# Presentation: 248945

## Electronic ICSRsThe US Pilot

- DIA 36th Annual Meeting
- San Diego, CA
- June 13, 2000

## Electronic ICSRs US Pilot

- To report the progress of initiative to transmit electronically individual case safety reports (ICSRs) to FDA
- Topics:
- CDER Pilot Perspective, Deborah Yaplee, FDA
- FDA Gateway Perspective, Elizabeth Chew, FDA
- Industry Perspective, Oliver Mellet, Merck & Co.

## Electronic ICSRs US Pilot:  CDER Pilot Perspective

- DIA Annual 36th Meeting
- San Diego, CA
- June 13, 2000
- Deborah Yaplee, U.S. Food and Drug Administration

## ELECTRONIC ICSR US PilotIntroduction

**ELECTRONIC ICSR US Pilot*****Introduction***

## ELECTRONIC ICSR US PilotCDER: Functions to Implement

## ELECTRONIC ICSR US PilotCDER: Processing AE data

**Task:  Process E2B/M2 AE Reports**
- Receive, process and send E2B/M2 files
- MedDRA
- Paper, physical media, or electronic gateway
- M2 acknowledgement

## ELECTRONIC ICSR US PILOTCDER: Storing Reports

**Task:  Store Reports**
- Load retrieved files in AERS database
- Distribute to reviewers
- Safety Evaluators
- Epidemiologists
- Medical Officers

## ELECTRONIC ICSR US PilotCDER: Agency Requirements 

**Task:  Require Changes**
- Eliminate Paper Submissions
- ANPRM - Electronic Reporting (11/98)
- Upcoming Proposed Rule
- Interim FDA Electronic Submissions Docket
- New Guidance with New Regulations

## ELECTRONIC ICSR US PilotCDER: Agency Requirements (cont’d)

**Task:  Require Changes**
- Shift Risk Assessment from New Drug Review Staff to OPDRA
- Eliminate paper distribution
- Implement Electronic Distribution
- Provide On-line Safety Evaluation of Electronic Submissions

## ELECTRONIC ICSR US PilotCDER: Project Status

- Current Participants: FDA, Bristol-Myers Squibb, Glaxo SmithKline, Merck, Pharmacia, Roche, Sanofi-Synthelabo, Pfizer, DuPont Pharmaceuticals, J&J Pharma Group, Parke-Davis, Eli Lilly, AstraZeneca

## E*Prompt Phases

***Development/Test***

***Pilot Production***

***Production***

***July 1, 2000***

***November 1, 2000***

***Industry***

***FDA***

- Development of Software
- User Accepting Testing with Industry Test Files
- Drafting of Guidance Rules for Submissions

- Submission of DTD 2.0 SGML  Files  with EDI headers

- Processing of Production Ready Files
- Validation of Accuracy, Completeness, and Processing of Data
- Test Gateway
- Development of Business Rules as Needed

- Submission of Production Ready Files
- Receipt and Processing of Acknowledgements

- Submission of Production Files
- Address Issues with Unsuccessful Files

- Processing of Production Files Through Gateway
- Provide Feedback on Unsuccessful Files
- Provide Routine Quality Assurance Reviews

- Users Accept Software

- Submit Test Files
- Trading Partner Agreement Approved

- Process Files
- Guidances are in place
- Manual Procedures in place

- Error Free or Minimum Error Files
- Receipt and Processing of Acknowledgement Files

## ELECTRONIC ICSR US PilotCDER: Development/Test Phase

- Development of Software
- Tool to Validate Message Structure
- Tool to Validate Message Transmission Protocol
- Drafting of FDA Guidance Rules for Electronic Submissions of ICSRs
- Format
- Procedures

## ELECTRONIC ICSR US PilotCDER: Pilot Production Phase

- Processing of Production Ready Files
- Acknowledgment
- Load into Database
- Validation of Accuracy, Completeness, and Processing of Data
- Gateway Testing
- Development of FDA Internal Business Rules as Needed
- Exception Handling

## ELECTRONIC ICSR US PilotCDER: Production Phase

- Processing of Production Files Through Gateway
- Provide Feedback on Unsuccessful Files
- Future Participants Contact AERS Electronic Submission Coordinator at aerspilot@cder.fda.gov

## ELECTRONIC ICSR US PilotCDER: Next Steps

- Automated AERS Acknowledgments
- Electronic Attachments
- Processes and Procedures
- Periodic Reports

## ELECTRONIC ICSR US PilotCDER: Additional Information

- www.fda.gov (FDA)
- www.fda.gov/cder (CDER)
- www.fda.gov/cder/aers/regs.htm (AERS)
- Reporting regulations, guidances, and updates
- www.fda.gov/cder/aerssub (PILOT)
- www.fda.gov/medwatch/report/mfg.htm (MEDWATCH)
- Reporting regulations, guidances, and updates
- aerspilot@cder.fda.gov (EMAIL)

## ELECTRONIC ICSR US PilotCDER: Additional Information(cont’d)

- www.fda.gov/oc/electronicsubmissions/interfaq.htm (GATEWAY)
- Draft Trading Partner Agreement, gateway FAQs
- www.fda.gov/cder/present (CDER PRESENTATIONS)
- www.ich.org (ICH home page)
- www.fda.gov/cder/m2/default.htm(M2)
- ICH ICSR DTD
- Implementation Manuals
- www.meddramsso.com (MedDRA MSSO)

