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Project Charter
PRIVATE/PROPRIETARY
73616f55-3a97-4afa-aaf7-c6661fd75c56-150314104858-conversion-gate01
Page 1
EBOCT TECHNOLOGIES
Project
Name Autism Spectrum disorders
Project
Number 1001
Project
Manager Richard Johnson Prioritization High
Owner(s)
Department of Health and Human Services
National Institutes of Health (NIH)
Start Date: 01/01/2012
Scheduled
Completion
Date:
12/31/2012
Mission
Support the research designed to elucidate the etiology, epidemiology,
diagnosis, treatment, and optimal means of service delivery in relation to
autism spectrum disorders (ASD).
Scope
Set and Identify three stages that effect autism children that were designed
to elucidate the etiology, epidemiology, diagnosis, treatment, and optimal
means of service delivered in relations to autism spectrum disorders. The
three stages that would be used are characterized as follow:
Deliverables:
1) Mild case stage
Elucidate the etiology study
Epidemiology study
Diagnosis study
Treatment study
Optimal means of service study
Results
2) Intermediate case stage
Elucidate the etiology study
Epidemiology study
Diagnosis study
Treatment study
Optimal means of service study
Results
3) Serious case stage
Project Charter
PRIVATE/PROPRIETARY
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Page 2
Elucidate the etiology study
Epidemiology study
Diagnosis study
Treatment study
Optimal means of service study
Results
Under these three stages, research would be done to facilitate whether or
not the method being used is feasible to the condition of autism children
and adults.
The research would be based on the service portion of obtaining information
in the following manner:
Services Projects:
 Studies to understand how specific types of services,
organizational processes and structures, financing
mechanisms and evolving technologies and policies affect
access to and delivery of services to people with ASD.
 Studies that include children, as well as transition-age youth
and adults.
 Studies on adults that include strategies that enable post-
secondary education, supported employment, health care and
community integration.
Other priorities include but are not limited to:
 Identification of risk factors (e.g., viruses, medications,
immune dysfunctions, mitochondrial abnormalities,
environmental chemicals, genetics) that contribute to the
development of autism and their associated developmental
windows.
 Identification of biological signatures for autism and their
relevance to prediction of treatment response and outcomes.
 Assessment of characteristics and evaluation of interventions
in understudied populations (e.g. adults, individuals from
Project Charter
PRIVATE/PROPRIETARY
73616f55-3a97-4afa-aaf7-c6661fd75c56-150314104858-conversion-gate01
Page 3
racial and ethnic minorities) and in those with comorbid
conditions (e.g. epilepsy).
 Studies that improve the understanding of underlying biologic
pathways that might lead to treatments for genetic conditions
related to autism. NINDS is particularly interested in
mechanistic analyses of single gene disorders with autistic
features (e.g. Tuberous Sclerosis Complex, Rett syndrome,
Fragile X syndrome) that may shed light on pathways that are
relevant to autism.
EBOCT research center will collaborate with the Collaborative Programs of
Excellence in Autism (CPEA), the Studies to Advance Autism Research
and Treatment’ (STAART), and INTERNET to better understand the reason
and purpose for research that was designed to elucidate the etiology,
epidemiology, diagnosis, treatment, and optimal means of service rendered
through the ACE program. Our goals and objectives will be a collaboration
with other centers who can share information that will help establish the
three stages associated with this research. One key resource is the
Children Specialized Hospital for Autism, located in Mountainside New
Jersey.
Objectives
Solidify the procedures used to elucidate the etiology, epidemiology,
diagnosis, treatment, and optical means of services delivered in
relations to autism spectrum disorders.
The estimated time would be 12 months from the awarding of the
contract to EBOCT Technologies research center.
The cost would be estimated as being $607,660.00 Including expenses
(allowed under the agreement of the contract).
Assumptions There would be three (3) investigators working on this project, and are
listed as follow:
Project Charter
PRIVATE/PROPRIETARY
73616f55-3a97-4afa-aaf7-c6661fd75c56-150314104858-conversion-gate01
Page 4
1) Principal Investigator (PI)
2) Senior research person
3) Assistant research person
All work will be documented and reported (according to the
specification listed in the contract) to the Department of Health and
Human Services or according to their expectations in receiving these
reports.
