Notice of Changes to RFA-AI-19-002 "HIV/AIDS Clinical Trials Networks Statistical and Data Management Centers (UM1 Clinical Trial Required)"

Notice Number: NOT-AI-19-051

Key Dates
Release Date: March 11, 2019

Related Announcements
RFA-AI-19-002

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Notice is to inform applicants of two changes to RFA-AI-19-002 "HIV/AIDS Clinical Trials Networks Statistical and Data Management Centers (UM1 Clinical Trial Required)". This Notice removes specific text from Part 2. Section I and from Part 2. Section IV.

Part 2: Full Text of Announcement

Section I. Funding Opportunity Description

Statistical and Data Management Center Specific Responsibilities

Data Collection and Management

The Funding Opportunity Announcement (FOA) currently reads:

The SDMC provides, maintains, supports and updates commercial off-the-shelf (COTS) clinical trial management systems that include electronic data capture (EDC) and are interoperable with the laboratory information management systems (LIMS). These systems provide data collection, exchange, storage, tracking and retrieval of clinical and laboratory data for the network including CTUs/CRSs and Protocol-Specific sites.

Both clinical trial management systems and laboratory information management systems must be 21CFR part 11 and ICH E6 compliant. DAIDS reserves the right to audit the vendors and their sub-contractors.

As needed, the SDMC interfaces, integrates or adapts its information system(s) to be interoperable with NIAID systems.

The SDMC supports collecting, storing and providing data in accordance with regulatory requirements as defined by FDA and ICH and collaborating with other DAIDS-affiliated SDMCs in the development of data elements that do not currently exist within CDISC.

The SDMC provides specific capabilities including:

  • an Interactive Response Technology (IRT) System for subject registration and randomization
  • a laboratory information management system that integrates with IRT to manage study specimens in real time, for use by the SDMC, study sites, laboratories and others.
  • an electronic data capture clinical data (EDC) system(s) and associated electronic case report forms (ECRFs) that are compliant with 21 Code of Federal Regulations (CFR) Part 11 and Health Insurance Portability and Accountability Act (HIPAA) for remote/direct data entry and transmission of subject data from study sites and laboratories to the central data management location. The EDC system must be interoperable or fully integrated so that data from various sources can be merged to yield generalizable results. The system provides for targeted source data verification.

The SDMC may establish procedures for alternative data capture (e.g., a system for off-line data entry when internet connection is not available) as described in NIAID DAIDS policies.

When Electronic Health Record (EHR) Systems are used the SDMC will ensure the interoperability of the EHR data and the EDC system and maintain a record of EHR systems used by each clinical research site and status of data sharing agreements.

The SDMC provides timely data access, statistical analysis and reports for:

  • Safety Oversight, and the Safety Oversight committees.
  • Clinical research site and protocol-specific reports: Provide reports such as accrual, demographics, protocol deviations, data queries, timeliness of data submission, and response to queries for quality assurance purposes and for protocol project management.
  • Clinical research source data collected in studies sponsored/funded by NIAID/DAIDS and its IC partners for purposes of clinical monitoring.

The Funding Opportunity Announcement (FOA) modified to read without italicized language above:

The SDMC provides, maintains, supports and updates commercial off-the-shelf (COTS) clinical trial management systems that include electronic data capture (EDC) and are interoperable with the laboratory information management systems (LIMS). These systems provide data collection, exchange, storage, tracking and retrieval of clinical and laboratory data for the network including CTUs/CRSs and Protocol-Specific sites.

Both clinical trial management systems and laboratory information management systems must be 21CFR part 11 and ICH E6 compliant. DAIDS reserves the right to audit the vendors and their sub-contractors.

As needed, the SDMC interfaces, integrates or adapts its information system(s) to be interoperable with NIAID systems.

The SDMC supports collecting, storing and providing data in accordance with regulatory requirements as defined by FDA and ICH and collaborating with other DAIDS-affiliated SDMCs in the development of data elements that do not currently exist within CDISC.

The SDMC provides specific capabilities including:

  • an Interactive Response Technology (IRT) System for subject registration and randomization
  • a laboratory information management system that integrates with IRT to manage study specimens in real time, for use by the SDMC, study sites, laboratories and others.
  • an electronic data capture clinical data (EDC) system(s) and associated electronic case report forms (ECRFs) that are compliant with 21 Code of Federal Regulations (CFR) Part 11 and Health Insurance Portability and Accountability Act (HIPAA) for remote/direct data entry and transmission of subject data from study sites and laboratories to the central data management location. The EDC system must be interoperable or fully integrated so that data from various sources can be merged to yield generalizable results. The system provides for targeted source data verification.

