Our product is a tablet based EDC system designed with a focus to educate, engage, and empower clinical trial participants and in the process improve transparency in the subject registration and data collection process.
Educating and empowering participants: Our tablet based EDC system has a work flow that starts with subject registration, subject consenting, and finally moves on to data collection using electronic case report forms. Each step needs to be completed in order to move on to the next step. Once subject registration is completed, our app automatically directs the researcher to the subject consent screen. The subject consent screen starts with a video that educates participants in very simple language about clinical trials in general, risks and benefits of participating in a clinical trial, and the rights that they are entitled to as a clinical trial participant. The video will be in language that the participant prefers. This general video is then followed by the trial specific informed consent form. We believe that this will greatly help in raising awareness about clinical trials and help potential participants make an informed decision about participating in trials. Our app enables both participants and researchers to electronically sign the consent form. This ensures that the participants sign the consent form before data can be collected from them. This will empower subjects to refuse from participating in a clinical trial and unethical collection of data from them. Once the subject signs the consent form, a pdf file of the signed form is generated with options to print it out to and /or email the same to the subject’s email ID. The researcher can only move on to the next screen when either of these actions is performed. This will ensure that the participant receives a copy of the consent form which elaborates his rights as a participant. The copy of the consent form can educate and empower the participant to take necessary actions if he/she feels that his rights as participant are being violated. During the consenting procedure, apart from signature, our app also requires collection of biometric data from the participants. This biometric verification will prevent duplication of cases and protect participants from being subjected to unethical practices such as getting vaccinated multiple times or getting lured to participate in a drug trial multiple times in exchange of monetary or other benefits.
Engaging participants: Participants will get an opportunity to create an account with our EDC system which will enable them to view their data that has been collected so far, their remaining visits, their scheduled dates, and their current status in the study. This method will create an interest in the participant regarding the study, will improve transparency regarding study visits, dates and statuses, will help them to obtain the results of diagnostic or therapeutic tests conducted on them, and will help them to verify the data collected from them. Thus, this feature in our EDC system not only engages participants but also empowers them to protect themselves against foul play.