For clinics, hospitals, and medical centers, making sure their clinical trials are accurate and understandable is essential.
If you’re looking for an experienced translator to help with the Spanish version of your clinical research study materials, I’m your go-to person. I translate:
- Informed consent forms
- Patient and family documentation
- Patient recruitment and retention materials
- Patient instructions
- Patient informed consent forms
- Patient questionnaires and surveys
- Interactive media
- Package labeling
- Research documentation
- Reports
And more!
Literal translation (swapping one word for another) isn’t enough for healthcare content in general: It’s crucial to hire skilled professionals with expertise in maintaining cultural and linguistic accuracy across languages to handle your translations. This ensures that the content is as clear and accurate as possible for native speakers and readers.
And clinical research translation into Spanish, in particular, requires an in-depth understanding of the medical field, the variety of Spanish at hand (e.g., US Spanish), and, of course, the ability to communicate with clarity and accuracy. I have all the skills and experience necessary to make sure your clinical trial materials are translated properly.
Linguistic validation of patient-reported outcomes (PROs)
In addition to clinical trial translation services, I also offer linguistic validation of patient-reported outcomes (PROs) in Spanish. In 2009, the FDA began to require evidence from clinical trial sponsors that the content of the PROs used in their studies was valid and consistent.
PROs are a specific type of clinical outcome assessment (COA), in the form of questionnaires, surveys and interviews, that measure the health status or quality of life of a patient as directly reported by patients or study subjects. In other words, it’s not a clinician, caregiver, or observer who makes the assessment, but the patient themselves.
PRO data is valuable for a myriad of use cases:
- Drug development
- Medical device development
- Regulatory approval
- Reimbursement decisions
- Product marketing
- Evaluation of disease progression
- Treatment efficacy assessment
Poorly translated documents and materials for any COA, but for PROs in particular, may result in inaccurate, inconsistent, or inconclusive data pools, and even invalidated trials as a result of data corruption.
The whole patient journey may be hindered, and in some cases even halted. Through linguistic validation, researchers can deploy instruments with confidence, knowing that there’s no room for misinterpretation or confusion.
Materials I validate and how I do it
The first thing I look for during my PRO validation process is that the translator has achieved an appropriate reading level and conceptual equivalence in the target language. This means that the same meaning and accessibility of the original version should be present in the translated version.
Next, I check for accuracy, grammar, spelling, and punctuation. I also ensure that I abide by the recommended methodologies of the FDA and ISPOR, meet the relevant regulatory requirements, and adhere to the current best practices of clinical research.
Some of the PRO materials I validate include:
- Manuals
- Protocols
- Informed consent forms
- Case report forms
- Interview scripts
- Questionnaires
- Data collection forms
- Other patient-facing materials as needed
I understand the importance of accuracy and precision when working with critical research materials, and thus, I strive to deliver the best results possible. If you need help translating or validating PRO content, don’t hesitate to reach out!