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Instructions

After logging in on to TrialKit Coder website directly or accessing it within TrialKit, a screen similar to what's shown below will be displayed. This is where coding projects can be created on existing datasets, or all existing coding projects can be accessed for a given study/database.

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Note

If coding is being done from a study collecting data within TrialKit, those studies need to be setup to support coding. This article assumes that step has been done. For info on the study being setup correctly, read this article: https://crucialdatasolutions.atlassian.net/servicedesk/customer/kb/view/498204675 click here.

See the annotated image and descriptions below.

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  1. Table of coding projects - This lists the current coding projects which have been created. Each project is tied to a specific dataset which can be updated over time.

  2. Add New Project - Use this to create a new coding project. This only needs to be done once for each datasource being coded. If updating an existing datasource, the upload option will be used with the same data source name (file name).

  3. Upload CSV - Use this to upload data source files to code. After uploading, a new data source, a project must be created to perform the coding on it. Read more at the bottom of this article.

    Note, This option only displays for standalone coding. Live TrialKit EDC studies will not have this option, since the data source comes in automatically from the study in EDC.

  4. Code This - Opens the corresponding project for coding. Read more here. This link will not run any coding on the terms.

  5. Dashboard - Reports on metrics regarding the coding project. Read more here.

  6. Edit/Delete - Edit the name or workflow levels of the coding project, or Delete the entire dataset. WARNING: Deleting will delete the coding project and all underlying data. This will not be available for coding projects tied to a live TrialKit EDC study.

  7. User preferences (change password and logout) and options to switch to a different study or database.

To Add

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A New Project (#2):

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Configuration Name - Name the project. If doing standalone CSV importing (described below), be sure to first upload the file before doing this step. If using the mobile app, be sure the name of the configuration matches the name of the CSV file, without the file extension on the end. 

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Data Source - Choose a data source for the coding project. This will be either a form from TrialKit EDC or an imported data file (described below).

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Standalone File Importing (not applicable to studies being conducted in TrialKit EDC)

To prepare a CSV file for importing and coding the terms, a few minor requirements exist. Any number of additional columns (data points) can be imported to assist with the coding process, but there are basic columns needed for the auto-coder to work and for the system to be able to differentiate records when adding new ones or updating records over time.

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Upload the file containing columns described above in the table, depending on if coding to MedDRA or WHO Drug.

Once The the Upload button is selected, a message will display indicating successful upload. The window can then be closed.

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After saving, the table will populate with the new coding project, which can now be coded.

To

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Import A File (Updating

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A Data File)

Once a coding project is created and being worked on, it can be updated over time by updating the file again via the Upload button as described above. The file name must match the original. This is how the system knows which file to update on existing projects.

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Existing coding will not be affected unless the verbatim term changes. In that case, the coding details no longer apply and are cleared.

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