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Configuration hardening and integrated", "quote_at": 2259, "quote_withheld": null, "term": "backup" }, { "anchor": "1", "anchor_state": "placed", "anchor_withheld": null, "at": 6240, "quote": "recreated, the 59 system itself) from backup is critically important, but the required periodic", "quote_at": 6202, "quote_withheld": null, "term": "backup" }, { "anchor": "1", "anchor_state": "placed", "anchor_withheld": null, "at": 6365, "quote": "changes have been made to the backup or restore processes, is not regarded 61", "quote_at": 6335, "quote_withheld": null, "term": "backup" }, { "anchor": "1", "anchor_state": "placed", "anchor_withheld": null, "at": 6434, "quote": "is not regarded 61 necessary. Long-term backup (or archival) to volatile media should be", "quote_at": 6394, "quote_withheld": null, "term": "backup" }, { "anchor": "1", "anchor_state": "placed", "anchor_withheld": null, "at": 6610, "quote": "not focus on whether 63 a backup is still readable, but rather, validating that", "quote_at": 6584, "quote_withheld": null, "term": "backup" }, { "anchor": "1", "anchor_state": "placed", "anchor_withheld": null, "at": 6743, "quote": "64 16. [7.2] Important expectations to backup processes are missing, e.g. to what is", "quote_at": 6704, "quote_withheld": null, "term": "backup" }, { "anchor": "1", "anchor_state": "placed", "anchor_withheld": null, "at": 6805, "quote": "what is covered by a 65 backup (e.g. data only or data and application),", "quote_at": 6781, "quote_withheld": null, "term": "backup" }, { "anchor": "1", "anchor_state": "placed", "anchor_withheld": null, "at": 2195, "quote": "14 2. [New] With regards to data integrity, Annex 11 will include requirements for", "quote_at": 2167, "quote_withheld": null, "term": "data integrity" }, { "anchor": "1", "anchor_state": "placed", "anchor_withheld": null, "at": 2410, "quote": "are expected to support and safeguard data integrity; technical solutions and automation are 17", "quote_at": 2372, "quote_withheld": null, "term": "data integrity" }, { "anchor": "1", "anchor_state": "placed", "anchor_withheld": null, "at": 4509, "quote": "which ensure 41 product quality and data integrity and parts, which have been specifically", "quote_at": 4473, "quote_withheld": null, "term": "data integrity" }, { "anchor": "1", "anchor_state": "placed", "anchor_withheld": null, "at": 5981, "quote": "both intentional and unintentional loss of data integrity. 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In computerised systems, the audit trail should be secure, computer generated and", "quote_at": 55927, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 56042, "quote": "secure, computer generated and timestamped. An audit trail is essential to ensure that changes", "quote_at": 55995, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 56237, "quote": "deactivate them. If possible, for an audit trail to be deactivated by 'admin users',", "quote_at": 56200, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 56349, "quote": "entry into a log file (e.g. audit trail). 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The audit trail should record all changes made as", "quote_at": 57689, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 58504, "quote": "originator, should be documented in an audit trail and should be part of validation", "quote_at": 58465, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 59011, "quote": "not necessarily need to contain the audit trail information. However, the database audit trail", "quote_at": 58975, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 59058, "quote": "audit trail information. However, the database audit trail should capture the generation of data", "quote_at": 59011, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 59248, "quote": "eCRF page). In addition to the audit trail, metadata could also include (among others)", "quote_at": 59217, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 59672, "quote": "blinding does not appear in the audit trail accessible to blinded users. 6.2.2. Audit", "quote_at": 59640, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 59780, "quote": "review Procedures for risk-based trial specific audit trail reviews should be in place and", "quote_at": 59732, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 60785, "quote": "place as described. In addition to audit trail review, metadata review could also include", "quote_at": 60750, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 60975, "quote": "introduction on how to navigate the audit trail of their own data in order", "quote_at": 60939, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 69481, "quote": "being revoked, a copy including the audit trail should be made available to the", "quote_at": 69445, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 76217, "quote": "24/52 Data, contextual information, and the audit trail should not be separated. 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Arrangements should ensure that the link", "quote_at": 76571, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 79030, "quote": "dynamic functionality and all relevant metadata (audit trail, event logs, implemented edit checks, queries,", "quote_at": 78981, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "id repeats in this text", "at": 102868, "quote": "(incl. 