EBOCT research center will collaborate with the Collaborative
Programs of Excellence in Autism (CPEA), the Studies to Advance
Autism Research and Treatment’ (STAART), and INTERNET to better
understand the reason and purpose for research that were designed to
elucidate the etiology, epidemiology, diagnosis, treatment, and optimal
means of service rendered through the ACE program. Our goals and
objectives will be a collaboration with other centers who can share
information that will help establish the three stages associated with
this research. One key resource is the Children Specialized Hospital
for Autism, located in Mountainside New Jersey.
Constraints In the case of bad weather or conditions that might prevent EBOCT
from working on the project, within 48 hours, a written document would
be created explaining reasons why during the period of down time such
activity did occur and the consequences behind it.
Time/Decision
Points During the research process, EBOCT plans to host a total of 5 group
meetings in the following manner.
1st group meeting month 3
2nd group meeting month 5
3rd group meeting month 8
4th group meeting month 10
5th group meeting month 12
During this time progress reports will be given and referenced to the
findings and behavior of Autism in children and Adults. Each session
Project Charter
PRIVATE/PROPRIETARY
73616f55-3a97-4afa-aaf7-c6661fd75c56-150314104858-conversion-gate01
Page 5
will be recorded and presented to the NIH.
Cost/Financial
Assumptions
Startup Cost: 2012
Budget item
Request
ed
Contribut
ed
Labor:
Principal Investigator (PI) $208,000
Labor:
Research Investigator #1 $41,600
Labor:
Research Investigator #2 $35,360
Labor:
Secretary $31,200
Labor:
N/A 0.00
LABOR SUBTOTAL $316,160 $0
Travel expenses (i.e. meals, lodging, etc): $10,000
Field/site visits $20,000
Conferences/meetings $6,000
Miscellaneous cost $60,000
TRAVEL SUBTOTAL $96,000 $0
Capitalized equipment: $15,000
Computers $12,000
Software $10,000
DSL Connection 1-yr $12,000
EQUIPMENT SUBTOTAL $49,000 $0
Materials and supplies $6,500
MATERIALS AND SUPPLIES SUBTOTAL $6,500 $0
Cable laying $6,000
OTHER SUBTOTAL $6,000 $0
TOTAL DIRECT COSTS $473,660 $0
Indirect costs (no more than 20% of direct costs): $94,000
Pass-through if applicable (no more than 10% of direct
costs): $40,000
TOTAL INDIRECT COSTS $134,000 $0
Project Charter
PRIVATE/PROPRIETARY
73616f55-3a97-4afa-aaf7-c6661fd75c56-150314104858-conversion-gate01
Page 6
TOTAL REQUESTED FUNDING $607,660
TOTAL CONTRIBUTED FUNDING $0
User Acceptance
Criteria/Quality
Use state of the art equipment and tactics in researching and
completing data information that pertains to the development
knowledge of understanding and identifying the three stages; Mild,
Intermediate, and Serious cases involved in autism, and designed
to elucidate the etiology, epidemiology, diagnosis, treatment, and
optimal means of service delivered in relations to autism spectrum
disorders. This research will determine whether or not the method
used is feasible, and recognized in the above cases which are
designed to elucidate the etiology, epidemiology, diagnosis,
treatment, and optimal means of service. Our findings will be
notarized, and presented to the NIH according to the contract
agreement.
Major
Risks 1) Bad weather may occur.
2) Research facility may be closed due to conditions uncontrolled by
EBOCT.
3) Electrical outages, and or computer outages may occur.
4) Misleading data information
5) Theft may occur.
_________________________________________
SOLUTIONS:
1) All efforts will be made to meet deadlines presented in the
contract.
2) All dates will be governed for accuracy
3) Backup UPS will be provided
4) All data will be signed by the facility or persons in charge of such
data.
5) EBOCT will be alarmed, and a backup data system will be put at a
Project Charter
PRIVATE/PROPRIETARY
73616f55-3a97-4afa-aaf7-c6661fd75c56-150314104858-conversion-gate01
Page 7
secondary location for security purposes.
