{"id":6740,"date":"2025-09-07T23:50:43","date_gmt":"2025-09-07T21:50:43","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=knowledge-hub-mag&p=6740"},"modified":"2025-11-20T10:37:29","modified_gmt":"2025-11-20T09:37:29","slug":"gcp-snippets-a-treatise-of-essentiality-in-two-lists","status":"publish","type":"knowledge-hub-mag","link":"https:\/\/fgk-group.com\/de\/knowledge-hub\/magazin\/gcp-snippets-a-treatise-of-essentiality-in-two-lists\/","title":{"rendered":"GCP Snippets: A Treatise of Essentiality in Two Lists"},"content":{"rendered":"\t\t
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Find a safe way across \u201cEssential Documents\u201d – Picture by FGK generated with AI<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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\"The essential records permit and contribute to the evaluation of the conduct of a trial [\u2026]\"<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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If you have worked with ICH E6 before, be aware that in ICH E6 (R3) the following definition is gone:<\/p>

\u201cEssential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.\u201d<\/em>
Also vanished is a harmless announcement that had slowly transformed into a curse:\u00a0\u201cThe minimum list of essential documents which has been developed follows.\u201d<\/em><\/p>

ICH E6 (R3) features the definition in a modified way, now as a claim:\u00a0\u201cThe essential records permit and contribute to the evaluation of the conduct of a trial [\u2026].\u201d<\/em><\/p>

By being so broad,\u00a0the former definition<\/em>\u00a0allowed anyone who makes a living from files to increase the amount and type of required documents deliberately by arguing that the previous versions of ICH E6 explicitly stated that section 8 contained just a \u201cminimum list of essential documents\u201d.<\/p>

Therefore, the argument continued, ICH E6 invites every person of good will to increase the number of the documents to also increase the benefit of the collection of essential document. The GCP Inspectors Working Group of the EU followed this imagined invitation happily in their \u201cGuideline on the content, management and archiving of the clinical trial master file\u201d, which praises the affluence of files: the ICH E6 list of essential documents\u00a0\u201cshould not be used as a definitive checklist for TMF [trial master file] content. It is not an exhaustive list. Depending on the activities being carried out, many trials require additional documents not specifically mentioned\u201d.<\/em><\/p>

The problem with such an approach (as well as with the original wording of ICH E6) is that you do not know where to stop expanding the list of required essential documents: You could add data of the investigator\u2019s sleep tracker: If the previous night lacked REM sleep, he should not make intricate assessments. Add the printout of the participant\u2019s bank account: If his salary is too low, the reimbursement is too high to assume that \u201cproblems of coercion or undue influence\u201d for consent are absent. While this might look too bizarre, it is hard to argue that they would \u201cpermit evaluation of the conduct of a trial and the quality of the data produced\u201d to a lesser degree than, let us say, a signed checklist.<\/p>

The new ICH E6 (R3) Annex 1, Appendix C tries to limit arbitrary expansion of essential records by three measures: First, instead of a broad definition it provides a list of 28 mostly specific
criteria, like\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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