The Protocol submitted to the Committee should be in the following sections:
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)
ii. General Aim
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.
What is expected to be achieved? Proposal must typically have one or two broad aim (s).
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).
Limit of 3 pages for literature review
Methodology (limit 5 pages for methodology)
Human studies- could be retrospective (case-control), prospective (cohort, clinical trial, case-control) or cross-sectional and others as appropriate
Describe site briefly including facilities available
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.
ii. Quality control (pre-testing, supervision, training) measures.
iii. Data security and confidentiality
i. Descriptive statistics (frequency, central tendencies, associations)
ii. Inferential statistics (test of means, correlation coefficient, etc)
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
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.
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.
Use either Harvard or Vancouver Style. Must choose one and must be consistent
i. Questionnaire (if any)
ii. Any other attachments
iii. CV for the PI (maximum 2 pages)