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[[Category:RCRIM]] | [[Category:RCRIM]] | ||
Return to [[Regulated Clinical Research Information Management|RCRIM]] main page | Return to [[Regulated Clinical Research Information Management|RCRIM]] main page | ||
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==Project Scope== | ==Project Scope== | ||
| − | The project will extend the SPL model to develop a message that will allow transmission of a regulatory product information submission (labelling, listing, registration, unique device identifier and associated attributes as specified by the Global Harmonization Task Force (GHTF) ad-hoc working group on (UDI.) submissions | + | The project will extend the SPL model to develop a message that will allow transmission of a regulatory product information submission (labelling, listing, registration, unique device identifier and associated attributes) as specified by the Global Harmonization Task Force (GHTF) ad-hoc working group on (UDI.) submissions. The project will further provide references to other standards and external terminology resources required to populate the data elements defined in the standard. The work is based on existing work efforts: ISO/TC 215/SC WG6 N 547 (Health Informatics: IS#11615 Identification of Medicinal Products – Data Elements and Structure for the exchange of product information for drug dictionaries) and HL7 Structured Product Labeling and GHTF. |
This project will revise SPLr4 to leverage the data elements defined in the Common Product Model and reduce the SPL standard to the description of Header and Text information. | This project will revise SPLr4 to leverage the data elements defined in the Common Product Model and reduce the SPL standard to the description of Header and Text information. | ||
| + | |||
| + | . | ||
==Leadership== | ==Leadership== | ||
| + | SPL Chair: Terry Brunone, theresa.m.brunone@gsk.com | ||
| − | Project Facilitator: Myron Finseth | + | Project Facilitator: Myron Finseth, 763-526-3071, myron.finseth@medtronic.com |
| − | Domain Expert: Terrie Reed | + | Domain Expert: Terrie Reed, terrie.reed@fda.hhs.gov |
| − | Domain Expert: Anie Mathews | + | Domain Expert: Anie Mathews, anie.mathews@fda.hhs.gov |
| − | Domain Expert: Jackie Elkin | + | Domain Expert: Jackie Elkin, jackie.elkin@medtronic.com |
| − | Modeling Facilitator: Gunther Schadow | + | Modeling Facilitator: Gunther Schadow, gunther@pragmaticdata.com |
| + | |||
| + | . | ||
==Project Team Participation== | ==Project Team Participation== | ||
| − | [http://wiki.hl7.org/images/ | + | |
| + | [http://wiki.hl7.org/images/0/0b/How_to_get_connected_to_the_Medical_Product_Information2.doc How to get connected] | ||
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* First meeting is schedule for May 6, 2010 | * First meeting is schedule for May 6, 2010 | ||
* Meetings occur every other Thursday, 10:30 eastern | * Meetings occur every other Thursday, 10:30 eastern | ||
| − | * Telecom: 770-657-9270 . Passcode: 745896 | + | * Telecom: 770-657-9270 . Passcode: 745896 |
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. | . | ||
==SPLr5 Project Meeting Minutes== | ==SPLr5 Project Meeting Minutes== | ||
| − | [[ | + | * [http://wiki.hl7.org/images/2/2d/Medical_Device_Subteam_Minutes_Feb_24_2011.pdf Teleconference February 24, 2011] |
| + | * [http://wiki.hl7.org/images/1/1d/Medical_Product_Information_minutes_Feb_10_2011.doc Teleconference February 10, 2011] | ||
| + | * [http://wiki.hl7.org/images/f/f4/Medical_Product_Information_minutes_28_10_2010.doc Teleconference October 28, 2010] | ||
| + | * [http://wiki.hl7.org/images/7/70/Medical_Product_Information_minutes_21_10_2010.doc Teleconference October 21, 2010] | ||
| + | * [http://wiki.hl7.org/images/7/78/Medical_Product_Information_minutes_08_26_2010.pdf Teleconference August 26, 2010] | ||
| + | * [http://wiki.hl7.org/images/c/c4/Medical_Product_Information_minutes_05_06_2010b.doc Teleconference May 6, 2010] | ||
| + | |||
| + | ==HL7 October Ballot - SPL R5 Implementation Guide== | ||
| + | * [http://wiki.hl7.org/images/d/d2/SPLr5_IGv1.0_-_new.pdf New SPL R5 Implementation Guide] | ||
| + | * [http://wiki.hl7.org/images/3/3f/Compare_-_SPLr5_IGv1.0_-_new.pdf SPL R5 Implementation Guide compared to previous revision] | ||
| + | * [http://wiki.hl7.org/images/c/c0/SPLr5_IGv1.0_-_orginal.pdf SPL R5 Implementation Guide original version] | ||
==SPLr5 Project Working Documents== | ==SPLr5 Project Working Documents== | ||
