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Functional Areas
- Audit and Investigations
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Capacity development and transition, strengthening systems for health
- A Strategic Approach to Capacity Development
- Capacity Development and Transition - Lessons Learned
- Capacity development and Transition Planning Process
- Capacity Development and Transition
- Capacity Development Objectives and Transition Milestones
- Capacity Development Results - Evidence From Country Experiences
- Functional Capacities
- Interim Principal Recipient of Global Fund Grants
- Legal and Policy Enabling Environment
- Overview
- Resilience and Sustainability
- Transition
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Financial Management
- CCM Funding
- Grant Closure
- Grant Implementation
- Grant-Making and Signing
- Grant Reporting
- Import duties and VAT / sales tax
- Overview
- Sub-recipient Management
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Grant closure
- Overview
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Steps of Grant Closure Process
- 1. Global Fund Notification Letter 'Guidance on Grant Closure'
- 2. Preparation and Submission of Grant Close-Out Plan and Budget
- 3. Global Fund Approval of Grant Close-Out Plan
- 4. Implementation of Close-Out Plan and Completion of Final Global Fund Requirements (Grant Closure Period)
- 5. Operational Closure of Project
- 6. Financial Closure of Project
- 7. Documentation of Grant Closure with Global Fund Grant Closure Letter
- Terminology and Scenarios for Grant Closure Process
- Human resources
- Human rights, key populations and gender
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Legal Framework
- Agreements with Sub-recipients
- Agreements with Sub-sub-recipients
- Amending Legal Agreements
- Implementation Letters and Performance Letters
- Language of the Grant Agreement and other Legal Instruments
- Legal Framework for Other UNDP Support Roles
- Other Legal and Implementation Considerations
- Overview
- Project Document
- Signing Legal Agreements and Requests for Disbursement
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The Grant Agreement
- Grant Confirmation: Conditions Precedent (CP)
- Grant Confirmation: Conditions
- Grant Confirmation: Face Sheet
- Grant Confirmation: Schedule 1, Integrated Grant Description
- Grant Confirmation: Schedule 1, Performance Framework
- Grant Confirmation: Schedule 1, Summary Budget
- Grant Confirmation: Special Conditions (SCs)
- Grant Confirmation
- UNDP-Global Fund Grant Regulations
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Monitoring and Evaluation
- Differentiation Approach
- Monitoring and Evaluation Components of Funding Request
- M&E Components of Grant Implementation
- Monitoring and Evaluation Components of Grant Making
- Overview
- Principal Recipient Start-Up
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Health Product Management
- Compliance with the Global Fund requirements
- Distribution
- Inspection and Receipt
- International freight, transit requirements and use of INCOTERMS
- Inventory Management
- Overview - Health Product Management
- Pharmacovigilance
- Product Selection
- Quality monitoring of health products
- Quantification and Forecasting
- Rational use
- Risk Management for PSM of health products
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Sourcing and regulatory aspects
- Development of List of Health Products
- Development of the Health Procurement Action Plan (HPAP)
- Global Health Procurement Center (GHPC)
- Guidance on donations of health products
- Health Procurement Architecture
- Local Procurement of health products
- Other Elements of the UNDP Procurement Architecture
- Procurement of non-pharmaceutical Health Products
- Procurement of Pharmaceutical Products
- Submission of GHPC CO Procurement Request Form
- Storage
- Supply Planning of Health Products
- UNDP Health PSM Roster
- Waste management
- Grant Reporting
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Risk Management
- Introduction to Risk Management
- Overview
- Risk management in crisis settings
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Risk Management in the Global Fund
- Additional Safeguard Policy
- Challenging Operating Environment (COE) Policy
- Global Fund Review of Risk Management During Grant Implementation
- Global Fund Risk Management Framework
- Global Fund Risk Management Requirements During Funding Request
- Global Fund Risk Management Requirements for PRs
- Local Fund Agent
- Risk management in UNDP
- Risk Management in UNDP-managed Global Fund projects
- UNDP Risk Management Process
- Sub-Recipient Management
Diagnostics for Research Use Only (RUO)
Research use only (RUO) products are products intended for research procedures and not intended for the diagnostic or treatment management of patients. RUO reagents and equipment are not subject to IVD or “medical devices” regulatory requirements and, thus, are not subject to evaluation for accuracy, specificity, precision, and reproducibility, and any evidence provided with RUO products is not certified by a regulatory or independent authority. Therefore, these items should only be used by experienced scientists, biologists and/or microbiologists in an authorized laboratory following strict procedures.
RUO reagents and instruments can only be procured and used for research use, including genomic sequencing purposes, and epidemiology purposes, and may not be used for in vitro diagnostic procedures.
Practice Pointerit is possible that products, which seem identical, are available but that one is intended for clinical diagnosis while the other is intended for RUO. For example – “Applied Biosystems, QuantStudio 5 real-time PCR systems - A28570 (RUO)” vs “Applied Biosystems, QuantStudio 5 Dx Real-Time PCR System - A47326 (Clinical Diagnostics)”.
Under exceptional circumstances, these reagents and instruments can be procured for diagnostic procedures (e.g., when no commercial IVD device exists or when an existing IVD does not meet patient-specific clinical needs); however, this requires documented validated procedures which are implemented by authorized qualified personnel in an authorized laboratory.
UNDP COs must ensure that they obtain the correct product specifications which are aligned with the “intended use/purpose” for the items which need to be procured and, where items are classified as “RUO” that they get written confirmation from the Government that 1) the RUO products being requested will be used for the intended purpose (i.e., for research use only), or 2) the RUO products being requested will be used for diagnostic purposes. If the latter, the Government must clearly define and articulate the conditions under which the RUO products will be used for diagnostic purposes. In both cases, the information must be shared with the UNDP QA Team; the UNDP QA Team will acknowledge the communication and will stipulate that the end-user is fully responsible for any off-label use of these RUO products.
Where the RUO equipment(s) and/or reagents(s) are financed by the Global Fund, the Principal Recipient must confirm to the UNDP QA Team that the RUO equipment(s) and/or reagent(s) have been approved for the stated intended purpose by the Global Fund, and that it is included in the approved grant Health Product Management Template (HPMT).
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