2012-02-14 RCRIM Call Minutes

Return to RCRIM Teleconference Minutes and Agendas

Meeting Information

HL7 RCRIM Agenda Location: Dial: 770-657-9270 Passcode: 7485962# WebEx Info: Go to https://estripp.webex.com/estripp/j.php?ED=129183437&UID=0&PW=NNzQ1Nzg4NGZj&RT=MiM3 If requested, enter your name and email address. If a password is required, enter the meeting password: RCRIM		Date: 2012-02-14 Time: 10:00-11:00 am Eastern Time
Facilitator	Ed Tripp	Note taker(s)	Ed Tripp
Attendee	Name	Affiliation
x	Becky Angeles	ScenPro
x	Michael Brennan	Johnson and Johnson
x	Ed Helton	NCI
x	Bron Kisler	CDISC
x	Jay Levine	FDA
x	Armando Oliva	FDA
x	Steve Sandberg	ScenPro
x	Ed Tripp	Edward S. Tripp and Associates
x	Mead Walker	Mead Walker Consulting
x	Steve Ward	Lilly
Quorum Requirements Met: YES
quorum for RCRIM is 8 plus a co-chair

Agenda

Agenda Topics

1. Agenda review and approval
2. Approve meeting minutes from 2012-01-03 RCRIM Call Minutes
3. Discuss proposed edit to Wednesday Q1 WGM minutes
4. Approve meeting minutes from San Antonio WGM
5. Review Agenda for WGM
   1. discuss approache to Information mapping and gap/impact analysis for clinical process
6. Other Items

Supporting Documents

• 2012-01-18 RCRIM WGM Minutes San Antonio

Minutes

Minutes/Conclusions Reached:

1. Agenda review and approval

   No additional agenda items

2. Approve meeting minutes from 2012-01-03 RCRIM Call Minutes

   Affirmative - 9

   Opposed - 0

   Abstain - 1

   Minutes approved.

3. Discuss proposed edit to Wednesday Q1 WGM minutes

   Upon review of the WGM Minutes for Wednesday Q1 at San Antonio, it was noted that the recommendation for disposition is not appropriate. Per the instructions on the reconciliation sheet "6. Referred and Tracked. This should be used in circumstances when a comment was submitted to your WG in error and should have been submitted to another WG. If you use this disposition you should also select the name of the WG you referred the comment to under the Column "Referred To"."

   Ed Tripp suggested the following note be added to the Meeting Minutes:

   NOTE: Upon review of the minutes it was noted that “Referred and Tracked” is not an appropriate disposition. At the teleconference on February 14, 2012, the RCRIM WG amended the minutes to state the comments will be marked “Consider for Future Use”. This relates to the three topic areas from Keith Thomas. The RPS team has been informed of the change.

4. Approve meeting minutes from San Antonio WGM

   Motion by Armando Oliva, seconded by Michael Brennan to approve all minutes for the San Antonio WGM with the changes to Q1 Wednesday noted above.

   Affirmative - 10

   Opposed - 0

   Abstain - 0

   Minutes approved.

5. Review Agenda for WGM

   RCRIM_Working_Group_Meeting_Agendas#Vancouver.2C_BC.2C_Canada.2C_Working_Group_Meeting_May_2012

   1. discuss approach to Information mapping and gap/impact analysis for clinical process

   The team discussed different approaches to working on an information map that highlights where there are needs for information exchange. Mead Walker and Michael Brennan made several suggestions including starting with a High Level process that describes a drug product life-cycle, identifying where exchanges exist and potential opportunities for exchanges. We should document the "why" for the exchange and whether it is uni-directional or bi-directional.

   Mead Walker, Micheal Brennan and Ed Tripp volunteered to work on a first pass, high level map and bring it back to the RCRIM WG in 4 weeks.

6. Other Items

   None

• Adjourned 10:37 a.m. Eastern.

Meeting Outcomes

Action Item	Owner	Due Date
Develop a first pass, high level process map of the drug development life-cycle as a starting point for identification of information exchange points	Michael Brennan, Ed Tripp, Mead Walker	3/13/2012

Next Meeting Preliminary Agenda Items

1. Agenda review and approval
2. Approve meeting minutes from 2012-02-14_RCRIM_Call_Minutes
3. Other Items

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