Traceability of documents and data. All documents and data shall be produced and maintained in a way that assures control and traceability. Where relevant, the accuracy of translations shall be guaranteed and documented. All documents, and subsequent versions, related to a clinical investigation shall be identifiable, traceable and appropriately stored to provide a complete history of the clinical investigation. The investigator shall assure the accuracy, completeness, legibility and timeliness of the data reported to the sponsor on the CRFs and in all required reports. Where copies of the original source document as well as printouts of original electronic source documents are retained, these shall be signed and dated by a member of the investigation site team with a statement that it is a true reproduction of the original source document.
Traceability of documents and data. All documents and data shall be produced and maintained in a way that ensures reliability, integrity, control, and traceability. All documents, and subsequent versions, related to a clinical investigation shall be identifiable, traceable, and appropriately stored to provide a complete history of the clinical investigation. Where relevant, the accuracy of translations shall be guaranteed and documented. The investigator shall ensure the accuracy, attribution, completeness, legibility, and timeliness of the data reported to the sponsor on the CRFs and in all required reports. All copies of the retained original source documents shall be certified, as indicated by a dated signature by a member of the investigation site team unless generated through a validated process. Special requirements should be applied to the capture, review, and retention of electronic source data, to ensure reliability, quality, integrity, and traceability.