Project Charter
PRIVATE/PROPRIETARY
73616f55-3a97-4afa-aaf7-c6661fd75c56-150314104858-conversion-gate01
Page 8
KEY STAKEHOLDERS
Name
Project Core
Team: Project Manager
Principal Investigator (PI)
Senior research investigator
Assistant research investigator
Investigator Secretary
Subject Matter
Experts (SME)
(Include company
& channel
designations if
applicable)
N/A
APPROVALS
Type Name Signature Date
Project Manager Approval:
Richard Johnson
Owner/Sponsor Approval:
National Institutes of Health
(NIH)

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NIH Project Charter_

  • 1. Project Charter PRIVATE/PROPRIETARY 73616f55-3a97-4afa-aaf7-c6661fd75c56-150314104858-conversion-gate01 Page 1 EBOCT TECHNOLOGIES Project Name Autism Spectrum disorders Project Number 1001 Project Manager Richard Johnson Prioritization High Owner(s) Department of Health and Human Services National Institutes of Health (NIH) Start Date: 01/01/2012 Scheduled Completion Date: 12/31/2012 Mission Support the research designed to elucidate the etiology, epidemiology, diagnosis, treatment, and optimal means of service delivery in relation to autism spectrum disorders (ASD). Scope Set and Identify three stages that effect autism children that were designed to elucidate the etiology, epidemiology, diagnosis, treatment, and optimal means of service delivered in relations to autism spectrum disorders. The three stages that would be used are characterized as follow: Deliverables: 1) Mild case stage Elucidate the etiology study Epidemiology study Diagnosis study Treatment study Optimal means of service study Results 2) Intermediate case stage Elucidate the etiology study Epidemiology study Diagnosis study Treatment study Optimal means of service study Results 3) Serious case stage
  • 2. Project Charter PRIVATE/PROPRIETARY 73616f55-3a97-4afa-aaf7-c6661fd75c56-150314104858-conversion-gate01 Page 2 Elucidate the etiology study Epidemiology study Diagnosis study Treatment study Optimal means of service study Results Under these three stages, research would be done to facilitate whether or not the method being used is feasible to the condition of autism children and adults. The research would be based on the service portion of obtaining information in the following manner: Services Projects:  Studies to understand how specific types of services, organizational processes and structures, financing mechanisms and evolving technologies and policies affect access to and delivery of services to people with ASD.  Studies that include children, as well as transition-age youth and adults.  Studies on adults that include strategies that enable post- secondary education, supported employment, health care and community integration. Other priorities include but are not limited to:  Identification of risk factors (e.g., viruses, medications, immune dysfunctions, mitochondrial abnormalities, environmental chemicals, genetics) that contribute to the development of autism and their associated developmental windows.  Identification of biological signatures for autism and their relevance to prediction of treatment response and outcomes.  Assessment of characteristics and evaluation of interventions in understudied populations (e.g. adults, individuals from
  • 3. Project Charter PRIVATE/PROPRIETARY 73616f55-3a97-4afa-aaf7-c6661fd75c56-150314104858-conversion-gate01 Page 3 racial and ethnic minorities) and in those with comorbid conditions (e.g. epilepsy).  Studies that improve the understanding of underlying biologic pathways that might lead to treatments for genetic conditions related to autism. NINDS is particularly interested in mechanistic analyses of single gene disorders with autistic features (e.g. Tuberous Sclerosis Complex, Rett syndrome, Fragile X syndrome) that may shed light on pathways that are relevant to autism. EBOCT research center will collaborate with the Collaborative Programs of Excellence in Autism (CPEA), the Studies to Advance Autism Research and Treatment’ (STAART), and INTERNET to better understand the reason and purpose for research that was designed to elucidate the etiology, epidemiology, diagnosis, treatment, and optimal means of service rendered through the ACE program. Our goals and objectives will be a collaboration with other centers who can share information that will help establish the three stages associated with this research. One key resource is the Children Specialized Hospital for Autism, located in Mountainside New Jersey. Objectives Solidify the procedures used to elucidate the etiology, epidemiology, diagnosis, treatment, and optical means of services delivered in relations to autism spectrum disorders. The estimated time would be 12 months from the awarding of the contract to EBOCT Technologies research center. The cost would be estimated as being $607,660.00 Including expenses (allowed under the agreement of the contract). Assumptions There would be three (3) investigators working on this project, and are listed as follow:
