HL7 RCRIM Working Group Meeting Minutes



Tuesday Q1 CRFQ Ballot Reconciliation

Attendees

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

|Becky |Angeles |ScenPro |bangeles@ |

|Michael |Brennan |Johnson and Johnson |mbrenna3@its. |

|Ed |Helton |NCI |heltone2@mail. |

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

|Masaaki |Hirai |HL7 Japan |Masaaki_Hirai@ |

|John |Kiser |Abbott Laboratories |john.kiser@ |

|Koji |Shomoto |JPMA |jpma.denshi@ |

|John |Speakman |NCI |john.speakman@ |

|Sadamu |Takasaka |HL7 Japan |s-takasaka@m7.gyao.ne.jp |

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

|Marti |Velezis |Sonrisa Consulting |marti.velezis@ |

|Steve |Ward |Lilly |stw@ |

I. CRFQ Ballot Reconciliation Marti Velezis

The summary of the balloting is in the table below.

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|  |Aff. |Neg. |Abst. |NV |

|Affiliate |0 |0 |28 |1 |

|Consultant |1 |1 |4 |1 |

|Government/Non-Profit |8 |0 |2 |0 |

|Payor |0 |0 |1 |0 |

|Pharmaceutical |2 |3 |1 |0 |

|Provider |14 |3 |16 |2 |

|Vendor |0 |0 |18 |3 |

|Totals |25 |7 |70 |7 |

|% of Votes |22.94% |6.42% |64.22% |6.42% |

|Quorum |93.58% |

|Approval |20 |

The consolidated comments spreadsheet lists all votes cast and comments or reference to the uploaded comment spreadsheet.

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The spreadsheet below is a consolidation of all comments uploaded via spreadsheet.

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The word document below was submitted with HIPAA and Security Concerns.

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There were about 19 comments. Marti walked through the spreadsheet.

Motion by Ed Helton, second by Michael Brennan to accept reconciliation recommendations and dispositions as presented by Marti.

For 9

Against 0

Abstain 1.

II. Work Group Health Ed Tripp

The current Work Group Health is show in the file below.

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Changes to metrics approved by TSC.

a) Wiki presence will no longer be a metric

b) Participation in harmonization activities will now be measured

c) SWOT must be current (approved every 3 years)

d) No minutes posted will result in “RED” regardless of other metrics

e) RED Work Groups will be a standing agenda item for all Steering Division Meetings.

I. PBS Metrics Ed Tripp

The current Work Group Health is show in the file below

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Status of PBS metrics will be reviewed by DESD whenever a new PSS is submitted. Intent is to determine if WG has the capacity to take on a new project.

Tuesday Q2 Joint session with O&O, Pharmacy IDMP and CPM

This session was hosted by Orders and Observations. See Orders and Observations minutes for attendance information and minutes.

Tuesday Q3 PSUR – Joint Session with Patient Safety

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

|Michael |Brennan |Johnson and Johnson |mbrenna3@its. |

|Tim |Buxton |EMA |tim.buxton@ema.europa.eu |

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

|Peter |Goldschmidt |Agency for Healthcare Research and Quality |pgg@ |

|William |Gordon |Oracle |william.gordon@ |

|William |Gregory |Pfizer |gregow@ |

|Nicholas |Halsey |European Medicines Agency |Nick.Halsey@ema.europa.eu |

|Ed |Helton |NCI |heltone2@mail. |

|John |Kiser |Abbott Laboratories |john.kiser@ |

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

|Junko |Sato |Pharmaceuticals & Medical Devices |sato-junko@pdma.go.jp |

|John |Speakman |NCI |john.speakman@ |

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

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

|Coco |Tsai |FDA |Yiying.tsai@fda. |

|Mead |Walker |Mead Walker Consulting |dmead@ |

I. Update Mead Walker

PS had a discussion on PSUR’s and Public Health Reporting

II. Public Health Reporting Lise Stevens

There is an effort for a harmonize construct for public health reporting. There are 5 categories: Adverse Events, Child health, chronic disease, communicable disease, infrastructure quality and research. Project is currently modeling data, identifying standards and gaps in the standards. Work is being done jointly with PHER. Scope was EHR reporting for public health (individual case vs. population reporting), however the research portion of infrastructure quality and research addresses groups and possibly populations.

II. PSUR Nick Halsey

Nick presented the following:

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FDA wants to participate with this effort.

GVP (Good Vigilance Practice) is being drafted as guidance to meet the EU legislation.

First wave of new guidelines will be published in February. When you submit a ePSUR you will be submitting updates to eRMPs’ FDA will bring requirement for both safety reporting and risk management.

The future plan is to have all PSUR’s by active substance rather than by product. There will be a single date for all sponsor companies. Line listings will not be required.

The use of a Structured Document will aid the reviewer’s job.

