As I start to write this blog I have to admit this is not a topic in which I consider myself an expert. I think more of as a pessimist actually. I have never had a negative experience with a Monitor as a translator during an audit BUT nevertheless, I take a few risk-mitigation precautions. As auditors we are independent from those conducting and paying for the research. This is the only way unbiased information is collected and reported.
So when we visit locations where we are not native/fluent/proficient speakers/readers of the language used to record/discuss the research we find ourselves unable to do our jobs; enter the translator. This seems obvious enough. A translator provides oral and written information to the auditor so the auditor can assess, ensure, review, etc…all those verbs. But how does the auditor know that the translation is accurate? That all the information is present? In my experience, the translator hasn’t read every word or every progress note to me. I simply rely on a summary after asking targeted questions. There is no reason to think that the translator would leave something out; right? Well actually, when the translator is employed by the person who oversees or pays for the research they are not independent. In fact, auditing at say clinical trial sites involves a fair amount of assessment of the Monitor’s performance, so the independence is further compromised if the translating Monitor is the site’s assigned Monitor. Yikes, what do we know about this Monitor actually. Are they native/fluent/proficient in the auditor’s native language? If the answer is no, details may be lost in translation without malice.
So what’s a thoughtful auditor to do? I translate some key words, say those in the protocol and some of my favorites like “death”, “illness”, “medication” and have it handy to spot check before handing a document to the Monitor for translation. Oh, and I’ve asked for a Monitor not working at this site, on this study or even for the Sponsor.
Back to reality, I am likely to encounter that there are not that many resources available to assist me. Perhaps even the site personnel are not comfortable having a foreigner in the office so they specifically request their site Monitor with whom they have an established relationship. So what’s the next best thing? Smile, talk to the Monitor before going on site, explain your role as the independent auditor, try and establish a positive working rapport and get the work done. We are all on the same team after all.

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

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ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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ICH (E6) R2 Addendum - Step 4

 

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