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Proposal Format

The Protocol submitted to the Committee should be in the following sections:

Title page
This page should have the title of the Protocol and the names, addresses, e-mail, departments and affiliations of Investigators.

Structured abstract (it should be between half and one page and must not have references)
i. Background
ii. General Aim
iii. Methodology
iv. Expected Outcome (expected results or what you hope to achieve from study)

Background including rational, relevance and innovation (Limit of 1-2 pages)

Hypothesis (if applicable)/Research question (if applicable)

The expected association/relationship between one or more independent variables and the dependent variable, which the study will establish.

Aim(s)
What is expected to be achieved? Proposal must typically have one or two broad aim (s).

Specific objectives
Proposal may have several immediate or specific objectives. This describes the specific action or experiment(s) that will be undertaken to achieve the broad aim(s).

Proposal Format

Literature review
Limit of 3 pages for literature review

Methodology (limit 5 pages for methodology)

Study design:
Human studies- could be retrospective (case-control), prospective (cohort, clinical trial, case-control) or cross-sectional and others as appropriate

Study sites
Describe site briefly including facilities available

Subjects/study population
Inclusion/exclusion criteria
Provide inclusion and exclusion criteria appropriately.

Sample size determination
Use appropriate determination for type of study

Procedures to be used
i. Data collection methods and instruments.
ii. Should be reproducible by other investigators
iii. Needs to be precise.

Data handling
May include
i. Coding
ii. Quality control (pre-testing, supervision, training) measures.
iii. Data security and confidentiality

Statistical analysis
i. Descriptive statistics (frequency, central tendencies, associations)
ii. Inferential statistics (test of means, correlation coefficient, etc)
iii. Others

Dissemination of results
i. To Project sponsors, policy makers and study participants (where applicable)
ii. At workshops, seminars and conferences
iii. In different types of publications
iv. Korle Bu website

Ethical issues
For Human Subjects
i. Consider Recruitment and sampling procedures, Potential risks and benefits, confidentiality.
ii. For vulnerable subjects (children, pregnant women, institutionalized subjects), state how subjects protection will be ensured.
iii. Provide Consent Form with simple and clear language.

Timelines/work schedule
This may be in the form of a Gantt chart (to show different activities versus time frames for expected completion).

Personnel of the study team
Role of each member (Not applicable for students)

Budget & logistics
i. To be detailed even if no external funding is required.
ii. For funds managed by KBTH Administration, charges will apply.

References
Use either Harvard or Vancouver Style. Must choose one and must be consistent

Appendix
i. Questionnaire (if any)
ii. Any other attachments
iii. CV for the PI (maximum 2 pages)