2004-05-14 RCRIM Teleconference Minutes

2004-05-14 RCRIM Teleconference Minutes

Regulated Clinical Research Information Management Technical Committee of HL7

2004-07-23 Teleconference Minutes


Bill Friggle (Sanofi-Synthelabo)
Barry Brown (Mortata Instrument)
Bob Hizer (Eli Lilly and Company)
Chris Tolk (Bayer Corporation)
Fred Wood (Procter & Gamble Pharmaceuticals)
Ali Rashidi (AHRQ)
Joyce Hernandez (IBM)
Linda Quade (Eli Lilly and Company)
Smita Hastak (National Cancer Institute)
Lisa Perry (Doctor Notes)
Michael Gould (GlaxoSmithKline)
Note: on the teleconference attendee list, you company is stated as in the HL7 membership directory unless you say otherwise during the roll-call.

NOTE: Bill Friggle, Joyce Hernandez, Linda Quade and “All RCRIM Members” have been assigned Action Items during this meeting.

Audit Trail Discussions on HL7 ListServers:

Bob Hizer noted there has been lively discussion on some of the HL7 listservers about how to include audit trail information in an HL7 message. This is information like who changed a particular data point value, when, under what authority, etc. Bob noted that SDS currently has no audit trail ability, but Steve Wilson of FDA has expressed concern, and indicated this type of information should be submitted with trial data. Some sponsors have built this into their proprietary submission systems, but as we move to commercial software we need to be sure the standards they use include this capability.

RCRIM members should be monitoring and contributing to this discussion from two perspectives:

  1. to clarify the actual requirements for audit trail information, and underscore the importance of such information
  2. to participate in the structuring of an HL7-wide solution for this. From this perspective, explaining how solutions already in place in the clinical research environment (e.g. the ODM approach) could also be applied in HL7 messaging would be a great contribution.


  • Joyce will contact Steve Wilson for more information on FDA thinking. She will also alert him to the current email thread and encourage him to get FDA personnel involved.
  • Linda will put this thread on the RCRIM Listserver.
  • RCRIM members will review the thread and participate in accordance with their type of interest (business or technical)

New Target Environment for Trial Data?

Bill Friggle noted recent moves in Congress to expand the scope of trial data that must be reported publically, and asked whether we should be discussing this, influencing the discussion and preparing for this possibility.


  • Bill will try to summarize the important considerations and introduce this as a discussion on the RCRIM listserver.

Status of CT Laboratory Message

The message for Periodic Reporting of Clinical Trial Laboratory Data (CTLab) passed membership ballot several cycles ago, and is awaiting ANSI approval, which should be received anytime. RCRIM also has approved a project to finalize the message for implementation. Phil Pochon and Linda Quade are working on an implementation guide. When the first workproducts for that are ready, they will be circulated to RCRIM and project teleconferences will be held. Right now, Phil has done the first mapping to the CDISC standard. Linda is working on confirming the mapping, and creating definitions of individual XML attributes and explanations of their usage.

Questions on AnnotatedECG standard

Barry Brown brought in a series of questions about implementation of the aECG standard (ANSI approved). Most of these questions involved vocabulary, and underlined our need to address vocabulary immediately if our messages are to be interoperable. Linda pointed out the difficulty usually encountered in getting broad agreement on vocabulary, and therefore the HL7 decision to disassociate ballot passage from nailing down specific code sets. Nevertheless, many agreed the time has come for us to focus on specific value sets.

Carol Bean has agreed to be RCRIM Vocabulary Facilitator. Ali suggested we try to address vocabulary across both RCRIM and Patient Safety together, rather than separately. There was general agreement that this is a good idea. We also noted that CDISC has a Terminology Team headed by Susan Bassion which might be encouraged to take up HL7 vocabulary needs immediately, and that there are many existing vocabularies published. We should look to these whenever possible, especially to the CDISC efforts.

Value Sets (code lists) generally become an issue when a project begins to address implementation. The appropriate way to introduce a missing value set is through a vocabulary proposal prepared by the Vocabulary Facilitator and approved by the Committee. Then it goes to the HL7 Harmonization Committee, which decides whether to include it by reference or to actually copy it into the HL7 vocabulary system.

It was also noted that for certain implementations, some value sets are mandated by legislation or regulation. This means we need to have representation from those who set these policies when we establish vocabulary domains in a message, and to influence those bodies when appropriate to adopt value sets suitable for our messaging needs. It also means we cannot constrain the vocabulary too tightly in the standard itself, since these constraints cannot be loosened – they can only be tightened – by individual implementations. This is another reason for disassociating ballot requirements from vocabulary purity in HL7.

This discussion also brought up the general idea of Implementation Guides again – specifically whether HL7 plans to have HL7 Implementation Guides for the V3 standards, or to rely on the major implementers to provide such guides.


  • Linda will contact Carol Bean and ask her to join the next RCRIM telecon (August 6) to talk about our vocabulary issues and how we should proceed to resolve them.
  • Linda will contact the HL7 Implementation committee with the specific question about Implementation Guides for V3 – will HL7 create a general guide, or will we rely on more-or-less local guides?

Motion for adjournment by Linda Quade was seconded by Bill Friggle

Meeting was adjourned 12:20 EDT

respectfully submitted

Linda Quade, presiding chair

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