Control/Query Meeting Minutes (Heading 1)



Regulated Clinical Research Information Management (RCRIM) Technical Committee Meeting Minutes

Teleconference

November 10, 2009

Attendees

|First Name |Last Name |Affiliation |E-mail Address |

|Anita |Benson |DataScene |anita@ |

|Alison |Buno |Pfizer |alison.buno@ |

|Kristi |Eckerson |Emory University |keckers@emory.edu |

|Joel |Finkle |Image Solutions, Inc. |joel.finkle@ |

|Myron |Finseth |Medtronic |myron.finseth@ |

|William |Friggle |Sanofi Aventis |William.Friggle@sanofi- |

|Patricia |Garvey |FDA |patricia.garvey@fda. |

|Scott |Getzin |Eli Lilly and Company |sgetzin@ |

|Norman |Gregory |FDA |norman.gregory@fda. |

|Joyce |Hernandez |Merck |joyce.hernandez@ |

|Peggy |Leizear |FDA |peggy.leizear@fda. |

|Mary |Lenzen |Octagon |mlenzen@ |

|Jay |Levine |FDA |jonathan.levine@fda.. |

|Steve |Sandberg |Mayo Clinic/Foundation |ssandberg@mayo.edu |

|Lise |Stevens |FDA |lise.stevens-Hawkins@fda. |

|Ed |Tripp |Edward S. Tripp and Associates |edward.tripp@ |

|Wendy |Ver Hoef |Scenpro |wverhoef@ |

|Steve |Ward |Lilly |stw@ |

|Julia |Zhang |Genzyme |Julia.Zhang@ |

I. Genomic CMETs that are constrained to serve the RCRIM models – Joyce Hernandez

HL7 CG CMETS might require some retrofitting work to be done to the CTLAB model in order to support them for clinical trial use. 

The CMETS were balloted on Sept, 2009.



Joyce would like to schedule a joint session for Clinical Genomics (CG) and RCRIM in Phoenix. CG is available on Q4 Wednesday. Currently we have BRIDG as a DAM scheduled in that slot. Ed will poll the projects to determine if we can amend the agenda to free up time in Q4 Wednesday.

It is expected that we will eventually need to modify the CTLab Message to accommodate the CMETS balloted in September.

I. COCT_RM970000 CMET – Anita Benson

Anita presented the above CMET as a CMET to be used to report adverse events during research studies. FDA intends to use ICSR, however, some in NIH, VA and CDC would like some specifics about the study included in the message, and therefore want this CMET. The potential of using the CDISC to content messages in conjunction with ICSR was raised; however, the sponsors may be concerned about the use of multiple messages.

Lise pointed out that ICSR has now included a choice box which would allow either the CMET to be used or only the minimal data to cross reference the information on the study.

There is no current project scope statement on this CMET. It was suggested that a project scope statement be developed and sent to the RCRIM and Patient Safety Listservers. Anita will develop a project scope statement. RCRIM will place review of the project scope statement on a future agenda at a time when the stakeholders can attend the call.

II. CDISC Content to Message Project Scope Revision – Jason Rock

[pic]

This agenda item was postponed until the November 24, 2009 teleconference.

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