New Study Information Form
This New Study Information Form should be submitted to GEP (gep@purdue.edu) by Friday,
January 29, 2016.
I.
Investigator Information
Project Title
Click here to type project title
Principal Investigator
Name: PI Last Name, PI First Name
Primary Institutional Affiliation: Select Primary Institutional Affiliation
Postal Address:Enter Street Address/ PO Box, City, State/Providence, Postal Code, Country
Telephone: +0-000-0000Fax: +0-000-0000E-mail:jdoe@university.edu
Co-Principal Investigator
Name: PI Last Name, PI First Name
Primary Institutional Affiliation: Select Primary Institutional Affiliation
Postal Address:Enter Street Address/ PO Box, City, State/Providence, Postal Code, Country
Telephone: +0-000-0000Fax: +0-000-0000E-mail:jdoe@university.edu
AMPATH Consortium Collaborator
Would you like assistance in identifying a collaborator from an AMPATH consortium member
institution?
☐Yes ☐No
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II.
Study Summary
Project Areas of Focus
Which of the following areas of focus best describe this study? (Select all that apply)
☐Adult Medicine
☐Laboratory
☐Public Health & Primary Care
☐Basic Science
☐Nutrition
☐Reproductive Health
☐Behavioral & Social Science
☐Oncology
☐Tuberculosis
☐Bioethics
☐Pediatrics
☐Other:(Please Describe)
☐Cardiovascular & Metabolic Disease
☐Pharmacy
☐Informatics
☐PMTCT
Study Type
This study will be a:
☐ Retrospective Cohort ☐ Prospective Cohort ☐Clinical Trial X Other: Innovation development
and piloting
Primary Objectives
Please list the primary objectives of your proposed study.
These may be proposed objectives. Reasonable to pull from I2D Lab-CGFS Priority Challenge
Topics, and/or adapt appropriately given personal research interests.
Project Description
Please provide a 1-2 paragraph description of your proposed study.
These may be proposed objectives. Reasonable to pull from I2D Lab-CGFS Priority Challenge
Topics, and/or adapt appropriately given personal research interests.
Funding Status
Has funding been secured for this project?
☐ Yes, please list project sponsors: Click here to enter text.
X No, please describe where funding will be sought: I2D Lab – CGFS Joint Seed Grant Program
Funding Application Deadline: 3/4/2016
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Proposed project budget:
For undergraduate team proposals involving Engineering PIs only, up to $7,500 will be
provided. For proposals focused on food security and involving an Engineering PI and nonEngineering co-PIs, up to $10,000 will be provided. Part of the award must be used towards
offsetting student travel costs when they accompany the PI to visit AMPATH. Additionally, these
funds may be used for project supplies.
For graduate research proposals involving Engineering PIs only a one-year a grant of up to $25,000
total ($21,000 graduate assistantship, $4,000 S&E and travel) can be requested. For proposals
focused on food security and involving an Engineering PI and non-Engineering co-PIs, a one-year
grant of up to $30,000 total ($21,000 graduate assistantship, $9,000 S&E and travel) can be
requested.
Project Deadlines
Please list key project deadlines.
March 4: Deadline for submitting proposals March 30: Announcement of seed grant recipients April
1: I2D Lab ExpositionAwarded projects may begin in Summer or Fall 2016[Add proposed project
timeline]
Project Deliverables
Please describe any deliverables for this project (e.g. abstract, grant proposal, manuscript,
prototypes, etc.).
Click here to enter text.
Approvals
Has this study received any of the following approvals prior to routing?
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III.
Research Working Group Approval:☐ Yes X No ☐ Pending
AMPATH Data Analysis Team Approval:☐ Yes X No ☐ Pending
Institutional Review and Ethics Committee Approval:☐ Yes X No ☐ Pending
Export/Import Permits for Laboratory Specimens:☐ Yes X No ☐ Pending
Biostatistics & Data Requirements
Projects requiring access to AMPATH Medical Record System (AMRS) data, lists of eligible
AMPATH study participants, sample size calculations, data analysis services, and/or other AMPATH
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biostatistics and data management services must be reviewed by the AMPATH Data Analysis Team
(ADAT).Please complete the following section to request ADAT review of your project
Study Population
Please describe the population you plan to study including your proposed
inclusion/exclusion criteria and rationale.
