WHO clinical registry standards

Interventions from clinical trials are a crucial component of healthcare. “Every clinical study must be recorded in a publicly accessible database before recruitment of the first subject,” the Declaration of Helsinki mandates. Establish a clinical registry to create a baseline data quality level, validate data, and improve universal access and Validity of research data. A clinical trial register is an official record of the clinical research’s minimal, globally agreed-upon quantity of data that is kept and maintained in a database.

Participating primary and partner registries must adhere to predetermined requirements to maintain data uniformity. These six essential standards are:

• Content – The trial registration data set has 24 points that must be followed.
• Quality and Validity – verifies the accuracy of the information registered and adherence to best practice guidelines.
• Accessibility guarantees that database entries and information are available around the clock in both English and local languages.
• Unambiguous Identification – assures trial registration only needs to be done once and offers an impressive trial identification number.
• Technical Capacity – safeguards against corruption and data loss
• Administration and Governance – Information on ownership and governance is available to the public. It also establishes a data transfer method in the event the registry cannot continue operating.

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