Conducting clinical audits can present a number of communication challenges. Auditors often travel considerable distances to verify research; the last thing they need is to be unable to speak to clinical staff or verify scientific data. Here are our top tips to ensure successful communications.
1) Start planning early
Having spent years developing pharmaceutical research, an audit shouldn’t fail because people can’t understand each other. Remember no matter how ground breaking your product is or how efficient your work processes are, if your auditors cannot fully understand the data, it will be harder for them to make their assessment.
To ensure the best outcome, you need to employ specialist interpreters. Clinical trials are very specific assignments often including a combination of spoken questions and hours of checking through trial data in an intense atmosphere. You really need to hire an interpreter who knows both your industry and the audit process. It goes without saying, these high calibre interpreters get booked up quickly, so make sure to secure your booking well in advance.
If you location is relatively remote, plan even earlier. While it can be relatively easy to find interpreters in any national capital, there are fewer in smaller towns and cities. Furthermore, if you have a multi-site audit and want the same interpreter with you throughout, they need to be able to book out their schedule well in advance.
2) Set a realistic budget
Make sure you budget for all costs including interpreting, overtime for any work outside normal business hours, travel, accommodation and subsistence. If your auditors are going to split meetings or different sites, you will need a team of interpreters to cover each concurrent project.
A professional interpreter will not be cheap but they will provide value by helping you fulfil your audit process. Optimise your budget by planning early and making savings on travel and accommodation. Early planning also means that you have a better chance of finding a local interpreter rather than having to source from further afield at greater cost.
3) Think about what you need them to do
If you work in partnership with your chosen interpreters, they will be an invaluable part of the team during the audit process – often pre-empting challenges and creating a time efficient process.
Think carefully in advance about where you will need assistance as you will often have multiple demands. For example, Source Data Verification needs to check the data presented in case reports to ensure it is complete, accurate and valid. As well as conveying questions and answers between the auditors and the research teams, you will probably need help with on-site translation of written materials such as test results or patient notes.
4) Think about the practicalities
Briefing the interpreter as much as possible will make sure that everyone gets the best out of the assignment. The highly technical subjects involved have specialist terms and acronyms, so help your interpreter prepare by providing as much background information as possible about the trial. You may also want to consider a short briefing by telephone before the actual start date as well as building in time on the first morning to go over the key points and aims of the visit. Interpreters appreciate the confidential nature of your information and will be happy to sign any NDAs required.
If you have a site where safety equipment is required, check in advance whether the interpreter has safety shoes and clothing or whether you need to make these available.
Interpreting is an incredibly demanding job, so factor in regular breaks throughout the day, a decent place to stay and time on at least some of the evenings to take a break from the project. A well-rested and properly prepared interpreter will offer better quality and more consistent interpreting.
5) Consult an expert
Finding the right interpreter or team of interpreters is critical but also a time consuming process. Delegating to an expert can save time and money and allow you to concentrate on the audit process rather than finding suitable interpreters, verifying their references and work permits and negotiating terms.
At RWS Language Solutions, we work daily with interpreters across Europe, Russia, the US and Asia. We understand the questions to ask and the pitfalls to avoid. In addition, we can provide accurate costings, arrange travel and accommodation, prepare and brief the interpreters in advance of each site visit and review their performance afterwards.
During a recent project, we led a series of source data verification audits across 19 sites in Russia and Eastern Europe delivering the selection, planning and logistics for the whole team of interpreters to time and on budget.
We have spent many years building up our extensive experience and network of resources, so do feel free to contact us, we are happy to share this knowledge.