Research protocol
Protocol Format for research protocol
- Project summary (Link CHS-IRB executive summary format)
- General information
- Protocol title, protocol version, and date.
- Type of protocol (clinical trial[phase], case control, laboratory based etc.)
- Name and address of the sponsor/funder.
- Name and title of the investigator(s) who is (are) responsible for conducting the research, and the address and telephone number(s) of the research site(s), including responsibilities of each.
- Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s) and/or institutions involved in the research
- Rationale and background information
A description of the research question to be addressed in the current proposal, and puts the proposal in context and should answer the question of why and what: why the research needs to be done and what will be its relevance. Description of most relevant and up to date studies published on the subject with appropriate literature review should be included.
- Study goals and objectives
The general objective and specific objectives of the study
- Research Methods : Study design (type of study), Study site/s, description of facilities at sites, the research population or the sampling frame, and who can take part (e.g. inclusion and exclusion criteria, withdrawal criteria etc.), and the expected duration of the studydetailed information on the interventions to be made, procedures to be used, measurements to be taken, observations to be made, laboratory investigations to be done etc., Instruments which are to be used to collect information (questionnaires, FGD guides, observation recording form, case report forms etc.) must also be provided.A graphic outline of the study design and procedures using a flow diagram must be provided. This should include the timing of assessments. The following should also be included:-
- Recruitment procedure
- Sample size determination
- Safety consideration
- Follow up
- Data management and statistical analysis
- Quality assurance
- Expected outcomes of the study
- Dissemination of results and publication policy
- Ethical considerations
- Project management
- Budget and time plan
- Reference of literature (used in preceding sections)
- Annexes (participant information sheet, consent form, data collection tool, MTA [where applicable], approval from other Institutions [where applicable], CV of all investigators and any associated documents as applicable)
