Project Management Standard Operating Procedure

Project Management Standard Operating Procedure
1. FIND QUALITY MANAGEMENT SYSTEM
FIND is certified for “Project Management for Design, Development and Manufacturing of IVDs,
Evaluation, Demonstration and Collecting Evidence for Scale-up, and Scale-up of IVDs” in compliance
with international standards 13485:2003 (Medical Devices-Quality Management Systems-
Requirements for Regulatory Purposes) and 9001:2008 (Quality Management Systems-
Requirements); this certification extends to both of the FIND satellite offices in India and Uganda.
FIND Quality Management System (QMS) is designed to ensure that ISO standards are implemented
throughout all organizational processes and procedures. The Quality Manual is the principle quality
procedure while the FIND project management strategy is described in a dedicated Standard
Operating Procedure entitled “Project Management SOP QP 05-00-01” (PM SOP). Compliance of all
project-related processes with the PM SOP is a prerequisite for continuing FIND ISO certification.
FIND is dedicated to a process of continuous improvement and review of its Quality Management
Systems and the objectives embodied in them. FIND senior management defines annual quality
objectives and evaluates performance of the organization according to targets attained. Achievement
of planned project milestones within the projected timelines is one of the most important performance
indicators of high quality project management and is assessed on a regular basis.
2. FIND PROJECTS
FIND aims to provide its customers with innovative and affordable in-vitro diagnostic (IVD) products for
all levels of the health care system while maintaining its strong commitment to quality systems. FIND
does not own manufacturing facilities, design or development laboratories, clinical trial sites, reference
laboratories or laboratories for quality control, and has no capabilities for storage of biological
reference material, or marketing and sales. All activities necessary for design, development,
manufacture, evaluation and demonstration, collecting evidence for scale-up and scale-up of IVDs, are
performed through cooperation with various partners. FIND’s primary role is therefore the
management of projects with subcontracted partners.
The FIND project portfolio covers three major disease areas: tuberculosis (including HIV), human
African trypanosomiasis (including visceral leishmaniasis), and malaria. All projects are structured into
phases and milestones. Milestones require the detailed, documented attainment of pre-defined
targets. Most projects entail the development and/or validation and distribution of in-vitro diagnostic
products to FIND target markets and are called “typical projects”. Typical projects begin with the
Concept phase and progress through Feasibility, Development, Evaluation, Demonstration, Collecting
Evidence for Scale-up and Scale-up and Impact, a total of seven phases and seven milestones.
Projects to facilitate IVD performance evaluation or adoption in FIND target markets are called “nontypical
projects”; these do not follow the same phases as typical projects or result in a diagnostic
product that can be distributed to FIND target markets. Examples of non-typical projects are:
• Development of a central specimen bank
• Implementation of laboratory training programmes at potential trial sites
• Projects to facilitate laboratory preparedness and uptake of new diagnostics at selected sites in
FIND target markets
• Preparation of business plans or market reports

Project Flow: Phases and Milestones
Fig.1: Project flow of “typical” FIND projects
Concept Definition
A project milestone details the completed achievements of a phase; these must be reviewed by senior
management and presented at project management meetings, as described in the FIND milestone
review process. Planning documents of the next project phase must be prepared and approved prior
to the start of the next project phase activities.
