1 | Title |
2 |
Principal Investigators, Co-Investigators and Supervisors where applicable -Their addresses and signatures should be included -Role of investigators/supervisors as applicable -The committee may require their curriculum vitae |
3 | Any collaborating institution(s) |
4 |
Funding agency where applicable -The committee may require their curriculum vitae |
5 | List of abbreviations and acronyms |
6 | Operational definitions |
7 | Table of contents |
8 | Structured summary (Approximately 200-300 words) |
9 | Introduction/background |
10 |
Literature review including conceptual/theoretical framework |
11 | Rationale/ Study justification |
12 |
Study questions, hypothesis where applicable |
13 |
Objectives/Aims: a. Broad objective(s)/overall goals b. Specific objectives c. Secondary objectives if applicable |
14 |
Methodology: a. Study design b. Study area description -Specific study site c. Study population -Population characteristics -Definition of cases/controls if applicable -Inclusion/exclusion criteria d. Sample size determination and formula/computer programme used (assumptions and reference) e. Sampling procedure/screening/selection of study participants f. Recruitment and consenting procedures g. Variables – dependent, independent, confounders where applicable h. Data collection procedures (qualitative and quantitative data, field data collection instruments, laboratory procedures etc) i. Materials – equipment, supplies etc j. Training procedures where applicable k. Quality assurance procedures |
15 | Ethical consideration-briefly explain the ethical issues that may be associated with the study and strategies to address them |
16 | Data management (data entry, cleaning, storage, security and quality assurance, statistical analysis plans etc.) |
17 | Study results dissemination plan |
18 | Study limitations and how to minimize them |
19 | Study timeline/time frame |
20 | Study closure plan and procedure |
21 |
References - Use internationally accepted format e.g. Vancouver, Harvard, American Psychological Association (APA) etc. must maintain format consistency |
22 |
Budget and budget justification; -Consider coverage of such areas as Personnel, Salaries and Salary disbursements, Training costs, Participants service costs, Supplies and equipment, Animal acquisition where applicable, Travel and accommodation, Transport – vehicles – repair, fuel, Operating expenses – postage, report writing etc., Consultancy if applicable, Dissemination, Miscellaneous, Contingency (%) |
23 |
A. Informed Consent/ Assent Explanation and Consent Form
(Click for the consent explanation template) II) Consent form to include investigators and participant statement with signature page; |
B. Study instruments/tools | |
C. Curriculum vitae where applicable | |
D. Reference procedures/ brochures etc. where applicable | |
E. Maps where applicable | |
F. Special information e.g. educational/publicity materials | |
G. Any other relevant information according to the study |
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More information to researchers 1. Severe Adverse Events (SAE) should be reported to the KNH-UoN ERC within 72 hours as per the approved format. (Click for the SAEs form) |
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