Top Tips on How to Manage Clinical Label Translation and Regulatory Requirements
7월 27, 2020 By Kevin Shea (2 minute read)
Wouldn’t it be nice to find a way to stay on top of label translation and regulatory requirements for every country included in your clinical trial? Nothing is more frustrating than trying to track down regulatory requirements and develop compliant text, while trying to juggle all the other day-to-day activities related to your clinical trial planning. Sometimes a little planning upfront can yield huge results further down the road. Here are a few top tips on how you can invest your time and efforts so as to accelerate clinical trial readiness, particularly for global trials:
- Create or get access to a central repository to store country-specific requirements. A database would be ideal, but even a SharePoint site would be a positive step in the right direction, where everyone can enter translation and regulatory information related to your trials. It is a good idea to gather knowledge on country-specific requirements and to store them so that you can reference and use them for future use.
- Schedule quarterly reviews to make updates to the content for each country. Once you have established your standard regulatory requirements for each country, schedule a review period on a quarterly basis. This can be done with your internal regulatory team or using a partner with expertise in clinical label requirements to ensure your information is up to date. It helps to speed up the final label review. Instead of having to have a detailed check of the text every time, the final review becomes a quick check for content and formatting.
- Use previously approved text for new labels. Develop a database of previously approved text either in-house, or in partnership with a specialist label provider. That way you will be able to easily access text that has already been preapproved, whether for this trial or for another one you are working on. Implementing an approved phrase library has been shown to shorten label cycle times by more than 50%, improving clarity and consistency and reducing the workloads of clinical teams and affiliate staff. Using preapproved text for new labels will also shorten regulatory review timelines.
- Use a system to automate the export of the label text. Manual processes can take time and are prone to error. A better approach is to develop or source a system that can automatically pull the information it needs for the label. Develop a process that is completely paperless; affiliates can translate, review and approve label content electronically. That way, you can rest assured that all requirements are met, removing the potential for error and accelerating clinical trial readiness, particularly for global trials.
To learn more, we invite you to download our Reasons for Building an Approved Phrase Library eBook.
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