The SDMC may establish procedures for alternative data capture (e.g., a system for off-line data entry when internet connection is not available) as described in NIAID DAIDS policies.

The SDMC provides timely data access, statistical analysis and reports for:

  • Safety Oversight, and the Safety Oversight committees.
  • Clinical research site and protocol-specific reports: Provide reports such as accrual, demographics, protocol deviations, data queries, timeliness of data submission, and response to queries for quality assurance purposes and for protocol project management.
  • Clinical research source data collected in studies sponsored/funded by NIAID/DAIDS and its IC partners for purposes of clinical monitoring.

Section IV. Application and Submission Information

2. Content and Form of Application Submission

Sub-section B. Data Collection and Management

The Funding Opportunity Announcement (FOA) currently reads:

  • Describe your clinical trial management systems and how they will provide data collection, exchange, storage, tracking and retrieval of clinical and laboratory data for the network research agenda being supported including CTUs/CRSs and Protocol-Specific sites. Describe the nature and type of data to be collected, and how these data taken together will address the overall goals and objectives for network clinical studies for the network that will be supported.
  • Describe your policies and procedures for interfacing, integrating and or adapting information system(s) to interact with clinical research management systems such as NIAID N-CRMS or other information systems or components specified by NIAID.
  • Describe your capabilities for:
  • an Interactive Response Technology (IRT) System for subject registration and randomization
  • a laboratory information management system that integrates with IRT to manage study specimens in real time, for use by the SDMC, study sites, laboratories and others.
  • an interoperable or fully integrated electronic data capture clinical data (EDC) system(s) and associated electronic case report forms (ECRFs) that are compliant with Title 21 Code of Federal Regulations (CFR) Part 11 and Health Insurance Portability and Accountability Act (HIPAA) for remote/direct data entry and transmission of subject data from study sites and laboratories to the central data management location.
  • targeted source data verification.
  • Describe procedures for alternative data capture (e.g., a system for off-line data entry when internet connection is not available) as described in NIAID DAIDS policies
  • Describe the process and timelines for reports, data access and statistical analysis for
    • Safety Oversight, and the Safety Oversight committees.
    • Clinical research site and protocol -specific reports such as accrual, demographics, protocol deviations, data queries, timeliness of data submission, and response to queries for quality assurance purposes and for protocol project management.
    • Clinical research source data collected in studies sponsored/funded by NIAID/DAIDS for purposes of clinical monitoring.
    • Determining co-enrollment for protocol status reports.
  • Describe your procedures for interoperability of the EHR data and the EDC system when Electronic Health Record (EHR) Systems are used. Describe the documentation you maintain for a record of EHR systems used by each clinical research site.
  • Describe procedures for compliance with NIAID DAIDS policies, regulations and procedures. Describe procedures used to guide software development including project planning, requirements definition, system design, implementation, integration and testing, deployment, maintenance, and system retirement. Describe validation processes.
  • Describe efforts to establish processes and methods for common IT architecture in the clinical research community including defining technical standards, identifying security requirements, and identifying and integrating existing resources, promoting the use of clinical and research data that are machine readable and that adhere to the FAIR (findable, accessible, interoperable, and re-useable) principles.
  • Describe the implementation and use of validated data collection systems, forms and formats, and identify any innovations in adapting database systems and structures to accommodate various clinical site, laboratory and collaborator needs.
  • Address compliance with 21 CFR 11, HIPAA, and ability to support data interchange standards. Describe alignment with workflow systems.
  • Describe the system for subject randomization and procedures for strict maintenance of blinding throughout studies. Describe procedures used for study randomization, randomization systems supported (web-based allocation, touch tone allocation, permuted block allocation, etc.), and procedures for verification and validation of eligibility prior to randomization. Describe the integration of your randomization system with the workflow and ability to generate protocol status reports.
  • Describe the system and capabilities of the validated laboratory information management system to track specimens.
  • Describe how the SDMC will support Good Data Practices. Describe efforts to develop and implement standard uniform protocols for data collection (e.g., Common Data Elements [CDE]).
  • Outline the process and timeline for the SDMC to prepare for the implementation of an individual study including electronic Case Report Form (eCRFs), protocol-specific and site-specific randomization and data entry screens, and other study-related materials as needed.
  • Describe plans to shift current data collection and management practices to address changes in regulatory requirements or opportunities provided by information technology advances and any advantage they may have over existing methodologies.
  • Describe your project management system for forecasting the timelines for protocols and the need to provide data management, collection, and retrieval of data. Include the process for ongoing tracking of planned versus actual milestones. Describe the plans for communications to and from the LOC and means for adjusting resources as needed to meet agreed upon protocol schedules.

