Introduction Electronic data capture (EDC) tools can improve data quality gathered in clinical trials and may be more cost-effective than paper forms. However, limited data is available on the adoption of EDC tools in randomized controlled trials (RCT) conducted in India. Methods We invited investigators of registered randomized controlled trials in India to an online survey. The questionnaire included questions on the use of EDC (or alternative data capture methods) and features available. An

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... DC sophistication level (ranging from 1–6) was computed from the responses obtained. Respondents were also asked about barriers to the implementation of EDC in their setting. The EDC adoption rate (EAR) was defined as the proportion of clinical trials where EDC with a sophistication level of 2 or more was used. Multivariable logistic regression was used to identify factors that predicted EDC adoption. Results Responses were received for 400 trials, with an EAR of 27.5% (95% confidence intervals : 23.4–32.1%, n = 110). The number of sites influenced EDC adoption (odds ratio : 1.26, 95% CI : 1.12–1.47, p = 0.001) on multivariable analysis. EAR did not increase over time. The key barriers identified for not using an EDC were lack of technical support (170, 63.0%) and software cost (132, 48.9%). Conclusion The survey shows a low EAR in randomized trials registered in India. The barriers identified in the survey would need systematic solutions to improve the EAR in the future.