Today marks our penultimate post on this topic, in which we ponder the essentiality of records. 

• Section C.1.1, part of the introduction, now describes the desired approach to documentation as "risk proportionate" rather than "proportionate."
• Section C.1.3 i the introduction has been rewritten . The statement "The essential records are used as part of the sponsor oversight or investigator supervision of the trial" now reads,  "The essential records are used as part of the investigator oversight and sponsor oversight (including monitoring) of the trial." The reference to records that are "generated...after the trial" has been changed; the section now clarifies that investigators retain records after the trial is over. 
• Section C.2.1, regarding management of essential records, now refers to "physical" records instead of wet ink. 
• Section C.2.3 rewords the descriptions of the Trial Master File and Investigator Site File so that it is now clear that the sponsor and investigator files, collectively, are known as the Trial Master File; the investigator files may also be known as the Investigator Site File. 
• Section C.2.6, regarding access to files, has added the bolded text:  "The sponsor and investigator/institution should retain the essential records in a way that ensures that they remain complete, readable and readily available and are directly accessible upon request by regulatory authorities, monitors, and auditors."
• Two points have been added to Section C.2. on Management of Essential Records: C.2.10 notes that some records are retained by the sponsor, some by the site, and some by both parties.  C.2.11 notes that blinding and privacy concerns may prevent sharing. 
• Section C.2.12, regarding essential records that are not study-specific, now cites the Investigator's Brochure as an example.
• Section C.3.1, regarding the "essentiality" of records (love that term!), now reassures us that an assessment of which records are essential, "whilst important, is not required to be documented."  Bonus points for use of "whilst," which we Americans don't hear every day. 
• In the list of criteria for essentiality in C.3.1, "trial-specific activities" has been rewritten as "significant trial-related activities."
• In the list of criteria for essentiality in C.3.1, the criterion "contains the data as well as relevant metadata that would be needed to be able to reconstruct the trial" has been changed to  "contains the data as well as relevant metadata that would be needed to allow the appropriate evaluation of the conduct of the trial," which is probably more precise, but eliminates a useful metaphor that helps people understand why records are critical.
• The equivocal statement in the draft C.3.2, "The trial records for every trial that are considered essential, except in justifiable and documented exceptional circumstances, are set out in Table 1," has been revised to "Applying the criteria in section C.3.1, the trial records that are considered essential are listed in the Essential Records Table." Instead of two tables in the draft, one with essential records for all trials and a second with potential essential records, the final version now lists one table, and it is up to the sponsor and site to determine what should be filed per the essentiality criteria.