DELIVERY ORDER
MT&H SYSTEMS, LLC - IGF::OT::IGF SAFTEY REPORTING PORTAL (SRP) ENHANCEMENT - MODIFY THE EXISTING SRP SYSTEM TO MEET THE BUSINESS NEEDS OF CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER) BY LEVERAGING THE SRP SYSTEM TO IMPLEMENT A NEW RATIONAL QUESTIONNAIRE (RQ). THE RQ WILL PROVIDE A MEANS TO ALLOW THE REPORTING OF MANDATORY CBER BLOOD ADVERSE EVENT (AE) REPORTING IN A UNIFIED AND CONSISTING MANNER FOR BLOOD DONATION REPORTS AND BLOOD TRANSFUSION REPORTS. THE RQ IS TO CONSIST OF ABOUT 100 DATA ELEMENTS (QUESTIONS) COVERING BOTH REPORT TYPES BLOOD DONATION REPORTS AND BLOOD TRANSFUSION REPORTS. THE RQ DATA ELEMENTS MUST BE MAPPED TO THE E2BR2 SCHEMA.
PIID: 75F40118F01007
Effective Date: Sep 7, 2018End Date: Closed on Mar 31, 2020
Key Details
Description
IGF::OT::IGF SAFTEY REPORTING PORTAL (SRP) ENHANCEMENT - MODIFY THE EXISTING SRP SYSTEM TO MEET THE BUSINESS NEEDS OF CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER) BY LEVERAGING THE SRP SYSTEM TO IMPLEMENT A NEW RATIONAL QUESTIONNAIRE (RQ). THE RQ WILL PROVIDE A MEANS TO ALLOW THE REPORTING OF MANDATORY CBER BLOOD ADVERSE EVENT (AE) REPORTING IN A UNIFIED AND CONSISTING MANNER FOR BLOOD DONATION REPORTS AND BLOOD TRANSFUSION REPORTS. THE RQ IS TO CONSIST OF ABOUT 100 DATA ELEMENTS (QUESTIONS) COVERING BOTH REPORT TYPES BLOOD DONATION REPORTS AND BLOOD TRANSFUSION REPORTS. THE RQ DATA ELEMENTS MUST BE MAPPED TO THE E2BR2 SCHEMA.
Contractor Information
Contractor: MT&H SYSTEMS, LLC
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