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May 2008 DAIDS Council-Approved Concepts

Concepts represent early planning stages for program announcements, request for applications, or solicitations for Council 's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to the Opportunities and Announcements portal.

NB: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

  • DAIDS Clinical Site and Study Monitoring Contract
  • Clinical Research Auditing
  • Regulatory Support Center
  • HIV Clinical Research Support
  • Basic Vaccine Discovery

DAIDS Clinical Site and Study Monitoring Contract

Request for Proposals

Contact: Anita Hughes
Phone: 301-451-3694
Internet: AnHughes@niaid.nih.gov

Objective: The objective of this contract is to provide on-site monitoring of DAIDS-sponsored clinical trial studies and clinical trial sites.

Description: This contract initiative will provide monitoring for international and domestic clinical trials sponsored by DAIDS. The Clinical Site Monitoring Contractor(s) will be responsible for the following activities:

  • On-site GCP/ICH monitoring, including monitoring of pharmacies
  • Generate monitoring plans for studies
  • Prepare for, conduct, and report results of visits in both written and verbal reports
  • Provide trained monitors
  • Project Management of the contract (fiscal, operational, resource, administrative)
  • Conduct special assignments
  • Conduct conference calls and provide minutes for planning and reporting of monitoring activities
  • Potential development and/or maintenance of existing databases for reporting and tracking monitoring reports
  • Interface with the DAIDS Enterprise System (ES) as necessary
  • Provide QA/QC functions for monitoring activities

Periodic on-site monitoring visits will be conducted at sites to examine source documents and other related clinical trials documents to assess the accuracy and completeness of the trial data, to identify problems with protocol implementation, Good Clinical Practices/ICH adherence, and all applicable regulatory requirements. Monitors will review IRB documentation, informed consents, and site registration of protocols. Additionally, monitors will verify the proper storage, dispensation, and accountability of investigational study products. They may be asked to complete special assignments should a site display performance problems.

Clinical Research Auditing

For the published initiative, see the December 11, 2008, solicitation, NIAID/DAIDS Clinical Research Auditing.

Request for Proposals

Contact: Jason Bell
Phone: 301-496-0612
Internet: belljas@niaid.nih.gov

Objective: The objective of this contract will be to provide DAIDS with independent and specialized quality assurance auditing of the monitoring of DAIDS clinical research and third party “for cause” auditing of clinical research sites.

Description: This initiative will provide independent auditing in support of international and domestic clinical research sponsored by DAIDS. The Clinical Research Auditing contractor will be responsible for the following activities:

  • Independent quality assurance auditing of the performance of the DAIDS clinical site monitor contractor, including associated pharmacy and laboratory monitoring.
  • Independent quality assurance auditing of non-DAIDS-contracted clinical site monitors, at the direction of the Project Officer.
  • Special assignments, including third party “for cause” on-site audits of clinical research sites and, as applicable, associated pharmacies and laboratories.
  • Generation of detailed audit plans for assigned auditing tasks.
  • Preparing for, conducting, and reporting results of audits conducted in both written and verbal reports.
  • Provision of trained auditors and standard operating procedures (SOPs), guidelines, and tools/templates for the auditing process.
  • Project Management of the contract (fiscal, operational, resource, and administrative).
  • Conducting meetings to plan auditing activities and to report audit findings, and provide minutes of the meetings.
  • Potential development and/or maintenance of existing databases for tracking and archiving auditing reports.
  • Interfacing with the DAIDS-Enterprise System (ES) contractor as necessary.

Periodic auditing visits will be conducted at clinical research sites to measure the consistency, thoroughness, and quality of on-site monitoring by DAIDS monitors and non-DAIDS monitors. It is anticipated that the contractor will audit a minimum of 10 percent of scheduled monitoring visits during the first year of the contract. Based upon audit findings, this number may be adjusted. Auditors may be asked to complete special assignments (primarily third party “for cause” on-site audits) to address serious performance problems at clinical research sites.

Regulatory Support Center

For the published initiative, see the May 11, 2009, solicitation.

Request for Proposals

Contact: Joshua LaVine
Phone: 301-496-0612
Internet: jlavine@niaid.nih.gov

Objective: To provide: (1) the required regulatory expertise and support necessary to perform DAIDS-funded and/or -sponsored domestic and international clinical trial research, (2) training in key functions of clinical trial research investigators, and (3) computer and database expertise required for entering and maintaining all contract-associated data and records in the DAIDS Enterprise System.

