Please use Oasis tools

All,

There has been much discussion emailed back and forth. In order to track items to be addressed by the TC, please remember to use the Issues List (a JIRA tool) on Oasis-Open.org. This enables committee members to log specific items for discussion, while requiring each comment to concisely specify the issue at hand.

Please also note that much of the email discussion has pertained to vocabulary essential to the eTMF domain. Phase II of the Charter is designated specifically to address the vocabulary essential to the eTMF domain. Phase I of the Charter is focused on the underlying technology architecture essential for software implementation and interoperability of the eTMF domain, independent of any software application.

While logged into Oasis, you can access the Issues List in the Oasis-Open JIRA system at https://tools.oasis-open.org/issues/browse/ETMF

Note you must also log in to JIRA (upper right side of page). Your JIRA login name and password are initially both the same as your OASIS login name. Please change the password when you first log in.

Once logged into JIRA Issues,

To add a new Issue select, “Create a new issue in project OASIS Electronic Trial Master File (eTMF) Standard TC”

Project = Oasis electronic Trial Master File (eTMF) Standard TC

Issue Type = Task (we’ll use Task to address comments)

Then, under Create Issue page

Summary = (KEEP IT SHORT) and format it with Subject – brief description (i.e. Metadata – Subject ID needs to be included in eTMF metadata)

Priority = Minor

Components = General

Assignee = (your name)

Environment = Specification

Description = (this is where your comments go, the more concise the better)

Proposal = (enter brief proposed action)

Resolution = (leave blank for now)

Select “Create” button

Do keep in mind that each issue logged will be emailed to the TC. As such, once an issue is logged, it would be most helpful not to reiterate issues already listed. This tool will help us all to track issues for attention by the TC while preventing email overload.

Thanks,

Jennifer Alpert Palchak, CEO

CareLex

Direct: 916-600-8388

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