Project Or Work Group Meeting Minutes s5

HL7 CIC Schizophrenia/MDD Call Minutes January 30, 2012 – 2:00 – 3:00 pm

Call-In Number: 1-770-657-9270 Participant Code: 283404

Attendees: Anita Walden Note Taker  Nate Reynolds  Meredith Nahm Mimi Kessler  Bob Zozus  Mead Walker Nidhi Gulati  Cindy Kluchar Kanya Manoj Claire Miller –

Agenda:  Attendance – Anita

MDD  Review of Action items  Status of Meeting between James, Cindy and Meredith  Questionnaire Extraction  CERC tentative meeting dates

Schizophrenia  Review of Action Items  Status of UML updates  Status of Activity Diagrams  Use Case updates

Discussions: MDD Status of UML updates-  Nate provided an example of how to associate the metadata elements with the data elements by using a reference class called MetaElement. Some elements require information such as date or source so creating a class with those associated attributes will reduce having to add them to each class. The below diagram demonstrates how an association is made to the reference class but not to the specific attributes within the reference class.  The modeling concept needs to be identified prior to the meeting if we want to generate the data elements from EA. The modeling concept is under discussion with the FDA and CDISC but we will not hold up drafting the model of the meeting doesn’t take place within the next month.

 A draft model of how to associate the attributes to the data elements is needed especially if there is more than one attribute or a subset of attributes that need association to a specific data element.

ACTION: Nate will draft a proposed solution to demonstrate how to associate a specific attribute from the MetaElement class to a specific data element. He will send this to Mead for review and input.

 Status of Meeting between James, Cindy and Meredith- This meeting has been set up for Friday. Anita will not be available for the meeting so she would like to cover this topic during the internal February 11th meeting.

ACTION – After meeting with Meredith James and Cindy will obtain the 2 or 3 questionnaires that were not on list and will send to Anita and Nidhi.

 Questionnaire Extraction - A meeting has been set up with Dianne Reeves on Thursday to discuss the collection of meta data and data elements for the questionnaires.  CERC tentative meeting dates – Invitations for clinical expert review committee have been drafted and will be sent out next week. We are targeting the second week of April to meet with the CERC to review the draft of data elements. This means we will need to have all of the data elements for MDD identified with draft definitions.

Schizophrenia

Status of UML updates - Nate has made the updates to the model based on the ballot reconciliation comments and dispositions. Other than the inclusion of the CDISC common classes and the DSM changes there are no other changes left to make. The DSM Axis will not be part of the new version coming out in May so the model should be changed to accommodate this change. The reference document will not be available until May.

ACTION: Nate: Make changes from HL7 discussion – Remove DSM AXIS.

Status of Activity Diagrams – Bob and Nate have reviewed the changes to the Activity model and Nate is working on the updates. We will discuss and questions to the revised model during next call.

ACTION: Nate will make the changes to the Activity Model and will send them to Bob on 31January. Use Case updates.

Use Case updates – Bob has created a use case diagram that he will send to Mimi for her review. Once she has provided feedback he will continue to develop the other use cases.

ACTION: Bob will send Mimi the new use case on Wed (today) and Mimi will provide feedback.

 Action Items Summary: MDD  Meredith will review spreadsheet and respond to Asad (Nidhi) with comments.  Nate will draft a proposed solution to demonstrate how to associate a specific attribute from the MetaElement class to a specific data element. He will send this to Mead for review and input.  After meeting with Meredith James and Cindy will obtain the 2 or 3 questionnaires that were not on list and will send to Anita and Nidhi.

  Schedule call for Nidhi, Dianne and Anita, regarding missing information on questionnaires. – Scheduled for Thursday, 1/31.  Cindy and James to meet with Meredith to continue progress. – Scheduled for Friday. SCHIZOPHRENIA  Nate Make changes from HL7 discussion – Remove DSM AXIS.  Nate will make the changes to the Activity Model and will send them to Bob on 31January.  Use Case updates.  Bob will send Mimi the new use case on Wed (today) and Mimi will provide feedback.

Meeting adjourned at 2:38 pm

Next Meeting Wednesday, February 13, 2013, 2:00 PM