Phase 2 Part B and Phase 3

The files and instructions needed to conduct the second portion (Part B) of Phase 2 of ETICS III  – the review/analysis portion, and Phase 3 (adding one more sequence) – are now available.

If you are a vendor of a tool for the review/validation/importing of eCTD sequences, you can participate in Part B.  Regulatory authorities are invited to participate as well.

If you are a vendor of a tool for the building of eCTDs, you can participate in Phase 3. The instruction spreadsheets for each region contain instructions for both phases. Each regional 7-zip file is organized in a similar manner. If you do not have a tool for extracting 7-zip files, you may download this open source free tool:

Download the 7-zip files for each of the 3 regions in the study below:

CA: Click here to download.

EU: Click here to download.

US: Click here to download.   <<< Note – Phase 3 instructions were corrected October 12, 2012

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Phase 2 Instructions and Sample Files

The files and instructions needed to conduct the first portion of Phase 2 of ETICS III  – the building portion – are now available.  Each regional zip file contains a PDF file named “start here…” with further details.

Instructions regarding the next steps – uploading your completed submissions to the FTP server – will be provided at the appropriate time.

Download the zip files for each of the 3 regions in the study:

CA: Click here to download.

EU: Click here to download.

US: Click here to download.

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ETICS Phase 1 Results Made Public

The reports created by the 3 regional IRISS ETICS teams were written in such a way that the identity of participants is encoded.  A single comprehensive report for each region was issued. These are now being made available to the public and can be viewed or downloaded below.

The ETICS Team invites developers of new tools or established vendors who are making major changes to their tools to use the materials provided here as a test bed for confirming the correct operation of these tools.

The sample eCTDs along with the detailed description of the intentional error in each sample and the expected outcome provides software developers with the resources they need to evaluate the compliance of their tools.

Sponsors may wish to use these same resources to test the tools that they currently use or perhaps are evaluating.

Links to Resources

Region Sample eCTDs Phase 1 Report Other
CA CA Samples CA Report & Sample Decode
EU EU Samples EU Report & Sample Decode
US US Samples US Report US Sample Decode
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ETICS III Phase 1 Analysis is Under Way

Phase 1 test results

  • 7 vendors and 4 agencies completed Phase 1.
  • 6 vendors who had enrolled did not complete Phase 1, although 1 indicated that they did not have a validation tool and will be participating in Phase 2.
  • Analysis by the regional teams is proceeding. Target date for completion of the analysis is end of August.

Phase 2 Is Now in the Planning Stage

Stay tuned for further information in the coming weeks.

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ETICS III Phase 1 Begins Today

For the latest version of this document and other documents related to ETICS, please access the ETICS web site at

The objective of Phase 1 is to provide data on tool interoperability and compliance. In Phase 1, sample sequences prepared by the IRISS ETICS Team are provided to the Phase 1 participants to determine how eCTD tools deal with variations commonly found in samples, detect known problems and provide useful messages to the user. Each participant will provide to the ETICS team a listing of any issues or problems with each of the sequences they process.

Background and Reminder
The analysis results specific to your tool(s) will be shared confidentially with you in a manner that hides the identity of competitor’s tools. This will enable you to identify strengths and weaknesses of your tool(s). Although the names of participating tools and products used in the study will be published, study results will be analyzed and reported in an anonymous, generalized manner (e.g. a table showing type of problem encountered and incidence rate of problem).

The sample eCTD files have been prepared in 7-zip format due to the high level of compression provided by that format. If your archive tool does not support the 7-zip format, please see for the open source tool.
All of the files and instructions have been posted on the web site here:


A total of 3 files have been prepared in 7-zip format, one for each region in this study. Within each file, data collection forms and instructions specific to that file are provided.

As you complete the Phase 1 steps, if you have questions, please use the email addresses for the appropriate region:

US –
EU –
CA –

Completed materials should be uploaded to the FTP server in folders provided.

Recording the Evaluation Results
We feel that it is in the interest of all study participants, the pharmaceutical industry, and regulators if the evaluation of each sample is performed fairly. It would not be useful to employ additional software utilities to examine the samples in order to detect any possible problems, nor do we wish that you manually examine the samples. If, for example, the tool you are testing is a review tool, the sample eCTD should be loaded and any errors generated by your review tool should be noted. We request that you categorize the errors as Hard or Soft errors on the spreadsheets accompanying each group of regional samples. An example of a Hard error is one which stops the loading process. An example of a Soft error is one which issues a warning but allows the loading process to proceed.
When recording errors, please do not record multiple errors of the same type per sequence. For example, if invalid characters were found in every file name in a sequence, the error should be summarized as “Invalid characters in multiple file names”. While it would be interesting to see how detailed your tool’s error reporting is, it will take too much time to review such detailed listings during our analysis.

The deadline for submitting your Phase 1 work to the FTP server is June 30th.

Downloading Samples
The sample files and instruction spreadsheets may be downloaded at any time from the web site: .

Please send general requests for help to

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