Lab Forms

Lab forms are specified CRFs that have been created with a special lab form design to allow for data entry of a set of analytes. Examples of forms that may be designed as lab forms are Blood Chemistry Lab Panel, Hematology Lab Panel, Renal Assessment (CrCl), etc. Analytes to be completed on a lab form are selected at time of CRF design. Normal ranges are entered by the Study Administrator and are based on the Lab Location and normal ranges provided by the site at the beginning of the study.

Data entry on a lab form follows slightly different rules for respective data points. To enter data on a Lab form follow the steps below.

Collection Date and Lab Location

1. Locate your Lab Form in the Casebook Schedule.
2. Click the Form to open it.
3. Enter the Collection Date and Time. These fields are required to be entered.
4. Select a Lab Location. This field is required to be entered.
5. Veeva EDC will fill in the subject’s Age and Sex from the Demographics form. If one or both of these fields is not completed on the Demographics form these fields will remain blank on the lab form and no lab results will be able to be entered. Navigate back to the Demographics and/or Informed Consent form and ensure the Sex field, Date of birth field, and the Informed Consent field are completed and the forms submitted. You can then navigate back to the lab form and these fields should be populated, or you can click Edit Form to refresh the fields, then re-Submit the form.
   
   

Lab Panel

1. Enter results for each analyte listed in the Lab Result column. If the study design allows, the Lab Result may be preceded by a symbol to indicate less than, greater than, less than or equal to, or greater than or equal to.
   1. The actual lab result should be entered in the blank box; each analyte result has been formatted to allow for a specified limit of digits, which may or may not include decimal points. If alphabetical or special characters (other than a decimal point) are entered in the field, an automated error message will appear. In addition, if the data entry exceeds the number of digits allowed an automated error message will appear. The error must be corrected in order for the form to be submitted.
   2. Enter the unit of measure in the drop down next to the result. The unit field defaults to the standard unit of measure, and if no selection is made the default unit will populate.
2. If lab normal ranges have been entered for the selected lab, Veeva EDC automatically flags results that are above or below the normal range as “High” or “Low”.
   1. If a unit of measure other than the standard is selected, the system will automatically calculate the result based on the standard unit of measure, which may result in high or low flags.
      
3. If the study design allows, if a result is flagged as high or low you must indicate whether the out-of-range result is Clinically Significant.
   
   

%Overriding Lab Normal Ranges
If lab normal ranges are not accurate, ensure that the correct lab normal ranges have been sent to the study inbox (ACCELERATE@nmdp.org) so the updated ranges can be entered into the system. If you need to do data entry prior to the ranges being updated, you can override the current lab normal ranges by clicking Edit (pencil icon) in the Normal Override column and enter new Normal Ranges. A Reason for Override must be entered in order for the new normal range to be saved in the EDC.

Lab Tests Not Performed
If an entire set of analytes was not completed for a specific time point, you can check the box next to “Lab Tests Not Performed” in the Collection Date and Lab Location section and enter a reason code. This will disable all fields on the form and move the form into an “Intentionally Left Blank” status. No error messages will appear for any blank fields.

If this box was checked in error, or subsequent information indicates lab tests were completed, you can remove the “Lab Tests Not Performed” check by editting the form and completing data entry.

!Selecting Lab Tests Not Performed should only be used sparingly when there is a valid reason for the lab test or specimen collection not being performed.

At no time should this feature be used to circumvent normal data entry procedures for lab tests and analytes that were actually completed.

Missing Results
If one or more analyte was not completed for a specific time point, check the box under the “Missing Results” column in the Lab Panel section. A reason code is required to be entered. The Lab Result column will show the reason code entered rather than a lab result.

!Selecting Missing Result for an analyte should be used sparingly, in instances where an analyte was not resulted in the lab report (e.g., sample was insufficient for analysis – insufficient volume, low quality or improper container, hemolysis, clotting, etc.).

At no time should this feature be used to circumvent normal data entry procedures for lab tests and analytes that were actually completed.

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