After logging in, a screen similar to what's shown below will be displayed. This is where all existing coding projects can be accessed, or additional coding projects can be created. No matter where you are in the system, you can return to this screen by tapping "Projects" (item 1) at the top. For all items annotated in the image, see definitions below.



1. Projects button - Returns to the main page listing all coding projects

2. Pull-out menu - Allows for switching between different accounts or databases if you belong to more than one.

3. Add - Used to add new coding projects to the table

4. Code This button - To open the corresponding project and code. Read more here.

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

6. Edit - Edit any of the items in the first five columns of the table



To Add a new project (item 3 above), continue reading...




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. 

Medical Coding Type - Select which dictionary will be used for the dataset being coded

Review Levels - Define which review levels on coded items. Provide both the applicable role and a name for the level of review. Up to two review levels can be defined, but none are necessary.

Data Source - Choose a data source (form) if the data is coming from Clinical Studio EDC. If the data is coming from an external CSV file getting imported, Follow the steps below.



Standalone File Importing


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.


The following columns are needed for event coding:


Column Name
Type
Description
PatientIdentity
String
Used to Identify an individual Patient
Date
String
Used to Create a Tx Starting Date and Visit Date
AETERM
String
MedDRA Search Term (MedDRA Only)
RecKey
String
Individual Record Key, used to insert new records or update existing records


The following columns are needed for medication coding:


Column Name
Type
Description
PatientIdentity
String
Used to Identify an individual Patient
Date
String
Used to Create a Tx Starting Date and Visit Date
CMINDC
String
WHO Indication Term (WHO Only)
CMROUTE
String
WHO Route Term (WHO Only)
CMTRT
String
WHO Search Term (WHO Only)
RecKey
String
Individual Record Key, used to insert new records or update existing records



Any other column names and data can be included and will come out in medical coding exports as well.


Important: RecKey is a unique identifier for each record. This must be unique to prevent any overwriting of records. This is also what makes updating coding lists a possibility. By adding new lines to a file, or updating existing items from a previous import, the RecKey column is how the system knows to update an item or create a new one.



To import a file (New coding projects):



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

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




Next, create a coding project to correspond to the new data set just uploaded.




The required fields are completed below. The data source should be the name of the data set file uploaded above.




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



To import a file (Updating a data file):


Once a coding project is created and partially coded, it can be updated by simply updating the file again via the Upload button. The file name must match the original. This is how the system knows which file to update on existing projects.

New records (rows) can be added to the file and existing items can be changed. The system uses the record key column (described in the table above) to determine if it should update an existing record or add a new one.

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