Table 1: Project phases and milestones of typical projects
Project phase Milestone after completion of project phase
A
Feasibility
B
Development
D
Evaluation
E
Demonstration
F
Collecting Evidence
for Scale-up
G
Scale-up & Impact
H
Phase
Milestone
Concept Definition MS 1 (Concept defined)
Feasibility MS 2 (Feasibility completed)
Development MS 3 (Development completed)
Evaluation MS 4 (Evaluation completed)
Demonstration MS 5 (Demonstration completed)
Collecting Evidence for Scale-up MS 6 (Introduction in ≥2 countries)
Scale-up & Impact MS 7 (Implementation in >5-10 countries; Impact monitored and
evaluated)
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3. PROJECT MANAGEMENT
Project leaders are responsible for steering their project/s through each phase and receive support
from functional units such as project management, finance, contract management, human resources,
and the Chief Scientific and Senior Technology Officers. Project leaders must finalize all necessary
documents for archiving in the project history file (PHF), including: records of conferences or
meetings, trip reports, publications, milestone-related document deliverables, agreements, study
protocols, and as documents that trace actions, decisions and results for each project. The PHF is
managed and monitored by the Office of Project Management (OPM) and is kept up-to-date by
designated staff members. The following tasks are the responsibility of the project leader:
• Initiating projects
• Carrying projects successfully to last project milestone
• Proposing partners, cooperating with partners and tracking achievements
• Managing and tracking timelines and project expenses against an approved budget
• Guiding all project-related activities, including contracts and clinical trials
• Preparing all milestone-related documents and applying for milestone approval
• Preparing trip reports and meeting minutes
• Providing Document Controller with project-related documents for PHF and ensuring
completeness of PHF dossier for his/her project at any time
• Ordering and shipping (i) kits / reagents / devices for trial sites (ii) reference materials (from
collection sites to repository, trial sites and cooperation partners)
The Office of Project Management (OPM) organizes and chairs regular project management meetings
(PMM) – attended by senior management and project staff – that allow for project monitoring and
assessment, as well as broader programme planning and navigation. The OPM additionally organizes
shipment of all clinical trial material to trial sites in developing countries in compliance with national
and local regulations.
4. QUALITY ASSESSMENT OF COOPERATION PARTNERS
FIND, together with its cooperation partners, is committed to meeting the needs of its customers in
low-income economies by designing, developing, manufacturing IVDs for infectious diseases, and
then evaluating and demonstrating their performance and efficiency, and by working to ensure product
access at all levels of the public health care system, and showing the impact of the diagnostics on
health care. Partners are selected by FIND senior management and are commissioned, under
contract, to take over specific activities for some, all or parts of project phases. Industrial partners are
responsible for development, manufacturing, registration, marketing, distribution, customer support
and market vigilance of IVDs. It is FIND policy to preferentially subcontract manufacturers that comply
with ISO and IVD-GMP standards in design, development and manufacturing of innovative new
diagnostics. This ensures that targets of robust and reproducible field performance according to set
product specifications for FIND target markets, health care level and intended use of new diagnostics,
are met. FIND complies with all national regulations governing its target markets. Sites for
development and evaluation trials must be assessed and certified according to FIND trial site
standards, whereas demonstration trial sites do not need certification, but must represent real field
conditions.
FIND cooperation partners have to undergo due diligence assessments of technical, financial and/or
regulatory status to prove compliance with quality standards and regulatory demands on design and
development, manufacturing, marketing and distribution of IVDs. The following assessments are
performed:
1. Technical due diligence inspection
2. Financial due diligence inspection
3. GMP-IVD due diligence inspection Part A
4. GMP-IVD due diligence inspection Part B
5. Regulatory Control Level Questionnaire of FIND cooperation partner
6. Certification of clinical trial sites
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• Technical due diligence inspection
The purpose of a technical due diligence inspection is to assess the premises, equipment, scientific
and technological expertise of the research cooperation partner for the Feasibility phase. The FIND
inspector may recommend additional improvements that fulfil FIND requirements.
• Financial due diligence inspection
The purpose of a financial due diligence inspection is to assess a partner’s classification of
commercial stage of development, key financials, and associated weaknesses or risks for FIND.
Expert examiners, e.g. members of FIND Financial Office or external experts, should be in charge of
financial inspections.
• GMP-IVD due diligence inspection
The purpose of GMP-IVD due diligence inspections is to assess a partner’s manufacturing capabilities
and their compliance with GMP-IVD practices. These inspections are separated into two parts: Part A
and Part B. Part A inspection is conducted before a manufacturing line of FIND-supported IVD is fully
operational. It entails a general assessment of the partner’s manufacturing facility to verify compliance
with GMP-IVD practices.
Part B inspection assesses the GMP-IVD compliance of the complete manufacturing process of a
FIND-supported IVD and tracks the inclusion of recommendations from Part A inspection (if any). Part
B inspection is conducted when the first lot of FIND-supported IVDs is manufactured at the beginning
of the Evaluation phase (or Demonstration phase, if the Evaluation phase has been bypassed).
