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Code list

The Code List subtab maintains various lists incorporating information or data items that are required for filling the protocol deviation or monitor templates by the data manager, principal investigator, and others responsible for reviewing the protocol deviation or monitor templates. The list of data items is known as the code list. The code lists are prepared prior to the template creation so that while creating the templates or forms, you can use these lists. Specifically, the code lists are used by the ListBox, Radio, CheckBox, and Code list Group data types.

For example, when you are adding data to the protocol deviation template, then to add a question, if you select the ListBox data type, then the code list for the dropdown list is fetched from the Code List subtab.

Displaying code list for ListBox data type
Figure 1. Displaying code list for ListBox data type

The Code List table contains all the code lists created in the CTMS application and their details as explained in the following table.

Element

Details

Name

Represents the name of the code list.

Version

Represents the latest version of the code list.

Level #

Represents the levels of the code list. You can segregate the information in the code list up to three different levels, such as, to get addresses, the first level can include a list of states, the second can have a list of cities, and the last one can have street addresses.

Description

Represents a brief description of the code list informing readers about why the code list is created.

Display Code

Represents whether the code list includes codes for its data items.

For example, for a protocol deviation template, you may require preparing a code list for "Clinical Study Attribute Terminology". In the code list, against each data item (study attribute), the National Cancer Institute (NCI) codes must be mentioned.

In the Code List subtab, you can perform the following actions:

In this section:

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.

A person responsible for overseeing and conducting the research study at a specific investigational site or multiple sites, depending on the study's design. The role of a PI is multifaceted and involves various responsibilities, such as study oversight, protocol adherence, participant recruitment and informed consent implementation, regulatory compliance, and so on.

In the eClinical system, the Principal Investigator (PI) role that is assigned to a person who oversees the data entering and signs off subjects—gives authorized confirmation that all the entered data is valid and follows the industry standards. The responsibilities of PI can vary depending on study requirements.