Description:

  • Investigational new drug (IND) and non-IND support and related regulatory services.
  • Human subjects protection – informed consents and their translations and planning and conduct of training in human subjects protection issues.
  • On-site review of consent forms, IRB approvals, FDA forms, document filing and tracking, and training on protocol review.
  • Meeting support, meeting logistics, and preparation and distribution of review letters.
  • Safety reporting management – IND safety reports and non-IND Med WATCH reports.
  • Staff and operate a Safety Information Center and distribute safety information to investigators, operations centers, drug companies, etc.
  • Track and support clinical trial negotiations and documents.
  • Computer database maintenance, updating, and user support for day to day operations.
  • Web site support, security, system modifications/upgrades, and effective interface with data centers and the DAIDS Enterprise System (ES).
  • Responses to special requests from government and non-government entities.

Expanded scope and/or budget areas include:

  • Performance of pharmacovigilance-related safety data queries of appropriate databases.
  • Conduct of two-way reconciliation between Expedited Adverse Event/Serious Adverse Event databases and DAIDS data management centers.
  • Implementation of standardized Medical Dictionary for Regulatory Activities (MedDRA) coding processes.
  • IT support and maintenance/updates to interface with data management centers and the current and evolving ES regulatory-related modules.
  • Establish and maintain a protocol information office to receive, abstract, enter, distribute, and track protocol document-related information sent to DAIDS.

HIV Clinical Research Support

Request for Proposals

Contact: Cassandra Ellis
Phone: 301-451-3691
Internet: ellisca@niaid.nih.gov

Objective: This contract will provide wide ranging clinical trial research management services on a standard basis as well as in response to periodic, auxiliary, or special needs that arise in maintaining current operations or responding quickly to situations requiring resources above those planned for and established.

Description: To date no changes have been made in the scope, mechanism, or budget for this initiative. This contract will continue to provide clinical trial management and support resources to DAIDS-funded studies as needed, and that include activities in four broad areas:

  • Research Program Management (subcontracting resources, information technology, meetings)
  • Clinical/Laboratory Site Support (site support, specialized labs, procedure harmonization)
  • Clinical Trial Support (DSMB coordination, data and biostatistical support, regulatory consultation)
  • GCP/GCLP and Regulatory Compliance (quality management, training)

     

Basic Vaccine Discovery

For the published initiative, see the May 19, 2009, Guide announcement, Basic HIV Vaccine Discovery Research.

Request for Applications

Contact: Stuart Shapiro
Phone: 301-402-0122
Internet: sshapiro@niaid.nih.gov

Objective: The goal of this initiative is to accelerate HIV vaccine discovery efforts by supporting the generation of new knowledge that will inform new conceptual approaches to HIV vaccine design and/or yield new HIV vaccine designs.

Description: This program is designed to support a broad range of research that can lead to highly significant HIV vaccine-applicable discoveries. Knowledge gained from these projects should lead to new approaches for vaccine design. Research that outlines new approaches to overcoming difficult scientific obstacles and that may come from diverse fields, including but not limited to virology, immunology, genetics, cellular biology, and structural biology, is highly encouraged. Examples of fundable research ideas may originate from feedback obtained from the Request for Information (RFI) NOT-AI-08-048, as well as the recently held NIAID HIV vaccine summit. This program is expected to support studies that may include:

  • Structural biology of HIV envelope trimer and novel designs to induce broadly reactive antibodies.
  • Correlates of vaccine-induced immune protection.
  • Role of innate/mucosal immunity in control of SIV infection and vaccine-induced protection.
  • Understanding of earliest events in SIV infection; how HIV gets to the GALT and how cells are mobilized to site(s) of infection.
  • Why broadly neutralizing antibodies are rare and what is required to enable a vaccine to induce such antibodies.
  • Mechanisms of control of SIV, especially elite controllers, and the features of a vaccine required to mimic that control.
  • Mechanisms of apathogenesis of SIV in some non-human primate species and how that could be mimicked in a vaccine.
  • Role of cell activation in disease and the implications for vaccine design.

     

Last Updated July 08, 2011

Last Reviewed August 03, 2009