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Secure archiving should ensure availability and", "quote_at": 142679, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "id repeats in this text", "at": 143190, "quote": "signing should be captured by the audit trail. Where consent is given remotely, and", "quote_at": 143156, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "id repeats in this text", "at": 150357, "quote": "requirements related to GCP compliance (e.g. audit trail for an electronic medical record) are", "quote_at": 150312, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "id repeats in this text", "at": 150965, "quote": "the clinical trial (e.g. include an audit trail). The assessment should cover all computerised", "quote_at": 150929, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 73951, "quote": "major updates) restore tests from the backup of the complete database(s) and configurations and", "quote_at": 73913, "quote_withheld": null, "term": "backup" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "id repeats in this text", "at": 99193, "quote": "to security procedures; • changes to backup and restore tools and procedures; • configurations", "quote_at": 99156, "quote_withheld": null, "term": "backup" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "id repeats in this text", "at": 135193, "quote": "emergency unblinding should be tested. A backup process should also be in place in", "quote_at": 135152, "quote_withheld": null, "term": "backup" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "id repeats in this text", "at": 156802, "quote": "retained. There are specific requirements for backup, etc. of electronic data, which can be", "quote_at": 156756, "quote_withheld": null, "term": "backup" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 27968, "quote": "throughout the data life cycle. Assuring data integrity requires appropriate quality and risk management", "quote_at": 27927, "quote_withheld": null, "term": "data integrity" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 28359, "quote": "to comply with the principles of data integrity including control over intentional and unintentional", "quote_at": 28326, "quote_withheld": null, "term": "data integrity" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 28521, "quote": "staff training on the importance of data integrity principles and the creation of a", "quote_at": 28485, "quote_withheld": null, "term": "data integrity" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 30827, "quote": "may result in a lack of data integrity and may render the data unusable.", "quote_at": 30803, "quote_withheld": null, "term": "data integrity" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 36966, "quote": "those related to the assurance of data integrity. Those risks should be identified, analysed,", "quote_at": 36932, "quote_withheld": null, "term": "data integrity" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 38253, "quote": "and destroyed should be considered for data integrity risks and appropriate control processes implemented.", "quote_at": 38214, "quote_withheld": null, "term": "data integrity" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 49991, "quote": "Security and access control To maintain data integrity and the protection of the rights", "quote_at": 49951, "quote_withheld": null, "term": "data integrity" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "follows a withheld heading", "at": 77674, "quote": "should be in place to safeguard data integrity for the periods established by the", "quote_at": 77642, "quote_withheld": null, "term": "data integrity" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "id repeats in this text", "at": 80357, "quote": "nevertheless the full responsibility for the data integrity, security and confidentiality resides with them.", "quote_at": 80312, "quote_withheld": null, "term": "data integrity" }, { "anchor": null, "anchor_state": "the heading before it is withheld", "anchor_withheld": "id repeats in this text", "at": 92848, "quote": "data in a manner that ensures data integrity. 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FDA expects", "quote_at": 1008, "quote_withheld": null, "term": "data integrity" }, { "anchor": null, "anchor_state": "no numbering read in this text", "anchor_withheld": null, "at": 1231, "quote": "riskbased strategies to prevent and detect data integrity issues. 