Updated Form FDA 1571
Aug07

Updated Form FDA 1571

FDA has updated Form FDA 1571 again and posted a new version to the FDA Forms web page, replacing the previous version, released in April 2018.

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Updates to Common FDA Forms
May10

Updates to Common FDA Forms

We recently posted about the August 2017 updates to common FDA forms included in eCTD submissions. Well, they’ve been updated yet again. Several FDA forms are now showing a revision date of April 2018, including: Form FDA 356h Form FDA 1571 Form FDA 3674 The easiest way to ensure that you’re using the current version of these forms is to download new copies directly from the FDA Forms page on FDA’s website. If you already have...

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Trial Summary Dataset: An Overview
May01

Trial Summary Dataset: An Overview

The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) Trial Summary dataset has become increasingly useful to reviewers.  The Trial Summary (TS) dataset allows the sponsor to submit a high-level overview of the trial in a structured format. Each record in the Trial Summary dataset contains the value of a parameter, a characteristic of the trial. For example, a Trial Summary dataset is used to record basic information about the study such as trial phase, protocol title, and trial objectives. The Trial Summary dataset contains information about the planned and actual trial characteristics.

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Transparency Vital to Regulatory Publishing Projects
Nov19

Transparency Vital to Regulatory Publishing Projects

Agile relies on transparency. Decisions to optimize value and control risk are made based on the perceived state of the artifacts. To the extent that transparency is complete, these decisions have a sound basis. To the extent that the artifacts are incompletely transparent, these decisions can be flawed, value may diminish and risk may increase.

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Managing Regulatory Publishing Projects Using Agile
Oct22

Managing Regulatory Publishing Projects Using Agile

When following the Agile Methodology for Regulatory Submissions, events are used to create regularity and to minimize the need for meetings outside of the methodology. All events are time-boxed, meaning every event has a maximum duration. Once a Sprint begins, its duration is fixed and cannot be shortened or lengthened. The remaining events, such as Daily Stand Up Meetings, may end early if they have achieved their purpose, but cannot run over the allotted time. Such an approach ensures that an appropriate time is spent without introducing wasted effort into the process.

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