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| + | * [http://wiki.hl7.org/images/6/67/SPLr5_ballot_overview.doc The Health Level Seven (HL7) May 2010 Ballot Overview] | ||
| + | * [http://wiki.hl7.org/images/8/8d/SPLr4_to_SPL(r5)_presentation_04062010.pdf SPL R4 to R5 presentation -- May 6, 2010.] | ||
==HL7 Ballot Materials - May 2010== | ==HL7 Ballot Materials - May 2010== | ||
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'''May 2010 – Project standards go to Ballot''' | '''May 2010 – Project standards go to Ballot''' | ||
| − | * Medical Product Information (SPLr5)DSTU | + | * Medical Product Information (SPLr5) DSTU |
* Common Product Model R10 DSTU | * Common Product Model R10 DSTU | ||
'''Oct 2010 – Project standards go to Ballot''' | '''Oct 2010 – Project standards go to Ballot''' | ||
| − | * Medical Product Information (SPLr5)DSTU | + | * Medical Product Information (SPLr5) DSTU |
* Common Product Model R10 DSTU | * Common Product Model R10 DSTU | ||
'''Jan 2011 – Project standards go to Ballot''' | '''Jan 2011 – Project standards go to Ballot''' | ||
| − | * Medical Product Information (SPLr5)DSTU | + | * Medical Product Information (SPLr5) DSTU |
* Common Product Model R10 DSTU | * Common Product Model R10 DSTU | ||
'''May 2011 – Project standards go to Ballot''' | '''May 2011 – Project standards go to Ballot''' | ||
| − | * Medical Product Information (SPLr5)Normative | + | * Medical Product Information (SPLr5) Normative |
* Common Product Model R10 Normative | * Common Product Model R10 Normative | ||
Latest revision as of 13:24, 8 May 2017
Return to RCRIM main page
Contents
Project Scope
The project will extend the SPL model to develop a message that will allow transmission of a regulatory product information submission (labelling, listing, registration, unique device identifier and associated attributes) as specified by the Global Harmonization Task Force (GHTF) ad-hoc working group on (UDI.) submissions. The project will further provide references to other standards and external terminology resources required to populate the data elements defined in the standard. The work is based on existing work efforts: ISO/TC 215/SC WG6 N 547 (Health Informatics: IS#11615 Identification of Medicinal Products – Data Elements and Structure for the exchange of product information for drug dictionaries) and HL7 Structured Product Labeling and GHTF. This project will revise SPLr4 to leverage the data elements defined in the Common Product Model and reduce the SPL standard to the description of Header and Text information.
.
Leadership
SPL Chair: Terry Brunone, theresa.m.brunone@gsk.com
Project Facilitator: Myron Finseth, 763-526-3071, myron.finseth@medtronic.com
Domain Expert: Terrie Reed, terrie.reed@fda.hhs.gov
Domain Expert: Anie Mathews, anie.mathews@fda.hhs.gov
Domain Expert: Jackie Elkin, jackie.elkin@medtronic.com
Modeling Facilitator: Gunther Schadow, gunther@pragmaticdata.com
.
Project Team Participation
- First meeting is schedule for May 6, 2010
- Meetings occur every other Thursday, 10:30 eastern
- Telecom: 770-657-9270 . Passcode: 745896
.
SPLr5 Project Meeting Minutes
- Teleconference February 24, 2011
- Teleconference February 10, 2011
- Teleconference October 28, 2010
- Teleconference October 21, 2010
- Teleconference August 26, 2010
- Teleconference May 6, 2010
HL7 October Ballot - SPL R5 Implementation Guide
- New SPL R5 Implementation Guide
- SPL R5 Implementation Guide compared to previous revision
- SPL R5 Implementation Guide original version
SPLr5 Project Working Documents
HL7 Ballot Materials - May 2010
- Medical Product Information (includes Drugs, Devices, Biologics, Veterinary Products) (SPLr5) - Go to Regulated Products / Structure Product Labeling (SPL)
- Common Product Model - Go to Regulated Products / Common Product Model
.
HL7 Voting Introduction
or
- HL7 Voting Background - Part 1
- HL7 Voting Ballot Desktop - Part 2
- HL7 Voting Understanding the Ballot Materials - Part 3
- HL7 Voting Casting Ballot - Part 4
.
Overall Project Timeline (subject to change)
May 2010 – Project standards go to Ballot
- Medical Product Information (SPLr5) DSTU
- Common Product Model R10 DSTU
Oct 2010 – Project standards go to Ballot
- Medical Product Information (SPLr5) DSTU
- Common Product Model R10 DSTU
Jan 2011 – Project standards go to Ballot
- Medical Product Information (SPLr5) DSTU
- Common Product Model R10 DSTU
May 2011 – Project standards go to Ballot
- Medical Product Information (SPLr5) Normative
- Common Product Model R10 Normative
