Methodology
The methodology section is the most important part of the protocol. It should include detailed 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. If multiple sites are engaged in a specified protocol, methodology should be standardized and clearly defined.
Interventions should be described in detail, including a description of the drug/device/vaccine that is being tested. Interventions could also be in the realm of social sciences for example providing training or information to groups of individuals.
Procedures could be biomedical (collection of blood or sputum samples to develop a diagnostic test), or in the realm of social sciences (doing a questionnaire survey, carrying out a focus group discussion as part of formative research, observation of the participant's environment, etc.).
Standardized and/or documented procedures/techniques should be described and bibliographic references, if not provided earlier should be provided. Instruments which are to be used to collect information (questionnaires, FGD guides, observation recording form, case report forms etc.) must also be provided.
In the case of a randomized controlled trial additional information on the process of randomization and blinding, description of stopping rules for individuals, for part of the study or entire study, the procedures and conditions for breaking the codes etc. should also be described.
A graphic outline of the study design and procedures using a flow diagram must be provided. This should include the timing of assessments.
Safety Considerations
The safety of research participants is foremost. Safety aspects of the research should always be kept in mind and information provided in the protocol on how the safety of research participants will be ensured. This can include procedures for recording and reporting adverse events and their follow-up, for example. It is useful to remember that even administering a research questionnaire can have adverse effects on individuals.
Follow-Up
The research protocol must give a clear indication of what follow up will be provided to the research participants and for how long. This may include a follow u, especially for adverse events, even after data collection for the research study is completed.
Data Management and Statistical Analysis
The protocol should provide information on how the data will be managed, including data handling and coding for computer analysis, monitoring and verification. The statistical methods proposed to be used for the analysis of data should be clearly outlined, including reasons for the sample size selected, power of the study, level of significance to be used, procedures for accounting for any missing or spurious data etc. For projects involving qualitative approaches, specify in sufficient detail how the data will be analysed.
Quality Assurance
The protocol should describe the quality control and quality assurance system for the conduct of the study, including GCP, follow up by clinical monitors, DSMB, data management etc.
Expected Outcomes of the Study
The protocol should indicate how the study will contribute to advancement of knowledge, how the results will be utilized, not only in publications but also how they will likely affect health care, health systems, or health policies.
Dissemination of Results and Publication Policy
The protocol should specify not only dissemination of results in the scientific media, but also to the community and/ or the participants, and consider dissemination to the policy makers where relevant. Publication policy should be clearly discussed- for example who will take the lead in publication and who will be acknowledged in publications, etc.
Duration of the Project
The protocol should specify the time that each phase of the project is likely to take, along with a detailed month by month timeline for each activity to be undertaken.
Problems Anticipated
This section should discuss the difficulties that the investigators anticipate in successfully completing their projects within the time frame stipulated and the funding requested. It should also offer possible solutions to deal with these difficulties.
Project Management
This section should describe the role and responsibility of each member of the team
Ethics
The protocol should have a description of ethical considerations relating to the study. This should not be limited to providing information on how or from whom the ethics approval will be taken, but this section should document the issues that are likely to raise ethical concerns. It should also describe how the investigator(s) plan to obtain informed consent from the research participants (the informed consent process).
Informed Consent Forms
The approved version of the protocol must have copies of informed consent forms (ICF), both in English and the local language in which they are going to be administered. However translations may be carried out after the English language ICF(s) have been approved by the ERC. If the research involves more than one group of individuals, for example healthcare users and healthcare providers, a separate specifically tailored informed consent form must be included for each group. This ensures that each group of participants will get the information they need to make an informed decision. For the same reason, each new intervention also requires a separate informed consent form.
Budget
The budget section should contain a detailed item-wise breakdown of the funds requested for, along with a justification for each item.
Other support for the Project
This section should provide information about the funding received or anticipated for this project from other funding organizations.
Collaboration with other scientists or research institutions
Links to other projects
Curriculum Vitae of investigators
The CV of the Principal investigator and each co-investigators should be provided. In general each CV should not be more than one page, unless a complete CV is specifically requested for.
Other research activities of the investigators
The Principal investigator should list all current research projects that he/she is involved in, the source of funding of those projects, the duration of those projects and the percentage of time spent on each.
Financing and Insurance
Financing and insurance if not addressed in a separate agreement, and where relevant should be described.
Maaflah sebab dua bab ini banyak bahasa inggeris. bukan apa, penerangannya tak boleh diubah kepada bahasa melayu. mohon bertabah. terima kasih.
ANDA SEDANG MEMBACA
BIDADARI DUNIA
Romansaبِسْــــــــــــــــــمِ اللهِ الرَّحْمَنِ الرَّحِيْمِ Dijamin tiada babak jahat, orang ketiga dan sebagainya. Masih janji yang sama dan kekal dengan janji yang sama. Ada kalanya dunia nyata menyakitkan dan dunia buku memberi seribu satu kemanisan...