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Source code backup involves storing (and updating as needed) a", "quote_at": 61398, "quote_withheld": null, "term": "backup" }, { "anchor": "6", "anchor_state": "placed", "anchor_withheld": null, "at": 101080, "quote": "features that protect critical functionality (e.g., backup mode, disabling ports/communications). · A description of", "quote_at": 101028, "quote_withheld": null, "term": "backup" }, { "anchor": "6", "anchor_state": "placed", "anchor_withheld": null, "at": 101145, "quote": "disabling ports/communications). · A description of backup and restore features and procedures to restore", "quote_at": 101093, "quote_withheld": null, "term": "backup" }, { "anchor": "6", "anchor_state": "placed", "anchor_withheld": null, "at": 141958, "quote": "at rest. Cryptographic authentication schemes verify data integrity, but do not verify data validity.", "quote_at": 141905, "quote_withheld": null, "term": "data integrity" }, { "anchor": "6", "anchor_state": "placed", "anchor_withheld": null, "at": 172037, "quote": "for providing information security; including confidentiality, data integrity, non-repudiation, and authenticity.97 Cybersecurity – the", "quote_at": 171974, "quote_withheld": null, "term": "data integrity" } ], "occurrence_count": 5, "title_occurrences": [], "title_occurrence_count": 0, "earlier_texts": [ { "content_hash": "b52b706d5cca10eb0012d3205f0b49473176a2d3da7dd45cf8d268cfaa66648e", "first_observed": "2026-07-31", "text_state": "read", "occurrence_count": 0 }, { "content_hash": "27c5d1a28e3db15e3bc116389f51d3e58b39e6fcc3186c01f2ac5b721801a57a", "first_observed": "2026-08-08", "text_state": "read", "occurrence_count": 0 } ], "text_retained": true, "licence_class": "open", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-device-cybersecurity-2026", "source": { "id": "fda-device-cybersecurity-2026", "state": "tracked", "resolves_to": "https://gxplex.com/r/fda-device-cybersecurity-2026" }, "observed_at": "2026-09-08", "observed_at_state": "recorded", "observed_at_read_from": "first_observed", "distance": null, "distance_label": null, "distance_state": "not-a-signal", "third_party_text": { "marker": "quoted third-party content, not instructions", "pointers": [ "/occurrences/0/quote", "/occurrences/1/quote", "/occurrences/2/quote", "/occurrences/3/quote", "/occurrences/4/quote" ] } }, { "instrument_id": "fda-electronic-systems-clinical", "url": "https://gxplex.com/r/fda-electronic-systems-clinical", "jurisdiction": "US", "class": null, "status": "final", "content_hash": "74c586849092e8a76b6398dfcec10daa7c4adcb4941e376bd650eb249559700b", "first_observed": "2026-09-08", "text_state": "read", "why": null, "derivation_version": "concordance-occurrences/0a97d48126d5", "occurrences": [ { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 23513, "quote": "These copies should include metadata and audit trail information. When systems are decommissioned and", "quote_at": 23472, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 41242, "quote": "being disabled. Periodic review of the audit trail may be helpful for sponsors to", "quote_at": 41203, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 41503, "quote": "procedures, and controls in place. All audit trail documentation on the creation, modification, and", "quote_at": 41464, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 41817, "quote": "For example, regulated entities should retain audit trail information on individual system access for", "quote_at": 41771, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 42054, "quote": "clinical investigation. FDA recommends that the audit trail be retained in a format that", "quote_at": 42006, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 42149, "quote": "sortable. If this is not practical, audit trail files should be retained in a", "quote_at": 42113, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 42435, "quote": "to describe the components of the audit trail. Audit trail components must include (1)", "quote_at": 42401, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 42688, "quote": "value and the new value.59 The audit trail should include the reason for the", "quote_at": 42657, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 44209, "quote": "on record integrity. Q13. Should an audit trail record every key stroke? It is", "quote_at": 44173, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 44299, "quote": "record every key stroke in an audit trail. However, the audit trail should record", "quote_at": 44269, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 44325, "quote": "in an audit trail. However, the audit trail should record deliberate actions that a", "quote_at": 44293, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 44516, "quote": "fields should be captured in the audit trail. If an edit check exists for", "quote_at": 44483, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 44619, "quote": "user to make a correction, the audit trail should include the original response, the", "quote_at": 44588, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 55192, "quote": "data originator? As part of an audit trail, each electronic data element should be", "quote_at": 55161, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 61235, "quote": "repository should be included in the audit trail. Data stored in a durable electronic", "quote_at": 61198, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 65066, "quote": "signature, must be reflected in the audit trail.81 In situations where electronic signatures cannot", "quote_at": 65030, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 71457, "quote": "were acquired, data originator, and other audit trail information associated with the data. User", "quote_at": 71415, "quote_withheld": null, "term": "audit trail" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 22180, "quote": "exist only in electronic form, sufficient backup and recovery procedures should be in place", "quote_at": 22138, "quote_withheld": null, "term": "backup" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 