SRH Research Proposal Form - Infectious Diseases Institute

IDI Use Only; Please Do Not Write Here:
Date Received__________
Date Approved by SRC________ Date Returned by SRC for Revisions________
Date Forwarded to Ethics Committee________ Date Approved by Ethics Committee________
Date of Final Implementation Agreement with IDI______
INFECTIOUS DISEASES INSTITUTE
Research Project Proposal Form
This form is meant to capture additional important information that may not be captured in the protocol. It is not meant to duplicate
information. It is acceptable to refer to sections of the protocol if the information is captured therein. Do not delete sections. Use
Times New Roman 10 Point Font to complete the information
Section A:
Project Cover Sheet
Research Project Title: ______________________________________________________________
Type of Study (check one):
__observational __Clinical Trial (Phase 1 __Phase 2 __Phase 3___)
__other (describe):
IDI Research Study Number: ___________________
Study Protocol submitted with this form _____ Yes _____No (explain):
____________________________________
ICD Attached _____Yes _____No
List other forms attached:
Version #
___________________________________
___________________________________
___________________________________
___________________________________
Study Hypothesis (problem statement) and Study Questions
These should be brief and correspond to the objectives and endpoints in the protocol. It should not exceed
200 words.
Please indicate the name and contact information of the person who will present the proposal at the
Scientific Review Committee.
Investigators (Principal Investigators first)
Please list all investigators and collaborators (Note: The PI should be a fully credentialed professional and if
still in training, work under the authority of the one. A Uganda-based co-PI is required)
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Name Institution PI/Co-PI/Co-Investigator
Which IRB will review the proposal
Section B:
Study Conduct
Studies involving human subjects:
How will informed consent be obtained
How will confidentiality of the data gathered be ensured
Attach your consent form, subject information sheet, and questionnaire (if applicable). If you are
unable to attach any of these please use the box below to explain why not.
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What samples if any, will be taken and what investigations will be conducted Please justify
volumes to be taken. This section should describe any biological samples that will be collected, how they
will be collected processed, stored and destroyed. Importantly, the reason for collection of these samples
should be included. Particular importantce should be placed on samples collected outside routine,
standard of care samplingSome questions to consider:
1. What type of samples will be collected (e.g whole blood, plasma, tissue, urine)
2. Are special kits required
3. How will these be used to support the primary or secondary objectives How many samples will
be collected (justify the volumes)
4. Is the collection of these samples mandatory or optional (this should be included in the ICF)
5. Will the MU-JHU Core Lab be used (if yes, a lab agreement will need to be signed)
6. Is there any special handling of these samples (e.g. centrifugation, refrigeration)
7. What is the long-term stability of the samples
8. Where and how long will these samples be stored and/or shipped
9. How will samples be stored/destroyed at the end of the study
Expected Outputs and Dissemination of Results
What are the expected outputs (e.g presentations, publications, study reports) from this project
Will interim results, if available be reported
Capacity Building:
How will this project build capacity at IDI and/or Makerere University
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Section C:
Operational Considerations
Study sites
List the sites (clinic/hospital name and location) where the study will be conducted
Proposed Start Date and Duration
Recruitment: Estimated # of Patients/Month
______________________________________
_______________________________________
Important Dates: List important dates (chronologically) below. In the comments section provide
additional information as to why it is important or not applicable
Milestone Date Comments
Contract Signed
First Subject First Visit
Interim analysis
Meeting/Congress presentation
Last Subject Last Visit
Database Lock
Final Study Report
Other (as needed)
Give a brief overview of how the project will be staffed. This should specifically include a Study
Coordinator, Medical Officer and Study Nurse.
Give a brief overview of key facilities and equipment requirements for this study. Include any
specific IT needs (i.e. computers, phones, phone cards, software)
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Give a brief overview of data management requirements; please indicate who will be responsible for
data management activities.
Section D: Ethical Considerations
In addition to reviewing the answers to these questions, the committee will evaluate the consent form and
patient information sheets to ensure that they are simple enough to be understood by study participants.
Please indicate on your consent form/patient information sheet which language(s) they will be translated
into and whether they will be cross-translated to check for accuracy.
Outline how the study will contribute to improving the health of people in Uganda.
Summarize the potential risks and benefits to individuals and communities.
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Section E: Budget This section will be filled out during your initial meeting with the Head of Operations
and Finance. Please add as many rows as necessary to give a comprehensive picture of the study budget.