## Electronic ICSRs US Pilot:FDA Gateway Perspective

- DIA 36th Annual Meeting
- June 13, 2000
- San Diego, CA
- Elizabeth Chew, Office of the CIO
- U.S. Food and Drug Administration

## Presentation Outline

- Release 1.1 Overview
- Capability
- Gateway Components
- “Trading Partner” Information Package
- How to get started in order to trade information with the FDA Gateway
- Lessons Learned from Expedited Reporting Pilot

## FDA ESTRI Gateway Capability

**E***lectronic* **S***tandards* *(for the) ***T***ransmission (of) ***R***egulatory* **I***nformation*
- Core Set of Open Standards
- Applies to Regulatory Bodies and Industry
- Templar Specifically Recommended by ICH, but not Mandated by the FDA
- Allows 2-Way Interchange

## FDA ESTRI Gateway Capability

- FDA has built an EDI-based Gateway System to Transfer Regulatory Information Electronically via the Internet.
- First FDA “User” is the CDER AERS System For Exchange of Post-marketing Adverse Events 15 day Expedited Reports
- Project leverages ICH Standardization Efforts

## FDA ESTRI GatewayCapability

**Key Functionality**
- Gateway receives, authenticates trading partner information, and places file into defined area for AERS retrieval
- Requirements for Two-Way exchange are completed to support the ICH E2B/M2 EWG standards published on March 8, 1999
- The Gateway is NOT a receipt point for physical electronic media. (Continue to use respective Center document rooms)

## FDA ESTRI GatewayCapability

**Key Functionality**
**Logging and Tracking Issues at the Gateway**
- Official receipt date/time
- Acknowledgment that comes back from the Gateway is simply an acknowledgment that Templar was able to correctly process it.  It is not the Center level acknowledgment.
- AERS system will send back an application level acknowledgment when the submission correctly loads into the database

## Center Retrieves &

- 1.  Encrypted Message
- Arrives

- 2.  Templar Attempts
- to Decrypt/Authenticate

- 3.  Templar Validates
- EDIFACT Information

- 4a.  Invalid - Stop

- 4b.  Valid -
- Send Acknowledgment

- Tracking Log

- 4d - Place on Center’s
- Directory

- 4c - Record Action
- in Tracking Log

**Center Retrieves &**
**Processes & ‘Acknowledges’**

## FDA ESTRI Gateway Gateway ComponentsConceptual Overview

## FDA ESTRI GatewayTrading Partner Information Package

***The Agreement Will Specify:***
- Required information for electronic exchange
- Business Information
- Technical Specifications
- ‘Certification’ Process

**The Agreement Will Not Imply Regulatory Compliance.  It Simply Outlines ‘Rules of Usage’ of the Gateway. **

## Key Rules of Usage

Organizations follow a Certification Process
Organizations are only Certified once for trading with the Agency
After Certification, FDA Centers decide schedule / content for electronic submissions

- Organizations follow a Certification Process
- Organizations are only Certified once for trading with the Agency
- After Certification, FDA Centers decide schedule / content for electronic submissions

- FDA ESTRI Gateway_Trading Partner Information__ Package_

## FDA ESTRI Gateway  How to get started 

- The steps to begin to send AERS electronic submissions through the Gateway would be the following:
- Join the CDER AERS E-Subs pilot program
- Extract the data into E2B/M2 format
- Ability to generate the EDIFACT UNB header and UNZ trailer "envelope" around the E2B/M2 data
- Compatibility with Templar Enterprise 4.0 for UNIX
- Read www.fda.gov/oc/electronicsubmissions/interfaq.htm
- Complete the Trading Partner Information Package (TPIP) with the FDA.  To obtain a copy of the TPIP, e-mail your request to edigateway@oc.fda.gov

## FDA ESTRI Gateway  How to get started

_*  *__*Required Message Structure*_

## FDA ESTRI GatewayCapability

**Conceptual Overview**
**Implications of Using Templar**
- Templar does not generate the EDIFACT Header or Trailer
- Requires Administration and Key Mgmt.
- Scalable Solutions
- Still Need Other Software Components
- Recommended by ICH

## FDA ESTRI GatewayProducts Compatible with Templar 4.0

- Internet

**Encryption**

**Digital Signature**

**Signed Receipts**

- FDA ESTRI Gateway_Products Compatible with Templar 4.0_

- Interchange v2.0

- Templar v4.0
- Guardian v2.0

- SAMM v1.0
- (Communications
-     Module for
-     COMMERCE:
-     Exchange)

- EXCpert

- REIMS® Secure
- ECI Module v2.0

## FDA ESTRI Gateway Industry Partners

- Testing in-progress
- Pharmacia
- Roche
- Glaxo SmithKline
- Testing soon
- Bristol-Myers Squibb
- Merck

## FDA ESTRI Gateway  Lessons Learned

- Evaluate your mail system
- Become familiar with syntax of:
- EDIFACT header and trailer format
- SGML format
- Setup an internal gateway-to-gateway and test internally

## For More Information on the FDA ESTRI Gateway contact:

- Elizabeth Chew
- FDA / Office of Information Resources Mgmt
- 5600 Fishers Lane
- Mail Stop HF-21
- Rockville, MD 20857
- 301-827-0964
- www.fda.gov/oc/electronicsubmissions/interfaq.htm
- edigateway@oc.fda.gov