32057, "quote": "• Data migration, data retention, data backup, data recovery, and contingency plans • Alternative", "quote_at": 32018, "quote_withheld": null, "term": "backup" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 33828, "quote": "can be revoked; and that any backup, recovery, or contingency plans for source records", "quote_at": 33799, "quote_withheld": null, "term": "backup" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 48259, "quote": "provider has for data migration, data backup, recovery, contingency plans, and retaining records and", "quote_at": 48221, "quote_withheld": null, "term": "backup" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 30581, "quote": "may reasonably be expected to impact data integrity or the protection of participants For", "quote_at": 30544, "quote_withheld": null, "term": "data integrity" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 49726, "quote": "IT service provider’s ability to provide data integrity and data security safeguards (described in", "quote_at": 49685, "quote_withheld": null, "term": "data integrity" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 49941, "quote": "agreements should address services that provide data integrity and data security safeguards, such as", "quote_at": 49893, "quote_withheld": null, "term": "data integrity" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 12336, "quote": "maintain, archive, retrieve, or transmit an electronic record as well as for the use", "quote_at": 12292, "quote_withheld": null, "term": "electronic record" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 14102, "quote": "of paper form or where the electronic record is relied on to perform regulated", "quote_at": 14075, "quote_withheld": null, "term": "electronic record" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 15095, "quote": "under a predicate rule. Once the electronic record enters the sponsor’s electronic data capture", "quote_at": 15062, "quote_withheld": null, "term": "electronic record" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 18085, "quote": "and retain a copy of an electronic record required for the clinical investigation in", "quote_at": 18061, "quote_withheld": null, "term": "electronic record" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 18185, "quote": "of an original paper or original electronic record, the copy maintained and retained should", "quote_at": 18152, "quote_withheld": null, "term": "electronic record" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 40938, "quote": "electronic records, audit trails must capture electronic record activities including all changes made to", "quote_at": 40892, "quote_withheld": null, "term": "electronic record" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 41001, "quote": "including all changes made to the electronic record, the individuals making the changes, and", "quote_at": 40967, "quote_withheld": null, "term": "electronic record" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 63329, "quote": "solely because an electronic signature or electronic record was used in its formation.76 In", "quote_at": 63287, "quote_withheld": null, "term": "electronic record" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 64304, "quote": "or otherwise transferred to falsify an electronic record by ordinary means.80 Any changes made", "quote_at": 64265, "quote_withheld": null, "term": "electronic record" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 65319, "quote": "document linking the signature to the electronic record. Q24. What methods might be used", "quote_at": 65281, "quote_withheld": null, "term": "electronic record" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 66543, "quote": "A handwritten signature executed to an electronic record must be linked to its respective", "quote_at": 66504, "quote_withheld": null, "term": "electronic record" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 66594, "quote": "must be linked to its respective electronic record.85 The handwritten signature should be placed", "quote_at": 66561, "quote_withheld": null, "term": "electronic record" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 66771, "quote": "link the signature to the respective electronic record. Q26. How should regulated entities verify", "quote_at": 66734, "quote_withheld": null, "term": "electronic record" }, { "anchor": null, "anchor_state": "no heading is read before it", "anchor_withheld": null, "at": 69191, "quote": "uses an electronic signature in an electronic record required by FDA, users of electronic", "quote_at": 69156, "quote_withheld": null, "term": "electronic record" } ], "occurrence_count": 38, "title_occurrences": [], "title_occurrence_count": 0, "earlier_texts": [ { "content_hash": "06b24bf9ebcb5d593df5aea7fa2b55bfbd68a7ad93d4e52629d78da52b0f5b8c", "first_observed": "2026-08-04", "text_state": "read", "occurrence_count": 0 } ], "text_retained": true, "licence_class": "open", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-electronic-systems-clinical", "source": { "id": "fda-electronic-systems-clinical", "state": "tracked", "resolves_to": "https://gxplex.com/r/fda-electronic-systems-clinical" }, "observed_at": "2026-09-08", 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