7. Remote Monitoring

7.1 eConsent/Remote Consent 

The use of eConsent has become acceptable in China in the last 4 years and is allowed according to the new guidelines.

7.2 eSignature (including any requirement for a countersignature (e.g. PI, witness, etc.)

Since COVID-19, the use of electronic signatures in trials has become increasingly accepted.

Under Chinese law, a written signature is not necessarily required for a valid contract – contracts are generally valid if legally competent parties reach an agreement, whether they agree verbally, electronically, or in a physical paper document (i.e., Contract Law, E-Signature Law). The E-Signature Law specifically confirms that contracts can be electronically signed. To prove a valid contract, parties have to present sufficient evidence in court that the contract was formed electronically. Leading digital transaction management solutions can provide electronic records that are admissible in evidence under Chinese law, to support the existence, authenticity, and valid acceptance of a contract.

https://www.docusign.com.au/how-it-works/legality/global/china

Where consent is made remotely, the authenticity of the person signing the consent needs to be assured. This can be either through a counter signature or a video link to the person making the signature. Thus, the counter signature is only required to support the authenticity of the person signing.

7.3 Remote Assessment

Remote assessments are permitted according to the Technical Guiding Principles for the Implementation of Patient-Centered Drug Clinical Trials (English Translation). See Section 5.6. 

7.4 Electronic Patient Reported Outcome (ePro) 

ePro is considered acceptable according to the Technical Guiding Principles for the Implementation of Patient-Centered Drug Clinical Trials (English Translation). Sponsors must ensure the reliability of data capture and that the process can be used reliably by users with different levels of experience with electronic systems. The electronic system must meet the same standards as a paper-based system. 

7.5 HHC – Home Nursing 

Home nursing is acceptable. Specific practices are subject to RA and ethics approval. 

Technical Guiding Principles for the Implementation of Patient-Centered Drug Clinical Trials (English Translation)

7.6 HHC – Home Lab Collection

Home lab collection is acceptable. Specific practices are subject to RA and ethics approval. 

Technical Guiding Principles for the Implementation of Patient-Centered Drug Clinical Trials (English Translation)

7.7 Remote Monitoring

Remote monitoring is acceptable according to the Technical Guiding Principles for the Implementation of Patient-Centered Drug Clinical Trials (English Translation).

The acceptability of remote monitoring should be assessed using a risk-based approach based on the nature of the disease, the method of treatment, and the ease of monitoring. Patient safety and data reliability must be assured. 

7.8 Telemedicine

The use of telemedicine is acceptable according to the Technical Guiding Principles for the Implementation of Patient-Centered Drug Clinical Trials (English Translation). The specific details of the approach to be undertaken are subject to RA and EC approval. 

7.9 Wearables

The use of wearables is acceptable according to the Technical Guiding Principles for the Implementation of Patient-Centered Drug Clinical Trials (English Translation). The specific details of how the device will be worn, and managed are subject to RA and EC approval.