There will be an alignment between the ICH E2C and the DSUR. Following that there will be an update to the DSUR and possibly the clinical trials directive.

Patient Safety will use the ICH Step 3 document as well as requirements gathered by FDA/EMA. PS WG would start with a class or activity diagram for user to map requirements to.

It was agreed that Patient Safety and RCRIM would meet for 2 consecutive quarters in a joint session hosted by RCRIM for the purpose of identifying requirements for PSUR’s and Risk Management Plans

Tuesday Q4 RPS Ballot Reconciliation

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

|Becky |Angeles |ScenPro |bangeles@ |

|Michael |Brennan |Johnson and Johnson |mbrenna3@its. |

|Tim |Buxton |EMA |tim.buxton@ema.europa.eu |

|Pam |Cafiero |Boehringer Ingelheim Pharmaceutical |pam.cafiero@boehringer- |

|Joeseph |Cipollina |Bristol-Myers Squibb |joseph.cipollina@ |

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

|Gary |Gensinger |FDA |gary.gensinger@fda. |

|Mark |Gray |FDA |mark.gray@fda. |

|Ed |Helton |NCI |heltone2@mail. |

|Masaaki |Hirai |HL7 Japan |Masaaki_Hirai@ |

|Kohki |Hirano |JPMA |hirano-kohki@pmda.go.jp |

|John |Kiser |Abbott Laboratories |john.kiser@ |

|Harv |Martens |ING America |harvmartens@ |

|Hitoshi |Matsui |JPMA |hmatsui@cac.co.jp |

|Klaus |Menges |Bfarm |k.menges@bfarm.de |

|Mary |Padgett |FDA |mary.padgett@fda. |

|Jason |Rock |Global Submit |jason.rock@ |

|John |Speakman |NCI |john.speakman@ |

|Sadamu |Takasaka |HL7 Japan |s-takasaka@m7.gyao.ne.jp |

|Taku |Watanabe |PMDA |watanabe-taku@pmda.go.jp |

I. RPS Ballot Reconciliation Jason Rock

The summary of the balloting is in the table below.

| |Aff. |Neg. |Abst. |NV |

|Affiliate |0 |15 |13 |1 |

|Consultant |2 |1 |2 |1 |

|Government/Non-Profit |17 |0 |1 |1 |

|Payor |0 |0 |1 |0 |

|Pharmaceutical |12 |0 |1 |2 |

|Provider |18 |1 |15 |2 |

|Vendor |5 |1 |19 |3 |

|Totals |54 |18 |52 |10 |

|% of Votes |40.30% |13.43% |38.81% |7.46% |

|Quorum |92.54% |

|Approval |44 |

The consolidated comments spreadsheet lists all votes cast and comments or reference to the uploaded comment spreadsheet.

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The spreadsheet below is a consolidation of all comments uploaded via spreadsheet.

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Notes for all Ballot Comments discussed during Q4 RPS Ballot Reconciliation:

Note: Not all Ballot Comments will be discussed during this quarter, Keith Thomas’ comments will be discussed Wednesday Q1.

Number 1- 11: Issue is with the numbering of the elements by the HL7 Schema generation tool

Option 1 – Deal with it – and accept the inconsistency in the model and schema

Option 2 – Change it in the schema (schema is non-normative – so the changes can be made, and this will need to be manually updated until the generation tool is updated by HL7)

Option 1 is acceptable at this time.

Number 12 – Update with the model can be made to display the missing information for the negationIND

Number 13 – Transmission Wrapper requires the “SUBJ” value for the TypeCode (Element = ControlActProcess@typeCode

Option 1: Comment can be forwarded to the WG that manages the model/schema

Option 2: Make changes to the schema

No decision made – explanation was satisfactory to the commentor

Number/Row 19

Acknowledge this is the 3rd Draft of RPS R2 – this may not be able to be changed post-ballot

2.2.1.3 – Ballot Materials – Note portion of the storyboard; the request is to remove the comment – does the statement provide any value.

Group felt that this gives someone not familiar to the regulatory product submission process more domain information.

Decision: Not persuasive, keep the storyboards as is.

Number 36/Row 25

2.2.2.14 (Replacing multiple files with one file) – Redundant with 2.2.2.7 (Replacing a file and an addendum)

Decision: Keep both of the storyboards

Number 48/Row 37 – 2.2.5.11 – EU Storyboard

Decision – Considered No Action Required; the scenario may happen, but there are not changes that will be made to the text of the scenario. Need to consult Regional Implementation Guides.

Number 54/Row 43

2.4.3 – Annual Reports and Periodic Reports – should these be referenced in the

Decision: Pending discussion with submitter to clarify the issue and address at the telecon. Jason to send an email to Joel.

Number 55/Row44 – How do you reference one application is related to two different submissions in a submission unit.

Response – provide the Application.id@root for each submission.

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