Project Scope-Clinical Trials Registration and Results

This vote was cencelled due to the nature of comments. RCRIM will revise and resubmitt.

Vote to approve the RCRIM Work Groups Clinical Trials Registration and Results project scope statement. Please enter your name and Work Group along with your vote. Only one vote per Work Group please. Any comments added through the poll should also be distributed to the DESD list server.

Summary: Number of participants: 11 Most popular option: Affirmative Votes in favor: 7 Comments: 2

• Ed Tripp (RCRIM) - Affirmative
• Helmut Koenig, II - Affirmative
• Jim McCain (Gov Project) - Affirmative
• Lise Stevens - Affirmative
• William Goossen PC - Negative
• Joy Kuhl - Affirmative
• Austin Kreisler - No vote
• Austin Kreisler (Lab) - Negative
• Robert Root OK - Affirmative
• Crystal Kallem (CIC) - Affirmative
• Rita Altamore (PHER) - Abstain

Comments Comment by William Goossen. (Saturday, September 27, 2008 5:07:28 AM EDT) Patient Care is in favor of the proposal. Still we vote negative since I believe that it is not made clear what the message standard will be. Is that going to be a HL7 v3 message? As HL7 WG it should be made explicit. In addition, PC discussed this topic with the group and it is not made clear if the Care Record R-MIM will be used. It is also not clear if the data elements will be specified as detailed clinical models, an agree JIC HL7 - CEN - ISO project proposal.

Comment by Austin Kreisler (Lab). (Thursday, October 9, 2008 3:27:23 PM EDT) Lab would like to see more clarification regarding how many stardards are to be developed in this area. The scope statement indicates one or more, these seems to be an openend project.

Orders and Observations has a conern regarding the relationship of this new work with material already published in 2.x by OO for Clinical Trials. OO wants to know if that 2.x material should be depricrted in favor of this new work, or if this new work will be consistent with existing material in 2.x.