If human subjects are to be engaged during research and development of your project, describe the
population(s) and their value/importance to the work. If the involvement of human subjects is
deemed necessary/appropriate for this work, a study proposal and IRB approval will be sought.
Sampling Methods
Please describe the proposed sampling methods and statistical analysis for this study.
Not applicable at this time
Dependent Variables
Please describe the dependent variable (outcome) for this study (be specific as possible).
Not applicable at this time
Independent Variables
Please describe the independent variables included in your study and, where necessary,
listing of relevant confounders or auxiliary variables that will be needed.
Not applicable at this time
AMPATH Data Source Forms
Please list the AMPATH forms and corresponding items that will provide the source data for
your proposed dependent and independent variables (Currently available at:
https://wiki.ampath.or.ke/display/forms/AMPATH+Form+Development+Team+Homepage)
Not applicable at this time
Project Statistician
Name: Not applicable at this time
Primary Institutional Affiliation: Select Primary Institutional Affiliation
Postal Address:Enter Street Address/ PO Box, City, State/Providence, Postal Code, Country
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Telephone: +0-000-0000Fax: +0-000-0000E-mail:jdoe@university.edu
IV.
Lab Requirements
This section should be completed by investigators who plan to use laboratory resources for their
project. The information provided in this section is routed to the AMPATH Reference Laboratory for
scoping and costing laboratory services for clinical study and research use.
The AMPATH Reference Laboratories provide a wide range of validated and externally quality
controlled diagnostic tests. The laboratories operate in accordance with advice from Patient Safety
Monitoring in International Laboratories (pSMILE). pSMILE assisted with a comprehensive list of
Standard Operating Procedures (relevant procedures available on request). The labs will follow
these Standard Operating Procedures when processing study samples unless otherwise agreed.
In case the test requested is not among the tests performed in the lab and the lab has capacity to
perform this test, the lab will seek to validate the test before it is performed for the project and the
costs of validation will be borne by the project. If a study plans to provide equipment, materials and
reagents including associated supplies, the lab will be obliged to charge tech time and overheads.
Note that AMPATH Reference Lab is not authorized to provide any data other than patient
information for immediate patient care, or data generated as part of dedicated research to
authorized persons. Clinical Study and Research work has to be fully funded. Funding availability
does not guarantee Ref Lab participation. The application needs to be compatible with the work flow
of the laboratory and ethical approval from relevant bodies needs to be obtained.
Lab Testing Algorithm
Is the algorithm of lab testing known? ☐ Yes ☐ No
Has the algorithm been included with this proposal submission? ☐ Yes ☐ No
Please describe the proposed testing schedule, test volume, and test repertoire including if
the results are required real time or batched as this may have cost implications. Contact lab
manager.
Not applicable at this time
Covered Tests
Are all of the proposed tests covered by the current test list? ☐ Yes ☐ No
Please note that investigators are encouraged to include all desired tests within the lab budgets for
their studies. Erratic supplies of reagents have made clinical lab tests within the AMPATH Clinics
less dependable and relying on clinical tests may result in incomplete or missing data.
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Special Processing Requirements
Will any special processing of specimens or isolates be required for this study? ☐ Yes ☐ No
If yes, please describe the requirements.
Not applicable at this time
Sample Storage Requirements
Are there any special archive requirements for sample storage (e.g. cold storage)?
☐ Yes, how long will samples require storage? Click here to enter text.
☐ No
Do samples need to be destroyed according to a special protocol?☐ Yes ☐ No
Do samples need to be shipped? ☐ Yes ☐ No
Please describe any special requirements for the storage or shipment of specimens.
Not applicable at this time
Note that the AMPATH Lab has trained and certified staff for IATA compliant shipments (ambient
and frozen). The lab charges for sample storage.
Data Storage Requirements
Are there any special data storage or confidentiality requirements for your lab data? ☐ Yes X
No
Please describe any special requirements for data storage.
Not applicable at this time
Staff Requirements
Does your project have any special requirements for laboratory staff?☐ Yes X No
Are there requirements for work to be undertaken outside of ordinary working hours?☐ Yes
X No
Describe any specifications for staff assigned to the study. Note that the AMPATH Lab has a
pool of staff trained in clinical studies work and will assign the staff most suited to the test
profile or shipping requirements, unless otherwise agreed. The lab policy does not allow for
individual payments to techs for work done. The lab manager will provide the charges for
tech time.
Not applicable at this time
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