The Funding Opportunity Announcement (FOA) modified to read without italicized language above:

  • Describe your clinical trial management systems and how they will provide data collection, exchange, storage, tracking and retrieval of clinical and laboratory data for the network research agenda being supported including CTUs/CRSs and Protocol-Specific sites. Describe the nature and type of data to be collected, and how these data taken together will address the overall goals and objectives for network clinical studies for the network that will be supported.
  • Describe your policies and procedures for interfacing, integrating and or adapting information system(s) to interact with clinical research management systems such as NIAID N-CRMS or other information systems or components specified by NIAID.
  • Describe your capabilities for:
  • an Interactive Response Technology (IRT) System for subject registration and randomization
  • a laboratory information management system that integrates with IRT to manage study specimens in real time, for use by the SDMC, study sites, laboratories and others.
  • an interoperable or fully integrated electronic data capture clinical data (EDC) system(s) and associated electronic case report forms (ECRFs) that are compliant with Title 21 Code of Federal Regulations (CFR) Part 11 and Health Insurance Portability and Accountability Act (HIPAA) for remote/direct data entry and transmission of subject data from study sites and laboratories to the central data management location.
  • targeted source data verification.
  • Describe procedures for alternative data capture (e.g., a system for off-line data entry when internet connection is not available) as described in NIAID DAIDS policies
  • Describe the process and timelines for reports, data access and statistical analysis for
    • Safety Oversight, and the Safety Oversight committees.
    • Clinical research site and protocol -specific reports such as accrual, demographics, protocol deviations, data queries, timeliness of data submission, and response to queries for quality assurance purposes and for protocol project management.
    • Clinical research source data collected in studies sponsored/funded by NIAID/DAIDS for purposes of clinical monitoring.
    • Determining co-enrollment for protocol status reports.
  • Describe procedures for compliance with NIAID DAIDS policies, regulations and procedures. Describe procedures used to guide software development including project planning, requirements definition, system design, implementation, integration and testing, deployment, maintenance, and system retirement. Describe validation processes.
  • Describe efforts to establish processes and methods for common IT architecture in the clinical research community including defining technical standards, identifying security requirements, and identifying and integrating existing resources, promoting the use of clinical and research data that are machine readable and that adhere to the FAIR (findable, accessible, interoperable, and re-useable) principles.
  • Describe the implementation and use of validated data collection systems, forms and formats, and identify any innovations in adapting database systems and structures to accommodate various clinical site, laboratory and collaborator needs.
  • Address compliance with 21 CFR 11, HIPAA, and ability to support data interchange standards. Describe alignment with workflow systems.
  • Describe the system for subject randomization and procedures for strict maintenance of blinding throughout studies. Describe procedures used for study randomization, randomization systems supported (web-based allocation, touch tone allocation, permuted block allocation, etc.), and procedures for verification and validation of eligibility prior to randomization. Describe the integration of your randomization system with the workflow and ability to generate protocol status reports.
  • Describe the system and capabilities of the validated laboratory information management system to track specimens.
  • Describe how the SDMC will support Good Data Practices. Describe efforts to develop and implement standard uniform protocols for data collection (e.g., Common Data Elements [CDE]).
  • Outline the process and timeline for the SDMC to prepare for the implementation of an individual study including electronic Case Report Form (eCRFs), protocol-specific and site-specific randomization and data entry screens, and other study-related materials as needed.
  • Describe plans to shift current data collection and management practices to address changes in regulatory requirements or opportunities provided by information technology advances and any advantage they may have over existing methodologies.

Describe your project management system for forecasting the timelines for protocols and the need to provide data management, collection, and retrieval of data. Include the process for ongoing tracking of planned versus actual milestones. Describe the plans for communications to and from the LOC and means for adjusting resources as needed to meet agreed upon protocol schedules.

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Phillip Renzullo, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3041
Email:prenzullo@niaid.nih.gov