Clinical trials operate within a highly regulated environment where precision and compliance are essential. Understanding their specialized terminology is essential for risk mitigation and achieving legally defensible outcomes.
As a resource, we’ve compiled a glossary of frequently used terms related to clinical trials and medical documentation (listed in alphabetical order).
Adverse Event (AE) – Any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the treatment.
Clinical Protocol – A document that describes the trial’s objectives, design, methodology, statistical considerations and organization. It must ensure the safety of the trial subjects and integrity of the data.
Clinical Trial – A research study performed in human volunteers to determine if a new medical approach, treatment or device is safe and effective.
Confidentiality – The principle that information shared by a patient or research subject with a medical professional or researcher will not be disclosed to others without explicit permission, vital in clinical research to protect participants.
Contract Research Organization (CRO) – An organization that contracts with pharmaceutical, biotechnology and medical device companies to manage clinical trials and research functions.
Electronic Health Record (EHR) – A digital version of a patient’s paper chart. EHRs are real-time, patient-centered records that make information available instantly and securely to authorized users. Accurate translation is required for international use.
Good Clinical Practice (GCP) – An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance is key to trial integrity.
Health Insurance Portability and Accountability Act (HIPAA) – A federal law that protects sensitive patient health information from being disclosed without the patient’s consent or knowledge. All translations of medical documentation in the US must be HIPAA compliant.
Informed Consent – The process by which a patient or trial subject voluntarily confirms their willingness to participate in a particular trial after having been informed of all aspects of the study, including its purpose, procedures, risks and benefits. Translations of consent forms are considered vital documents for regulatory compliance.
Institutional Review Board (IRB) – An independent ethics committee responsible for reviewing and approving clinical trial protocols and informed consent forms to ensure the protection of the rights, safety and well-being of human subjects.
Validation / Linguistic Validation – The process of testing a translated or culturally adapted document, such as a patient-reported outcome (PRO) measure, to confirm that it retains linguistic and cultural equivalence and measures the same concept in the target language as the original.
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