• Specimen bank due diligence inspection
The purpose of a specimen bank due diligence inspection is to assess a partner’s capability to serve
as a repository for biological materials, i.e. to act as a specimen bank. The premises, equipment,
scientific and technological expertise of the cooperation partner are evaluated. The inspection is
mandatory prior to signing a contract with the partner to host a bank.
Inspections are conducted by qualified FIND personnel or subcontracted external experts. For due
diligence inspections, an inspection plan must be prepared by the inspector and project leader, and
forwarded to the partner that is to be inspected at least 14 days in advance of the inspection.
5. PRODUCT EVALUATION AND CLINICAL TRIALS
The development of infectious disease diagnostics is critically dependent upon the availability of study
populations in endemic countries during clinical development. Consequently, advancing the
diagnostics in the FIND disease portfolio through the development pathway requires a solid
infrastructure for clinical research. The generation of scientifically sound data and protection of rights
of study participants are basic principles in FIND study design for FIND target markets. Studies are
named according to the product development phase in which they are conducted.
All clinical trials are fully compliant with the laws and ethical standards of the countries in which they
are taking place. Under national legislation, trials will be planned and conducted in collaboration with
the local clinical and laboratory representatives, and trial protocols will be reviewed by an ethical board
(or institutional review board, IRB) that is recognized by the legal authorities. Clinical trials are
performed according to developed FIND standards in compliance with ISO regulations and guidelines
on Good Clinical Practice and Good Laboratory Practice. Shipments of trial materials follow national
importation laws and directives.
Feasibility studies are studies intended to validate proof of principle and provide adequate
preliminary data to warrant initiation of product development. Primary endpoints are analytical and, in
some studies, also operational and clinical test performance. Analytical data, intended to prove that a
given method or set of reagents detects the targeted analyte in concentrations and conditions
adequate for clinical utility in a completed product, may be obtained during validations in laboratories
of research partners. These studies use experimentally prepared research materials, such as dilutions
of bacteria or parasites, purified components or archived clinical reference materials. Early operational
and clinical performance data can, however, already be collected in settings of intended use, at sites
with access to sufficient numbers of specimens from patients being evaluated for the target disease.
Feasibility studies may have abbreviated clinical endpoints and limited discrepant result analysis
compared to Development or Evaluation studies. Sample or patient numbers are normally not
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statistically powered to determine clinical sensitivity and specificity with narrow confidence intervals.
Nevertheless, results must be sufficiently strong to allow FIND to make a correct go no-go decision for
the Development phase and appropriate partner selection. Results of Feasibility studies are judged
against targets detailed in the Feasibility Target Specification document.
Development studies are studies intended to validate IVD prototypes designed and developed by
manufacturing partners before lock of design. Primary endpoints are analytical, operational, and
clinical test performance. Operational and clinical performance data are collected in settings of
intended use, at sites with access to sufficient numbers of specimens from patients being evaluated
with respect to the target disease. Sample or patient numbers are normally not statistically powered to
determine clinical sensitivity and specificity with narrow confidence intervals. Results must be
sufficiently strong to allow manufacturing partner the design-lock of diagnostic product and completion
of Development phase. Results of Development studies are judged against targets detailed in the
Product Specification document.
Evaluation studies are performed on a product that has completed development, and is designlocked
and ready for scaled up manufacture. Such studies are intended to produce high quality data
for use in registration of the product with national regulatory agencies and must be collected in a
manner that conforms to relevant external quality standards. Clinical follow-up of some months might
be required to determine clinical specificity and predictive values of the new test in a population of
suspects of a disease or disease stage. Results of Evaluation studies are judged against targets
detailed in the Product Specification document.
Demonstration studies (“Demonstration projects”) are carried out in the context of a routine clinical
services provision, either directly by the Ministry of Health (MOH), e.g., the National Disease
Programme, or by other agencies working in collaboration with the MOH. Demonstration studies are
large studies, with enrolments of up to 10,000 patients, and are intended to provide the evidence that
new tests that perform well in controlled settings can have an important medical and public health
impact when implemented in programmatic settings. The type of endpoints commonly studied, such as
feasible assay implementation, comparative cost between new and old technologies, and impact on
speed or accuracy of detection and subsequent patient management, require a substantial clinical and
data management infrastructure. A validation phase is required prior to Demonstration studies to
prove capability of trial site laboratories to appropriately implement the IVD under local conditions.
