At last, some interesting changes in the Data and Records section!  Maybe now we can talk about something besides grammar and punctuation. 

In section 3.16.1, Data Handling, the following changes were made:

• Step 3.16.1 (b) regarding data review, which previously stated, ""The sponsor should focus their quality assurance and quality control activities and data review on critical data" now states "The sponsor should focus their quality assurance and quality control activities, including data review, on data of higher criticality and relevant metadata."  The revision eliminates the awkward chain of "ands" and also emphasizes that metadata should be reviewed along with data - an important point that we'll address in a later blog post.
• A new step (g) was added to this section:  "The sponsor should put procedures in place to describe unblinding, where applicable; these descriptions should include: (i) Who were unblinded, at what timepoint and for what purpose they were unblinded; (ii) Who should remain blinded; (iii) The safeguards in place to preserve the blinding." While this is exciting (new content!), it is also not clear. The first sentence states that unblinding "procedures" should be put in place, but how could a procedure include "who were unblinded, at what timepoint and for what purpose"? Perhaps the framers intended "who were" to be conditional (i.e., the roles intended to be unblinded, at what timepoint, and for what purpose - see how the Oxford comma makes that flow so much better?  Don't even get me started on the use of the colon after the dependent clause.)
• Step (i) in this section regarding data changes has been amended from "The sponsor should not make changes to data entered by the investigator or trial participants unless justified and documented by the sponsor and agreed upon by the investigator" to  "The sponsor should not make changes to data entered by the investigator or trial participants unless justified, agreed upon in advance by the investigator and documented."  "In advance" adds a significant new requirement to this process.
• The text in bold has been added to Step (l):  "The sponsor should not have exclusive control of data captured in data acquisition tools in order to prevent undetectable changes."  The added text helps clarify the rationale for this step.  This addition goes hand-in-hand with the changes in step (k), where the bolded text has been added: "The sponsor should ensure that the investigator has timely access to the required data for retention purposes." If sites are not given timely access to their own data - for example, if the sponsor waits six months after database lock to send out eCRF representations from the EDC system to the site - then, technically, the sponsor has "exclusive" control over the data for those six months and could change data, changes that would go undetected because the sites would not have their own copies of the data. Note that E6 does not confine these requirements to EDC data - investigators should be given timely access to ALL sources of data, including central laboratory data and ePRO data.  The final version of step (k), however, changes the statement "The sponsor should pay special attention to data that may unblind the investigator" to "The sponsor should not share data that may unblind the investigator."
• Step (p) in this section regarding data cleaning plans for various deliverable types adds a new sentence, "Completion of these steps should be documented."
• A new step (q) has been added to this section:  "For planned interim analysis, the ability to access and change data should be managed depending on the steps to achieve data of sufficient quality for analysis." As with the new step (g) above, this is a bit awkwardly worded, but the point about managing access to data is clear.
• Step (r) regarding whether or not you should continue to capture data during interim analysis activities has been changed.  Previously, it said, "Prior to provision of the data for analysis, edit access to the data acquisition tools should be restricted as appropriate to the purpose of the analysis; for example, for interim analysis, the restriction may only be temporary or managed differently compared to the final analysis." Now, the italicized text has been deleted. The prior wording appears more in line with how most companies handle this process. 
• A step in this section regarding deviations from planned statistical analyses has been moved to section 3.16.2.
• Step (w) in this section now differentiates between steps the sponsor should take with regard to computerized systems deployed by the sponsor, those deployed by the investigator/institution, and all systems.  For sponsor-deployed systems, sponsors should maintain an inventory; have lifecycle procedures in place; maintain records of authorized users; ensure site staff are granted appropriate permissions; and ensure that vendors and sites have a mechanism to inform the sponsor of defects.  For investigator/institution systems, the sponsor should assess whether systems are fit for purpose before the start of the trial.  For all systems, sponsors should ensure that vendors and sites have a mechanism to inform the sponsor of non-compliance related to the system.

In Section 3.16.2, Statistical Programming and Analysis, the following additional changes were made:

• Step (a) has been added to address a fairly large gap:  "The sponsor should develop a statistical analysis plan that is consistent with the trial protocol and that details the approach to data analysis, unless the approach to data analysis is sufficiently described in the protocol."
• Step (d) regarding the per-protocol analysis was changed with the addition of the bolded text "The sponsor should ensure that the criteria for inclusion or exclusion of trial participants from any analysis set is pre-defined (e.g., in the protocol or the statistical analysis plan)."  
• Step (f) regarding statistical outputs adds the following bolded text:  "Outputs should be traceable to the statistical software programs, dated and time stamped, protected against any changes, and have access controls implemented to avoid inappropriate
  viewing of information that may introduce bias."

Section 3.16.3, Record Keeping and Retention, has changed as follows:

• Step (c) regarding the sponsor's responsibility to report transfer of ownership of essential records to regulatory authorities now includes this addition:  "The sponsor should also inform the investigator if sponsorship of the trial changes."

Section 3.16.4, Record Access, has changed as follows:

• Step (b) regarding the requirement for trial participants to consent to direct access to their records now uses the term "source records" instead of "original medical records and other participant-related trial documents."