What are the sponsor's considerations when assigning an auditor that is unable to understand the local language of the site?

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What are the sponsor's considerations when assigning an auditor that is unable to understand the local language of the site?

It seems that a local auditor is more familiar with the country's regulations, can communicate effectively with the local study stuff and read the medical records and other source documents without the need of a translator...


Lynda Cedar • If this auditor is able to communicate effectively with the local study staff and read the medical records and other source documents why should s/he need a translator?

If the documents are well developed, completed as they should be, following the study protocol, the SOPs, the regulations and other requirements (local), if the auditor is qualified and knows where to look, s/he may not need a translator mainly when s/he is able to communicate effectively with the study staff.

Yulie Feldman-Idov • I meant in case of a foreign auditor that does not understand the local language, can not read the source documents without translation and sometimes can not communicate effectively with the study stuff due to language barriers

Dominique Chesnais • The role of an auditor is to ensure compliance to the requirements of the protocol and annexes, international and local regulations, and sponsor's SOPs. His/her role is not to monitor a clinical trial, as does a local CRA, but to audit a clinical site within a clinical trial or project. Furthermore, clinical R&D is done in English language and, at least, a site member (PI, Sub Inv, Coordinator) and the CRA should be fluent in English.

An international auditor has better knowledge and experience of the global running of a project than a local auditor would have. A local auditor will be well aware of all local requirements and events in his/her country, but not beyond.

I agree that international auditors lack of regulatory knowledge of many countries where they audit. Local regulations are mainly written in the local language and never well translated in English or not at all. Few companies have built a database of local regulatory specificities.

International auditors assess a site and its trial with the international, FDA, EMA, English-written regulations, where the “most fear” inspectors are based. Also, local regulations are based on international requirements with few local conditions, which should have been taken into account during the clinical trial submission process. However, the sponsor is always responsible for the failure of third-parties.

About auditing medical records in a language that an auditor/inspector cannot read, they use some specific techniques to check CRF vs. patient’s source documents. It just takes longer to perform, it requires the help of a local person (CRA, site personnel) for the translation, but it is not as efficient as an audit performed in a language read by the auditor.

It is not feasible for most pharmaceutical companies to have a local auditor in each country where they perform clinical trials. It would be too expensive for companies and not enough challenging for local auditors, limited sometimes to few local studies, even none. On the other hand, it would be good for companies to contract the services of an independent, freelance, local auditor, working in pair with a sponsor international auditor.

Jim Sheets • I schedule my audits to coincide with a scheduled monitoring visit; this way I can utilize the local CRA's language to enhance communication with site personnel. "Across-the-table" auditing is sometimes used - the auditor has the CRFs and asks the coordinator to supply a value from the source. It's slow. Then, I might have the CRA or coordinator read sections of the medical chart.

If we use a large CRO (e.g., Kendle, Quintiles) that has a large, multinational team of GCP auditors, I may ask them to serve as part of the audit team. In any case, the lead auditor must research local GCP laws a priori; getting those regulations in English can sometimes be challenging - you may have to pay for translation.

Lynda Cedar • Thank you Yulie for the clarification. Now, Dominique and Jim answered your question.

The way explained by Jim how do pharmaceuticals proceed for auding and inspecting when they conduct clinical studies in countries where the English is not the language of work (typically emergent countries) is the most used one. However, efficient translator must be familiar with the terminology of clinical research and regulations. In such case, the local certified translator who was used to translate and certify the ICF might be used again. S/he knows about the study as he had the protocol and the ICF at the time he translated the ICF.

I agree with Dominique that foreign pharmaceuticals (US, Canada, Europe, etc.,) develop the study documents including the CTRA in English. The parties (pharma and sites) face this kind of questions at the end of study or other issues during the study, when either they are junior (not enough back experience) or do not use the CTRA that describes every thing about the study and how it will be handled at the different steps: pre-study, on-study, close-out and even post-study if required. The way how they perform the auditing and monitoring is included in the CTRA.

Yulie Feldman-Idov • Thank you all for the detailed explanations!