Target of validation phase is usability of IVD and clinical performance evaluation with a set of welldefined
positive and negative human samples (analyzed using gold standard methods). Performance
targets must be set by the study coordinator and Demonstration study can only be started if targets
have been met.
The results of Demonstration projects are compared against Customer Requirements, as stated by
Ministries of Health, the WHO and other international technical agencies, and donors. Data is
compiled, analyzed and presented to WHO for a policy recommendation on the use of these tests in
high-burden, low-income countries. In addition, the MOHs of countries that participated in the
Demonstration projects for these new tests may independently make a policy decision on their use.
As sponsor of clinical studies, FIND is responsible for the initiation and the professional conduct of a
clinical trial in compliance with established regulations. The FIND Head of Product Evaluation and
Demonstration (HPED) is responsible for the planning, direction, data management and data
evaluation of all studies under FIND sponsorship and are supported in these tasks by the project
leader. The HPED appoints a qualified FIND study coordinator who has the overall responsibility for a
study and who will supervise the organization, direction and reporting of a trial. FIND manages
standardized clinical trial planning for all its diagnostic projects since qualification of trial sites, in
particular for Evaluation studies in developing countries, is a prerequisite for generating reliable data
on clinical test performance, and the registration or adoption of tests.
Organization of clinical studies, including roles and responsibilities, planning, start of trials, study
performance and data management are described in the FIND Clinical Trial Standard.
6. REGULATORY AFFAIRS
FIND Regulatory Affairs provides support for the product launch plan for selected high-burden TB and
to the cooperation partner in the process of test registration in IVD-regulated developing countries.
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The manufacturer of a FIND-supported IVD is solely and fully accountable for conformity assessment
of the IVD as well as for all activities required for product registration under national or regional law.
The cooperation partner is responsible for the launch, distribution, service and market vigilance of the
diagnostic product in FIND target countries. The partner usually gets help from the Regulatory Affairs
offices of local affiliates, subcontracted companies or distribution agencies that are responsible for the
registration process. If diagnostic tests have been registered and distribution initiated, the commercial
partner is responsible for market vigilance of all products for diagnostic use. The partner has to notify
authorized bodies on adverse effects of the IVD and agrees to take responsibility for those activities in
the signed contract with FIND.
Any product-related adverse events affecting clinical trials are immediately reported to the cooperation
partner who is responsible for notifying legal authorities and implementing product improvements, as
necessary. FIND has a supporting function in the regulatory process.
7. LOGISTICS AND PURCHASE ORDERS
Responsibilities and processes for purchase ordering are described in the Standard Operating
Procedures. In the course of an in-vitro diagnostic test development, FIND’s project leaders and
medical officers will partner with clinical trial sites in high-burden countries to evaluate the IVD test
specificity and sensitivity in actual local settings. Together the project leader or the medical officer and
the trial site collaborator will plan a forecast for IVD consumption that is consistent with the clinical trial
protocol. For this, eight steps have been defined:
1. Clinical Trial Site request
2. Purchase Order draft
3. Shipping documents
4. Signatures
5. Tracking
6. Delivery confirmation
7. Payment
8. Archiving
8. PM SOP HIGHLIGHTS
8.1 Concept Definition phase and Milestone 1
CONCEPT PHASE ACTIVITIES:
• Describe project and project goals; propose partners, timeline and budget.
• Plan activities for Feasibility phase including: identify desired product target specifications for the
phase, partner selection and contract negotiation, plan/perform technical DD inspection, start
developing protocol for feasibility study/ies.
• Prepare milestone A (Concept) with documents for Concept review and Feasibility planning to
initiate next project phase (Feasibility).
MILESTONE 1 (CONCEPT DEFINED) DELIVERABLES:
Documents to be prepared for milestone 1 are summarized in table 2 below.
Table 2: Milestone 1 deliverables
Deliverables
Concept review Feasibility planning
• Concept Definition (CD)
• Customer Requirement Document (CRD)
• Feasibility Target Specification (FTS)
• Feasibility Plan
• Master Budget
• Timeline
• Risk Assessment and Mitigation Table
• Milestone A Checklist
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8.2 Feasibility phase and milestone 2
FEASIBILITY PHASE ACTIVITIES:
• Sign agreements with Feasibility partner(s).
