Recent Posts From All Categories

Study Tagging Files: What’s the Right Duration for Study Metadata?

When submitting nonclinical study reports in regions using Study Tagging Files (STF), the duration of the study is one common piece of metadata that must be provided. The ICH eCTD STF Specification provides three options to choose from – short, medium, and long. But the ICH eCTD STF Specification doesn’t define the time periods covered by these three duration options.

Updated EU eCTD Validation Criteria

The European Medicines Agency (EMA) updated version 7.1 EU eCTD Validation Criteria will come into force September 1, 2018.  The changes in the validation criteria relate mainly to change requests received from regulatory bodies and taking experiences with version 6.1 into account. 

New 3rd Acknowledgement for ESG Users

Beginning September 4, 2018, a new third Acknowledgement for ESG users will be sent for all submissions sent to the CBER in eCTD format.

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.

Updates to Common FDA Forms

We recently posted about the August 2017 updates to common FDA...

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.

Creating an ESG Account: Tips for Success

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. It is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit along which submissions travel to reach the proper FDA Center or Office. Creating an ESG account requires many steps. This post provides helpful tips for the successful creation of your ESG account. 

NeeS: A Thing of the Past

With 2018 well underway, if you’re still not submitting in electronic Common Technical Document (eCTD) format in Europe, now is the time to transition. Non-eCTD electronic Submission or “NeeS” have been accepted for many years. However, they are becoming less common for National Procedures. Furthermore, at the end of this year, NeeS will be a thing of the past.  On 10 March 2017, the European Heads of Medicines Agenices (HMA) announced that eCTD will be mandatory for all regulatory activities in National Procedures as of January 1, 2019.