People outside the Clinical Outcome Assessment (COA) translation space often (wrongly) assume that once a questionnaire has been selected, the next step is simply to translate it into the required languages. However, translation is only one piece of a much more complex process. Every translated questionnaire represents years of research, linguistic validation, licensing considerations, regulatory compliance expectations, and collaboration across multiple specialist disciplines. Treating COA translation as "just translation" can introduce unnecessary delays, quality risks, and additional costs later in a study. Read our blog to learn the four issues that skipping specialized COA translation services will create.

#1 Licensing Gets Overlooked

Successful COA translation begins long before the first word is translated. This involves a lot more than just permissions. Ensuring the appropriate COA licensing is in place is a critical first step, requiring careful consideration of:

• Copyright ownership
• Commercial licensing
• Authorized versions
• Version Control

Working with clinical trial translation services providers who have a deep understanding of these areas is vital. Without it, your provider may use the wrong version of your COA, invalidating months of downstream work. Experienced life sciences translation providers, such as Lionbridge, have decades of expertise in handling COA licensing. We can ensure your COA translation projects are handled on time, smoothly, and fully in compliance. It saves significant costs down the road when everything is done correctly and compliantly the first time.

#2 Skipping COA Translation Services Means Your Clinical Data Is Put at Risk

Linguistic validation helps to preserve the meaning of the COA’s questions for patients, regardless of culture or language. While typical translation approaches may translate COAs word-for-word, they don’t include a linguistic validation process. This process involves several complex steps that require deep experience and familiarity with regulatory compliance. They are:

• Conceptual equivalence
• Linguistic validity
• Cultural adaptation
• Cognitive debriefing and/or clinician review
• Instrument developer review and approval (where applicable)
• Global harmonization

Without the appropriate training, education, and certifications, translation providers cannot cover these steps. COAs may become ineffective and non-compliant, yielding poor clinical trial results and research, worsening patient outcomes, leading to potential noncompliance fees or regulatory actions, and ultimately posing risks to patients. Choosing clinical trial translation services that specialize in COAs is the only way to avoid these serious consequences.

#3 Rejecting COA Translation Means Being Unprepared for eCOA Complexities

Clinical Trials are becoming more digitized, using electronic clinical outcome assessments (eCOAs) to improve data accuracy, patient engagement and compliance, cost efficiency, data security, and streamline workflows. While eCOAs have many benefits, they also introduce new complexities that an eCOA translation provider must be prepared for. These may include:

• Software implementation
• Screen limitations
• Migration requirements
• Usability testing
• Screenshot review
• User Acceptance testing (UAT)

Teams with eCOA experience know that a validated paper instrument doesn’t automatically become a validated electronic one. Skipping professional COA translation services means skipping out on the expertise necessary for successful eCOA migrations and translations.