Background

Conducting world-wide clinical research requires CRFs to be available in the participating clinic’s native language. This makes data entry post-data collection a complex process. Currently the majority of studies have two main options for this: collect data on paper-based forms or use an electronic format to collect the data. Paper-based Multilanguage data collection usually requires a local data entry person to enter the data into a useable electronic format. Then the multiple language electronic databases or spreadsheets have to be merged together which is a complex process for the data manager. Alternately, the electronic database can be used but is limited to displaying the information in one language, mainly in English.

When multiple databases are merged, there is potential for errors. For example, if the fields are translated in addition to their text labels or the value options are in multiple languages, complex matching dictionaries are needed in order to normalize the data into one language.  Not to mention if there is data entry that occurs from paper source documents, the possibility that there will be compromised data is much larger.

Challenge

The challenge is to provide an interface in multiple languages that can be used with or as a part of an EDC so that the data can be captured in real-time making the electronic version the original source document and allowing all the data, not matter what language it was entered in, to seamlessly be collected into one database. In order to ensure the highest quality of data was captured, the system would contain edit checks and messages ensuring all key and complementary data are captured. When data should fall within a given range, alerts should flag outlying values so they can be checked in real-time and measured again if necessary to confirm validity.

Since some of data being captured will be in free text form, the proposed solution would need to have a way for the translations into the final language to be captured directly into the EDC.

Proposal

Prelude Dynamics’ electronic data capture system, VISION™, already allowed researchers to capture information in real-time, provided standardized scales in a just-in-time manner, and adapted well to the natural work flow of complex study processes. It was proposed that Prelude add multi-language capability and a solution to capture translations directly into the database.

Solution

Prelude added a multi-language function to VISION. Basically, the user is now able to select between multiple languages as required by the study. Currently, the languages that are available are Chinese, Dutch, English, French, German, Hungarian, and Spanish. Additional languages will be added as studies require them. Once the end user selects a language, the text on the CRFs are automatically presented in the chosen language. The language settings are saved for future login and can be changed at any time without compromising data collection. All field names remained in English.

To facilitate translation of text entry fields, additional fields were included that were only visible to the roles involved in translating. The translator could then enter the translation into the available field. The translations were available in the CRF in which the data was collected. Upon export, both the translation and the original text would be exported.

Results & Benefits

Data is being collected internationally in the country’s native language. This facilitated the training of participating sites, increased their confidence in collecting data, and ultimately improved data collection and protocol compliance.

As real-time data is entered into VISION™, edit checks and warnings provide feedback in the appropriate language reminding researchers to collect missed data, check data that is outside of a normal range, and helping clean the data as it is collected. Monitors who are located remotely can log into the system on a daily basis and quickly identify any possible action items and tend to them quickly. Translators can log into the system on a regular basis, quickly identify items to be translated and enter the translations right next to the field they are translating.

Data managers no longer have to figure out how to combine multiple databases and no longer have the need to create complex matching dictionaries. They report the data is cleaner and easier to analyze. The time they spend on cleaning the data and normalizing it has practically been eliminated. The time to locking and archiving the database post-data collection has also been reduced from 9 or more months down to a couple of months.

VISION’s multi-language capability met and exceeded the expectations of the sponsor. They report they have greater confidence in the global data they collect and their study has run more effectively and efficiently.