• Perform technical due diligence inspection of partner.
• Develop, with partner(s), reagents or prototype-like products and prove feasibility of product
concept in Feasibility study(ies).
• Specify product design and select and negotiate contract/s with appropriate industrial partners for
development and manufacturing of IVD.
• Conduct first-pass analysis of: IP; manufacturing volume forecasts; and regulatory issues.
• Plan other activities for Development phase including: financial and GMP-IVD due diligence
inspections; study outline for Alpha trials.
• Prepare milestone B (Feasibility completed) with documents for Feasibility review and
Development planning to initiate next project phase (Development).
The Feasibility phase is based on documents completed during Concept Definition (Customer
Requirement Definition, Feasibility Plan, and Feasibility Target Specification).
MILESTONE 2 (FEASIBILITY COMPLETED) DELIVERABLES:
Documents to be prepared for this milestone are summarized in Table 3 below.
Table 3: Milestone 2 deliverables
Deliverables
Feasibility review Development planning
• Performance Report Feasibility
• Trial site list
• Contractual agreements
• Technical Due Diligence Inspection Report(s)
or Waiver
*If updated, or if this is the starting phase for the project
8.3 Development phase and Milestone 3
• Product Specification (PS)
• Development Plan
• Master Budget*
• Timeline*
• Risk Assessment and Mitigation Table*
• Milestone B Checklist
DEVELOPMENT PHASE ACTIVITIES:
• Prepare quality assessment of manufacturing partner’s processes and conduct financial and
GMP-IVD due diligence inspection Part A
• Sign agreement with development partner
• Develop with selected partner(s) the final IVD within projected timeline and budget
• Provide evidence that IVD prototype meets Product Specification to lock design and scale up
manufacturing
• Develop first draft of plan for product roll-out (scale-up)
• Plan other activities for Evaluation phase including: GMP-IVD Part B inspection; outline for
evaluation study/ies
• Prepare milestone D (Development completed) with documents for Development review and
Evaluation planning to initiate next project phase (Evaluation)
The Development phase is based on the Product Specification, Customer Requirement Document and
Development Plan.
The Development phase is not necessary if a product was developed by the partner without FIND
involvement and/or is ready for distribution in partner-target markets. FIND may subcontract such
partners for performance evaluation of their product in FIND-target markets. Such projects can enter
directly into the Evaluation phase once the approved MS 3 checklist and related document
deliverables have been completed.
Development studies for performance testing of final prototype (“Alpha” trial) must be planned and
conducted to prove Product Specification, lock product design and scale-up manufacturing for
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Evaluation study (“Beta” trial). Prototype studies can be conducted at one or more trial sites and can
be initiated once:
• FIND-supported product development is assumed to be completed and final prototype can be
manufactured.
• Contractual agreements for the purchase and dispatch of clinical trial materials have been
executed (or were already included in the binding agreement with the manufacturer).
• Clinical trial materials, such as test kits, reagents or instruments, can be shipped to the trial site.
Shipment of materials is only possible once an agreement with the trial site or trial partner has
been executed or is under negotiation.
• Trial sites have been inspected and certified to conduct Development studies for specific IVDs
according to FIND’s Clinical Trial Standard.
MILESTONE 3 (DEVELOPMENT COMPLETED) DELIVERABLES
Documents to be prepared for this milestone are summarized in Table 4 below.
Table 4: Milestone 3 deliverables
Deliverables
Development review Evaluation planning
• Performance Report Development
• Contractual agreements
• Trial Site Certificates
• Update trial site list*
• Financial Due Diligence Report
• GMP-IVD Due Diligence Inspection Part A
Report
• Regulatory Control Level Questionnaire
• Intellectual property report
*If updated, or if this is the starting phase for the project
8.4 Evaluation phase and milestone 4
• Evaluation Plan
• Master Budget*
• Timeline*
• Scale-up Plan
• Update Product Specification*
• Risk Assessment and Mitigation Table*
• Milestone D Checklist
EVALUATION PHASE ACTIVITIES:
• Prove clinical performance criteria of IVDs with Evaluation trials in controlled settings
• Make final quality assessment of manufacturing partner and conduct GMP-IVD due diligence
inspection Part B
• Plan activities for Demonstration phase
• Prepare milestone E (Evaluation completed) with documents for Evaluation review and
Demonstration planning to initiate next project phase (Demonstration)
The Evaluation phase can only be started once MS 3 checklist and related documents have been
signed off and milestone 3 has either been approved or an exemption from this rule has been granted
by the CEO.
