation start dates and the extent of disease evaluation date. |
EXT1002 | Day in Course | Number of days since the beginning of the course is derived from the course initiation start date and the extent of disease evaluation date. |