7. Decentralized Clinical Trials

7.1 Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)?

There are no regulations preventing the conduct of a DCT.

7.2 Is there any specific regulation/guidance on the use of DCT elements within a clinical trial?

There are no specific guidelines on the use of DCT elements.

7.3 What is the overall acceptability of DCT elements by the regulatory authorities and Ethics Committees?

DCT initiatives are not prevented but are subject to individual approval by the ethics committee on a case-by-case basis.

7.4 Has a fully virtual trial (DCT) been conducted in the country yet? If so, please provide an example including the registration number and any link to it, whether COVID/non-COVID trials.

Intelligence suggests that DCTs have been conducted in India, however, no specific examples could be identified.

7.5 Are there any non-regulatory DCT initiatives in the country, such as where the investigator sites and local CROs founded an alliance?

No. There are no local alliances for DCTs. However, in 2022, the Indian Society of Clinical Research issued a position paper on DCTs. 

7.6 Are there any general considerations when using DCT elements in a study?

In principle, there is nothing to prevent the implementation of a DCT model in India.

7.7 Considerations/Requirements for the Use of eConsent/Remote Consent

eConsent is not permitted. Consent must be provided in writing or using a thumbprint if the participant cannot sign.

7.8 Considerations/Requirements for the Use of eSignatures

eSignatures are legally valid and admissible in a court of law. The Information Technology Act, 2008 (IT Act), confirms that signed agreements cannot be denied enforceability merely because they are concluded electronically. To prove a valid contract, parties sometimes must present evidence in court. Under Section 65B of the Evidence Act (1872), eSignature solutions can be used to give electronic records that are admissible as evidence to support contracts in court.

7.9 Considerations/Requirements for Electronic Patient Reported Outcome (ePRO)

There is no specific guidance on this topic.

7.10 Considerations/Requirements for Home Health Care (HHC) - Home Nursing

There is no specific guidance on this subject. In general, there is an increasing trend towards home healthcare in India. The intended approach would be subject to ethics approval.

7.11 Considerations/Requirements for HHC - Home Lab Collection

There is no specific guidance on this topic.

7.12 Considerations/Requirements for Direct-to-Patient Study Product Delivery

There is no formal regulation around this subject. However, as per this article, DTP services were implemented during the COVID-19 pandemic and are expected to continue.

7.13 Considerations/Requirements for the Use of Telemedicine

There is no specific guidance on this topic.

7.14 Considerations/Requirements for the Use of Wearables

There is no specific guidance on this topic.

7.15 Considerations/Requirements for Remote Assessment/Monitoring

There is no specific guidance on remote assessment. However, this was used during the COVID-19 pandemic in order for trials to continue and, whilst there are still some barriers to implementation, there has been continued demand for these services.

7.16 Considerations/Requirements for Digital Health Technologies (such as Platforms)

There is no specific guidance around the use of digital health technology platforms.