  • 4. Project Charter PRIVATE/PROPRIETARY 73616f55-3a97-4afa-aaf7-c6661fd75c56-150314104858-conversion-gate01 Page 4 1) Principal Investigator (PI) 2) Senior research person 3) Assistant research person All work will be documented and reported (according to the specification listed in the contract) to the Department of Health and Human Services or according to their expectations in receiving these reports. EBOCT research center will collaborate with the Collaborative Programs of Excellence in Autism (CPEA), the Studies to Advance Autism Research and Treatment’ (STAART), and INTERNET to better understand the reason and purpose for research that were designed to elucidate the etiology, epidemiology, diagnosis, treatment, and optimal means of service rendered through the ACE program. Our goals and objectives will be a collaboration with other centers who can share information that will help establish the three stages associated with this research. One key resource is the Children Specialized Hospital for Autism, located in Mountainside New Jersey. Constraints In the case of bad weather or conditions that might prevent EBOCT from working on the project, within 48 hours, a written document would be created explaining reasons why during the period of down time such activity did occur and the consequences behind it. Time/Decision Points During the research process, EBOCT plans to host a total of 5 group meetings in the following manner. 1st group meeting month 3 2nd group meeting month 5 3rd group meeting month 8 4th group meeting month 10 5th group meeting month 12 During this time progress reports will be given and referenced to the findings and behavior of Autism in children and Adults. Each session
  • 5. Project Charter PRIVATE/PROPRIETARY 73616f55-3a97-4afa-aaf7-c6661fd75c56-150314104858-conversion-gate01 Page 5 will be recorded and presented to the NIH. Cost/Financial Assumptions Startup Cost: 2012 Budget item Request ed Contribut ed Labor: Principal Investigator (PI) $208,000 Labor: Research Investigator #1 $41,600 Labor: Research Investigator #2 $35,360 Labor: Secretary $31,200 Labor: N/A 0.00 LABOR SUBTOTAL $316,160 $0 Travel expenses (i.e. meals, lodging, etc): $10,000 Field/site visits $20,000 Conferences/meetings $6,000 Miscellaneous cost $60,000 TRAVEL SUBTOTAL $96,000 $0 Capitalized equipment: $15,000 Computers $12,000 Software $10,000 DSL Connection 1-yr $12,000 EQUIPMENT SUBTOTAL $49,000 $0 Materials and supplies $6,500 MATERIALS AND SUPPLIES SUBTOTAL $6,500 $0 Cable laying $6,000 OTHER SUBTOTAL $6,000 $0 TOTAL DIRECT COSTS $473,660 $0 Indirect costs (no more than 20% of direct costs): $94,000 Pass-through if applicable (no more than 10% of direct costs): $40,000 TOTAL INDIRECT COSTS $134,000 $0
  • 6. Project Charter PRIVATE/PROPRIETARY 73616f55-3a97-4afa-aaf7-c6661fd75c56-150314104858-conversion-gate01 Page 6 TOTAL REQUESTED FUNDING $607,660 TOTAL CONTRIBUTED FUNDING $0 User Acceptance Criteria/Quality Use state of the art equipment and tactics in researching and completing data information that pertains to the development knowledge of understanding and identifying the three stages; Mild, Intermediate, and Serious cases involved in autism, and designed to elucidate the etiology, epidemiology, diagnosis, treatment, and optimal means of service delivered in relations to autism spectrum disorders. This research will determine whether or not the method used is feasible, and recognized in the above cases which are designed to elucidate the etiology, epidemiology, diagnosis, treatment, and optimal means of service. Our findings will be notarized, and presented to the NIH according to the contract agreement. Major Risks 1) Bad weather may occur. 2) Research facility may be closed due to conditions uncontrolled by EBOCT. 3) Electrical outages, and or computer outages may occur. 4) Misleading data information 5) Theft may occur. _________________________________________ SOLUTIONS: 1) All efforts will be made to meet deadlines presented in the contract. 2) All dates will be governed for accuracy 3) Backup UPS will be provided 4) All data will be signed by the facility or persons in charge of such data. 5) EBOCT will be alarmed, and a backup data system will be put at a
  • 8. Project Charter PRIVATE/PROPRIETARY 73616f55-3a97-4afa-aaf7-c6661fd75c56-150314104858-conversion-gate01 Page 8 KEY STAKEHOLDERS Name Project Core Team: Project Manager Principal Investigator (PI) Senior research investigator Assistant research investigator Investigator Secretary Subject Matter Experts (SME) (Include company & channel designations if applicable) N/A APPROVALS Type Name Signature Date Project Manager Approval: Richard Johnson Owner/Sponsor Approval: National Institutes of Health (NIH)