Appendix 1. Designing a Registry/Clinical Trial in DADOS P Involves 7 Simple Steps

Appendix 1. Designing a Registry/Clinical Trial in DADOS P involves 7 simple steps.

Step 1: Define a new study. After logging into the application, the principal investigator or study coordinator (hereafter referred to as “users”) can define a new study using "add study" option displayed on the home tab. After adding a new study, they can select the study name from the home page of DADOS P to open the study-specific home page. The resultant page provides an overview of the study by displaying details such as study personnel (name of principal investigator and coordinator), data collection centers, and number of patient enrolled for each site and resultant total.

Step 2: Create a questionnaire (eCRF). Users can define a questionnaire from the "modify encounter" tab (Fig. 1). An encounter is a point in time when data are collected from the subject. They can create a new questionnaire or use a previously defined questionnaire as a template. They can define the encounter sequence based on the number of interactions with the subjects planned as a part of the study protocol. After defining the encounter sequence, they can define the question groups, individual questions, answer types, and data labels for each questionnaire.

Step 3: Add collection centers. Users can define new or modify existing data collection centers through the "collection centers" tab. It involves selecting the "new" option and adding the name of the collection center.

Step 4: Add users to the study. The principal investigator or study coordinator can then add other users and define their access rights (coordinator/interviewer) through the "add/update users" tab.

Step 5: Add source documents and regulatory files. Users can add instruction manuals, guidelines, and scales in the “source documentation” tab. Similarly, they can add IRB approval letters and consent forms in the “regulatory files” tab.

Step 6: Add subjects to the study. Finally, users can register subjects in the database using the "add/update subjects" tab (Fig. 2). The next step involves the addition of registered subjects to the clinical study/trial. If needed, subject information can be modified. After these steps, an interviewer or clinical research coordinator can collect data from a subject and directly enter it into DADOS P through the user interface (Fig. 3).

Step 7: Data extraction. Users can extract the study data into a "comma separated value" (CSV) file, which is an interoperable format (Fig. 4). This file can be uploaded to any statistical software. Users can also extract a file with variable definitions ("data dictionary”) and delete all data from the database ("master clear"). Alternatively, users can also download encounter-specific data from the "modify encounter" tab.