The Lab Range Manager is used to setup lab sites and their corresponding ranges based on the various dependencies that may exist in the study.
It can be found under the Study menu:
Once open, use the form highlighted below to populate the table above it with the various lab sites that will apply across the entire study. Lab sites will be associated with study sites in the next step. There is no limit to the number of lab sites you can create.
Note, labs are essentially entities similar to sites that can be utilized across various studies within the same host account. If making changes to existing labs, be sure those labs are not part of another study on the account. If they are, making a change to it would affect both studies.
Now its time to create the various lab ranges for each lab site by selecting the link highlighted below:
This is where you will map each column from the source file (must be csv format) to the system.
First, add the number of columns that exist in the source file in sequential order. The only rules of inclusion are that the lab name must be the first column, and two of the columns should be effective start and stop dates. It is important to include ALL columns of the source file - even if they will not be used. In such cases, the column type will simply be labeled as "Filler (Ignore)".
After adding the number of rows needed, its time to map each row to a column in the source file.
To do this, select the Edit link on each row, provide a name (does not need to match source file), and select what its function is based on the list of options shown below. At minimum, required items will be:
- Lab Test Name
- Protocol min and max
- Lab Unit Code
- Effective date range
Note: Currently the Lab min/max options are not functional in the system. Please use only the Protocol min/max to map the lab ranges.
Notice in the list of options under Column Type, any external variables/lab range stratifications are at the bottom of the list. If you need one that is not listed, create an external variable first.
The images below show both an example source file and how each of the items from the column type apply to each one.
If a test is present in the lookup table, it must have values for any external variables included. In other words, if gender is a variable, it must not be left blank in the lookup table. Additionally, if a subject is entered in the study without gender indicated, the system will not run the checks.
The column names you enter for each item do not need to match the column name in the source file. The order is how the system determines the columns.
Any range dependencies, like the gender and age shown above, must be set as external variables in the study.
Notice the Age is two columns in the source file, but only accounted for in row 3 of the mapping. This is because for any number/value dependencies like age or weight or BMI, for example, the system assumes it must be a range where the low range column is first and the high range column is second.
The gender can use "M" or "F" for Male and Female respectively. The system assumes "B" is for Both, but Both does not need to be an actual choice in the study.
Any columns that need to be skipped in the source file should be set as "Fillers".
The most important items to be sure are mapped are:
- Lab Test Name - Must match the lab test names used in the study CRF. If a lab test is in the CRF but not on this file, it will cause a saving error for users doing data entry. If checks will not be done on certain lab test, its okay to still include them in the file, but do not enter any values for the min/max.
- Protocol Min Value
- Protocol Max Value
- Lab Unit Code
All dependencies (e.g. Age, Race, Weight, etc) or the effective start/end dates of the ranges are optional. Currently the Lab min/max values are not functional, but will be coming soon for added capability.
When all items are mapped, select the link on the right side of the page that is highlighted in the image above.
Next, return to the Lab Manager page to import the source file. If the mapping saved correctly, there will be an option to Import File:
Now upload the CSV file and ensure it is read successfully. The table will display on the page if the file is read successfully.
After one lab site is setup with mapping, if all other lab sites follow the same source file format, the mapping can easily be copied to the next site:
Important Note: Labs exist at the host/account level. This means if labs are set up in one study, anything done with them on a separate study will affect any other study. The reason for this is that sites are tied to sites, and sites exist at the host level before they are attributed to studies which they are part of.
Next, read about how to associate the study sites with appropriate lab sites.