Item Unit Cost Multiplied
by
(# of days, #
of people,
Multiplied
by
(# of days, #
of people,
Overall Cost Notes
quantity quantity
required, etc.) required,
etc.)
Contracted project
staff
Indicate position title, rate,
effort, duration, and overall
cost
IDI Staff
Indicate position title, rate,
effort, duration, and overall
cost
Office, lab, clinical
space
Indicate location, rate,
duration, and overall cost
Research costs
Indicate individual costs for
drugs, lab tests, and
supplies
Sample Management
Will samples be stored
Where How long Each
sample type (e.g urine,
blood, tissue) should be
listed separately
Shipping costs
Storage/Archiving
costs (paper)
Indicate the costs for the
storage of Study Materials
according to the records
retention plolicy
IDI equipment
Indicate all clinical
equipment, CIT and
laboratory equipment;
calculate costs based on
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level of use
Administrative
supplies,
communications,
transport
Indicate general categories
of costs (i.e. photocopies,
phone calls, etc.)
Travel and
conferences
Indicate descriptions of
meetings/conferences, cost
per participant, frequency,
and overall cost per
meeting/conference
Capital procurement
Indicate major and minor
equipment, and note who
will procure equipment
Field expenses
Indicate all field activities
including participant
recruitment, home visits,
etc.
Total Budget:
Plans for Funding Study
Describe sources and amounts of the funding. If any important milestones (start-dates, duration, etc) are
attached as a condition of the funding, describe.
Grantor
Amount
Requested
Amount
Committed
Amount Received
Milestones (describe)
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Section F:
Declarations
Confidentiality: Applications will normally be made accessible to all IDI senior staff. If for reasons of
commercial, ethical or scientific sensitivity you wish to restrict access/circulation to Scientific Review
Committee members, please indicate here.
Restrict access to Scientific Review Committee members Yes
No
Please sign the following statements:
The principal investigator agrees to the internal monitoring standards and processes of the IDI. These
may be superseded by specific requests by the IRB:
Signature of Principal Investigator ……………………………………………………..
The principal investigator undertakes to leave with the Data Management team at the IDI, a complete
copy of the data set at the following two time points:
1. After data entry and verification (raw data sets)
2. At the point of submission for publication of final report (analysis data sets)
Signature of Principal Investigator ……………………………………………………..
The principal investigator undertakes to leave with the IDI appropriate aliquots of the biological material
being taken out of the country as applicable and only as approved by IRB and UNCST.
Signature of Principal Investigator ……………………………………………………..
The principal investigator undertakes to leave with the IDI all equipment procured for the purpose of this
project.
Signature of Principal Investigator ……………………………………………………..
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Projects taking place at the IDI facility will have to undergo operational and scientific review prior to
imitation and whenever possible, these reviews should occur prior to local IRB review. Important
contacts of IDI leadership are listed below for consultation.
Staff Member Consulted
Head of Clinical Services, Dr. Rosalind
Parkes Ratanshi 031-307237
rratanshi@idi.co.ug
Head of Lab (Ali Elbireer); 041-307260;
aelbireer@idi.co.ug)
Head of Research Dr. Andrew Kambugu;
031-307227 akambugu@idi.co.ug)
Head of Finance and Operations (Fred
Wangolo); 0312-250500;
fwangolo@idi.co.ug)
Head, Information Services
Peter Okwi; pokwi@idi.co.ug 0312-
307225;
Situations in which
consultation is
necessary
Projects taking place
in the IDI clinic
Projects utilizing MU-
JHU laboratory
facilities and/or
storage space
All projects
All projects; this
consultation will cover
use of IDI staff.
All projects; will
handle data
management
capacities
Comments or Concerns; if fully endorsed, please
indicate
IDI Cohort Coordinator ( Barbara
Castelnuovo); 0312-307300;
bcastelnuovo@idi.co.ug
Regulatory Lead (Michael Enyakoit) 0414 –
307226 menyakoit@idi.co.ug
Research Office (Allen Mukhwana) 0414 -
307242 amukhwana@idi.co.ug
All projects; will
handle data sharing
policy
All projects / GCP
compliance
All projects
Status of Relevant Approvals from Other Participating Institutions
Participating Institution
Role (e.g. site, funding source,
etc.)
Institutional Approval Status
Approved Pending Other (explain)
I declare that all information contained in this form is correct to the best of my knowledge.
Signature of principal investigator:
Date:
________________________________________________________________________
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