Indonesian Linguistic Validation Definition
The terms of research might be confusing and intimidating. Linguistic validation is one of the terms.
For those who do not really know the meaning, linguistic validation will sound complicated.
The term is related to a clinical research.
Linguistic validation is a necessary step for giving qualification for a multinational trial.
The step is for providing protection in the data pools.
Therefore, to use Indonesian linguistic validation service is an essential step in the complex procedure of the research in medical area.
The linguistic validation is necessary for avoiding rejection.
In most cases, the clinical research trials are at risk of being rejected because of the poor Indonesian translation.
When the patients cannot clearly understand the data, they might give the improper response to the data. Besides, the poorly translated clinical documents or instruments will not give a strong evidence to support the trials.
In the USA, Food and Drug Administration even requires people to use two types of procedures before submitting the documents. The first is the linguistic validation. Besides, the text also needs to be improved with the cognitive debriefing. The submitted translation and the overall content will be acceptable with both features.
Process of Indonesian Linguistic Validation
Indonesian linguistic validation is not a simple translation process.
It requires multiple translations done by several native skilled translators.
First of all, the translator will translate from English to Indonesian language all the patient questionnaire. The material can be some other types of instrument. Different translators will do the jobs. After that, the translators will recheck the different version of translation products.
Next, the linguists and the translators will work to back-translate the documents together to see whether the results are still the same compared to the source text or data. This is due to evaluate the possible difference between the products and the source language.
The quality of the reconciled translation will determine the final grade of the linguistic validation process.
Here is the summary of the process Indonesian linguistic validation:
- Preparation that includes the text research. Two independent translators will render the source instrument before starting the translation. Only native language experts can do the forward translation since they will be able to find the best language equivalence to match the source text.
- Translation procedures with keen accuracy
- Reconciliation: the steps that include the procedure of comparing the forward translation and do the back-translation. The back-translation has to be performed by other two different translations. They should be the translators who have not seen the documents before.
- Harmonization which means finding the right terms to get the most accurate results.
- Cognitive debriefing
- Finalization by a project manager. The final review will take some times. The expert and experienced project manager will be able to make a decision whether the linguistic validation has reached a final result.
What documents will need a linguistic validation?
Not only a clinical research needs a linguistic validation.
Any documents related to medical statements for some purposes will need to pass the procedure.
The examples are:
- Patient Reported Outcomes (PROs)
- Clinician Reported Outcomes (ClinROs)
- Observer Reported Outcomes (ObsROs)
- Quality of Life (QOL) questionnaires
All of the documents are called instrument in the entire process of linguistic validation.
The procedure is essential because medical statement should be extremely accurate.
One small error in the translation will create a totally different outcome. Besides, a single mistake might lead to a different conclusion on the instrument.
Additionally, medical statements are related to the patients bodies, health, and physical conditions.
Therefore, the statements should be all correct and flawless.
In conclusion, there are several purposes of linguistic validation. Here are some of the purposes:
- The linguistic validation is used for ensuring the quality of the target language produced by the translation.
- Target language should not only be equal in terms of meaning but also precise compared to the original instrument. In addition, the procedure will ensure if the product will deliver equivalence of construct value. Each culture on the instrument should remain similar to the original text.
- The statistical elements inside an instrument should be similar in all languages to which the documents are translated.
- The linguistic validation should construct a document with similar value and concept. Even if the locales are way different, the translation result should maintain the originality contained on the source instrument.
Only the best and experienced translation agency can provide the service for Indonesian linguistic validation.
Therefore, it will be important to search the best service for the inquiry.