The Evaluation phase anticipates the availability of design locked IVDs manufactured in compliance
with GMP-IVD standards or quality controlled manufacturing conditions. Products can be either FINDsupported
IVDs (proving achievement of product specification) or IVDs developed by partners without
FIND support (proving design locked IVD performance criteria): evaluation studies can be planned and
conducted for IVDs that are already commercially available.
The Evaluation phase is based on documents prepared in previous project phases (e.g. Customer
Requirement Definition, Product Specification and Evaluation Plan), and one of its major activities is
planning and conducting an Evaluation study to prove performance of design locked IVD (e.g. zero
production series or commercial IVD), and compare results with product specification.
The Evaluation study can be initiated once:
• Contractual agreements for the purchase and dispatch of clinical trial materials have been
executed.
• Incoming Quality Control (IQC) SOP has been prepared and validated by the manufacturer.
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• Clinical trial materials such as test kits, reagents or instruments can be shipped to the trial site.
Shipment of material is only possible once agreement with trial site or partner has been signed off
or is under negotiation.
• Trial sites have been inspected and certified to conduct Evaluation trials for specific IVDs
according to FIND standards, or waiver of trial site certification has been prepared.
The process of Outgoing Quality Control (OQC) of the IVD at the manufacturing site and IQC at the
clinical trial site following shipment of the IVD must be developed and implemented by the
manufacturer. Results must be recorded at the trial site and the project leader must approve lot
release for the study.
GMP-IVD due diligence inspection Part B has to be scheduled with the manufacturer when production
of subcontracted IVD has just begun.
Evaluation studies must take into consideration country regulatory requirements. Data can be used for
diagnostic product registration if studies have been conducted in compliance with country-specific
regulatory demands.
MILESTONE 4 (EVALUATION COMPLETED) DELIVERABLES
Documents to be prepared for this milestone are summarized in Table 5 below.
Table 5: Milestone 4 deliverables
Deliverables
Evaluation review Demonstration planning
• Performance Report Evaluation
• Evaluation study protocol
• Contractual agreements
• Trial Site Certification Reports
• Update trial site list
• GMP-IVD Due Diligence Inspection Part B
Report
• Intellectual property update
• Regulatory strategy update
*If updated
8.5 Demonstration phase and milestone 5
• Senior Management Meeting Record (if held)
• Demonstration Plan
• Customer Support Plan
• Update Scale-up Plan
• Master Budget*
• Timeline*
• Risk Assessment and Mitigation Table*
• Milestone E Checklist
DEMONSTRATION PHASE ACTIVITIES:
• Prepare and conduct large scale Demonstration studies to prove feasibility, performance of IVD
and utility under field conditions (real diagnostic routine conditions prevailing in target settings of
the IVD)
• Demonstrate accuracy and meaningful clinical impact outcomes for defined intended use of FIND
supported IVD
• Prepare dossier with sufficient data for submission to global and national health organizations and
institutions for endorsement of IVD or IVD-based technology (e.g. WHO endorsement)
• Start implementing laboratory support projects
• Prepare milestone F (Demonstration completed) with documents for Demonstration review and
Collecting Evidence for Scale-up planning to initiate next project phase
The Demonstration phase is scheduled for commercially available and registered (if necessary)
diagnostic products that may or may not have been manufactured with FIND support. Demonstration
studies are interventional studies in which results of the new IVD are used to manage patients in the
study group. Results from the study group will be compared with control group results.
Based on recommendations from FIND senior management and customer feedback, a protocol for the
Demonstration study will be prepared and sites and settings selected.
Data from the Demonstration study will be presented to the relevant WHO group for endorsement,
facilitating purchase of the new diagnostic and uptake in national health programmes. At the same
time, strategies to engage managers from national disease control programmes, senior policy makers
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in Ministries of Health of endemic countries, civil society, and donors have to take effect in order for
the FIND-supported IVD to be adopted and included in national health policies and guidelines.
