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.

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

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.

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 http://www.7-zip.org/ for the open source tool.
Approach
All of the files and instructions have been posted on the web site here:

CA: www.etics.us/etics3/phase1/CA.7z
EU: www.etics.us/etics3/phase1/EU.7z
US: www.etics.us/etics3/phase1/US.7z

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 – etics-us@iriss-forum.org
EU – etics-eu@iriss-forum.org
CA – etics-ca@iriss-forum.org

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.

Schedule
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: www.etics.us .

Help
Please send general requests for help to etics@iriss-forum.org