A randomized clinical trial requires the creation of a randomization list. It is a document that assigns each patient included in the study a randomization number associated with a treatment group defined according to the study design. At least these two elements are required to create a randomization list. Other elements such as stratification variable and randomization code may be added depending on the study design. Our objective is to create a reusable program, using a random seed to ensure reproducibility and allow the list to be extended during the study without changing existing assignments. All randomization lists must be validated. This is why we aim to standardize validation by checking the balance of groups by stratum and the uniqueness of codes and numbers. This application combines list generation and validation, saving time and simplifying implementation.

Shiny is an R software package that allows you to create user interfaces directly from the R language. It offers the possibility of designing dynamic applications capable of automatically adapting the expected results and visualizations according to the parameters entered, thus making them more accessible to use. Shiny applications are grouped together in a single file called app.R. To generate a randomization list, the user must choose several parameters. In accordance with quality control, a test randomization list is generated in addition to the final list. To verify a randomization list, the parameters to be checked are the even distribution of groups within each stratum and the uniqueness of the randomization code required for its implementation in the eCRF.

Our application is presented in a two-part multi-window format. The left side layout consists of parameters that the user must fill in : number of patients, the number and identification of strata, block size, and number and identification of groups. The main part presents several results tabs: randomization lists and their respective verification. The verified randomization lists produced containing columns headed: stratum value, randomization sequence number, treatment code, randomization code, and actual treatment assigned. These lists can be downloaded in CSV format. Randomization parameters, along with the checks and verifications performed, are also available for download in HTML format.

RALI-RCT is a new validated tool that allows the creation and validation of randomization lists without coding, within a structured and intuitive interface