As evidence begins to accumulate from laboratory preparedness studies, market adoption and scaleup
will be accelerated.
MILESTONE 5 (DEMONSTRATION COMPLETED) DELIVERABLES
Documents to be prepared for this milestone are summarized in Table 6 below.
Table 6: Milestone 5 deliverables
Deliverables
Demonstration review Collecting Evidence for Scale-up planning
• Performance Report Demonstration
• Demonstration study protocol
• Dossier for WHO
• Update trial site list
• Intellectual property*
• Update licensing for freedom to operate
*If updated
8.6 Collecting Evidence for Scale-up Phase and Milestone 6
• Update Scale-up Plan
• Update Customer Support Plan to include
Customer Support Table
• Risk Assessment and Mitigation Table*
• Milestone F Checklist
COLLECTING EVIDENCE PHASE ACTIVITIES:
The milestone is achieved if the National Disease Programmes of ≥ 2 high burden, resource poor
countries have approved the introduction of the technology in programmatic laboratory use.
MILESTONE 6 (UPTAKE IN ONE COUNTRY) DELIVERABLES
Documents to be prepared for this milestone are summarized in Table 7 below.
Table 7: Milestone 6 deliverables
Deliverables
*If updated
Collecting Evidence for Scale-up review Scale-up planning
• Evidence for Scale-up Report
• Update Customer Support Plan and Table*
8.7 Scale-up and Impact phase and Milestone 7
• Scale-up Plan
• Master Budget*
• Timeline*
• Risk Assessment and Mitigation Table*
• Milestone G Checklist
IMPACT PHASE ACTIVITIES:
• Draft and sign agreement with recipient countries
• Develop laboratory preparedness (phase 1)
- assess laboratory networks in recipient countries
- establish laboratory infrastructure to meet diagnostic requirements
- strengthening of quality assurance systems, along with the introduction and/or reinforcement
of SOPs
- ensuring training in Good Laboratory Practice, bio-safety and new diagnostic technologies for
introduction
- initiating policy reform on new diagnostic algorithms
• Introduce new diagnostics (phase 2)
- installing diagnostic instruments, procure reagents and other essential supplies
- integrating new diagnostics into diagnostic and treatment guidelines of National Disease
Programmes
• Assess impact of new diagnostics (phase 3)
- providing sustained technical assistance and mentoring to ensure proper use of new
diagnostics
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- measuring the impact of new diagnostics by monitoring and evaluation
MILESTONE 7 (IMPACT MONITORED) DELIVERABLES:
Documents to be prepared for this milestone are summarized in Table 8 below.
Table 8: Milestone 7 deliverables
Delvbls
Scale-up & Impact review
• Scale-up & Impact Report
• Milestone H Checklist End of project
9. MANAGEMENT OF NON-TYPICAL FIND PROJECTS
The project manager will decide whether a new project is a typical or non-typical project. Project
managers and project leaders should schedule a project initiation meeting (or a conference call) to
agree on the project framework (e.g. phases, milestones and documents to be prepared).
All non-typical projects will begin with a Concept phase and Milestone 1 (Concept defined).
Documents to be prepared for milestone 1 are summarized in Table 9.
Table 9: Milestone 1 deliverables for non-typical project (NTP)
Deliverables
Concept review Planning of next phase
• Concept Definition (NTP)
• Project Plan (NTP)
9.1 Monitoring of non-typical projects
• Phase Plan (NTP)
• Master Budget
• Timeline
• Risk Assessment and Mitigation Table
• Milestone A Checklist (NTP)
Non-typical projects will be monitored regularly at project management meetings since all project
management-related procedures also apply to non-typical projects. Mandatory documents for project
monitoring are Project News Updates (containing Milestone On-track Assessment Table and Risk
Assessment and Mitigation Table).
9.2 Milestones and deliverables of non-typical projects
Performance reports of previous phase (Phase Reports) must be prepared and approved for each
milestone of non-typical projects. A Phase Report is produced describing achievements and
comparing set phase targets with attained goals. Decisions will be made on project continuation and
targets of next Phase Plan during the FIND milestone review process.
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