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Jeffrey Shuren, IMDRF Chair RPS Beta Testing Document - PDF (1.2Mb)

赵静曼 6/12/2022 浏览 143 Jeffrey Shuren, IMDRF Chair 世界

标准简介

RPS Beta Testing Document - PDF (1.2Mb)[附网盘链接]是于16 May 2014发布的GHTF标准，适用于世界。

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RPS Beta Testing Document - PDF (1.2Mb)[附网盘链接]
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IMDRF RPS Working Group, Final

1.0 Introduction

Regulated Product Submission (RPS) is a messaging standard produced by HL7 that is designed

to enable electronic submission of regulated products – including drugs, devices, food and

veterinary medicines. The IMDRF RPS Working Group is evaluating the Regulated Product

Submission (RPS) standard to assess whether the standard will meet medical device needs as a

harmonized electronic submission format.

As part of the IMDRF evaluation the working group is performing testing of medical device

submission scenarios to verify the RPS standard can effectively convey required submission

information. This document summarizes information from the first round of IMDRF Beta

Testing efforts.

2.0 Scope

This document summarizes the Beta Testing process and results from the IMDRF RPS Working

Group efforts prior to the September 2013 RPS Ballot within HL7. Testing efforts are still

ongoing. Subsequent test efforts and results will be summarized in additional documents to be

released at a later date.

3.0 References

HL7 RPS Draft Standard for Test Use (DSTU)

4.0 Definitions

RPS: Regulated Product Submission. An HL7 standard currently being tested by the IMDRF

RPS Working Group.

HL7: Health Level 7.

DSTU: Draft Standard for Trial Use.

Test Case Scenario: A collection of 3 – 5 test cases that are tested together in a particular order.

The test case scenario follows a business process that is being tested.

Message: The XML file accompanying the documents contained in the submission unit. The

XML file structure is defined by the RPS standard and provides information about how the files

included should be reviewed.

Submission Unit: A package of documents to support a regulatory activity that is sent and

received together. In paper terms, this is the fed-ex box containing a packet of information sent

from industry to the regulator. In RPS terms, this includes the submissionUnit.xml file as well as

the accompanying submission files.

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