Managing Studies in China

  • Published by Viedoc System 2024-03-19
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Introduction

When starting a study in China, there are a few points to keep in mind. The sections below describe what needs to be considered. Please do not hesitate to ask if you have any questions.

Where to store the data from clinical trials in China

In China, for some types of trials, the authorities require all data to be collected on servers in China. However, for other types of trials, the authorities allow you to store the data on servers outside of China. The easiest way to handle this is to store all of your data for Chinese studies in China.

Viedoc Technologies has Viedoc servers in China with full backup and geographic redundancy of those servers, also situated in China (in Beijing and Shanghai). Whatever type of study you are running, your data is stored locally and encrypted both at rest and when in transit. You can extract your data for analyses or archiving at any time, in the same way as when using our servers in the US, Europe or Japan.

Using the data centers in China ensures that the response times are as low as possible for the local users. However, for users outside of China, the response time may be slightly higher. That is, a user in Europe may experience slightly higher response time than when working with studies on our European server instance (however, this is a general issue, and not an issue specific to Viedoc).

Data privacy in China

China has a data privacy act called “Personal Information Security Specification” which is very similar to the European GDPR and the Japanese APPI in its protection of personal data. If you are compliant with GDPR and APPI, then you are almost certain to be compliant with the Chinese regulations as well. Viedoc complies with all of the data privacy regulations that affect clinical research, wherever you are in the world.

Human Genetic Resources (HGR)

The Chinese Ministry for Science and Technology is charged with protecting the use of HGR from Chinese subjects. This applies whether the HGR are being used by Chinese companies performing Chinese studies, or by foreign companies performing studies in China. One of their requirements is that all systems that may be used to store HGR data must be registered with the Ministry. Viedoc is registered with the Ministry, and can be used to collect this type of information if you have permission to use it in your study.

Study specific considerations

Compared to the rest of the world, when building and managing Viedoc studies, there is only one aspect to be considered. When studies are run with ViedocMe and reminders are used, we need to inform the sub-processor for sending text messages in China (AliYun), so that these text messages will be allowed and come through to the trial subjects. You will need to work with our IT department to provide us with some details for the study so that we can get approval from AliYun. All system functionality works in the same way and you would not notice the difference of the Chinese instance and the European instance if you are not looking at the URL.

Legal entity and office

Viedoc Technologies has a legal entity in China - Shanghai Weida Information Technology Co., Ltd. Our Chinese clients sign an MSA with our Chinese entity, but it is not needed for any client that already has an MSA with Viedoc Technologies. So you can conduct Viedoc studies in China as long as you have an MSA signed with Viedoc Technologies.

Viedoc Technologies has an office in Shanghai, with a sales team and a team of product specialists. Their job is mainly to support our Chinese customers. There are several CROs familiar with Viedoc in China.

Language

Viedoc Clinic, Viedoc Admin, Viedoc Designer and ViedocMe are available in both English and Chinese as system languages. If the CRFs are set up in Chinese, the entire interface can be in Chinese for the end user. The eLearning for Viedoc Clinic is also available in Chinese.

Sub-processors and system performance overview

We publish the same information for all our instances regarding system performance and sub-processors. System performance can be monitored from here: https://status.viedoc.com/

All our sub-processors used can be found here: https://www.viedoc.com/status-security-privacy/