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Record the results of the procedures that are performed as part of the protocol. All laboratory results are to be recorded on the appropriate lab CRF. All procedures that are done as a result of an adverse event are to be recorded on the concomitant measures CRF
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 field. | DD-MMM-YYYY |
Course #(d) | Indicates the course number the procedure is related to based on their date and time. | 5 digits |
Day in Course(d) | Indicates the day since the beginning of course the procedure is related to based on their date and time. | 5 digits |
Date(m) | Enter the date that the procedure was done, not the date it was interpreted by the radiologist or investigator. | DD-MMM-YYYY |
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Procedure(m) | Select the procedure from the pick list. EKG Electrocardiogram | Use pick list. |
Body Site(m) | Select the body site from the pick list. | Use pick list. |
Abnormal Result?(m) | Select whether the finding results for the particular procedure / body site were either: | Use pick list. |
Findings | If abnormal, enter as summary of the abnormal findings. | 128 characters 200 characters for non-CTEP sponsored studies. |
Legend: (d) derived field, (m) RDC mandatory. |
Code | Description | Resolutions |
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LBLL01 | Procedure date is in the future. | Enter a date that is equal to or prior to the current date. |
LBLL02, | Findings were entered and Abnormal is not "A-Abnormal" or Abnormal is "A-Abnormal" and no brief description was entered in the Findings. | Abnormal Findings must have a brief description. |
Code | Field Name | Description |
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LL1001 | Course # | Course number is derived based on the course initiation start dates and the procedure date. |
LL1002 | Day in Course | Number of days since the beginning of the course is derived from the course initiation start date and the procedure date. |