If you are thinking about starting a research project, the following guidance will show you how to plan clinical research. Good study planning is essential, to avoid any unnecessary delays or missing data down the line.
To translate the page, use the Google translate feature by clicking on the button below.
Study design & planning
Agreements/contracts
Many parties may be involved in the conduct and management of a research study and it is important that each party has a clear guide of what is expected of them.
Contracts and agreements should be in place prior to the start of the research project and periodic reviews should be considered in order to ensure that the documents are kept up to date and relevant.
The content of contracts and agreements should include: - The standards that are applicable (e.g. for Clinical Trials of Investigational Medicinal Product (CTIMPs) this would include the Clinical Trials Regulations) - The roles and responsibilities of the various parties - The procedures involved - The line of communication.
The protocol turns a research question into a study. The protocol should be practical and achieves the balance of ensuring that an accurate answer can be obtained in a safe, ethical and practicable way in the chosen clinical setting.
OPEN PROTOCOLS AND DATA CAPTURE: There are two important international networks who have created research tools such as open protocols with the objective of speeding up progress and gather data that is standardised and ready, as far as possible, for sharing and amalgamating. These are ISARIC and CONSISE.
The ISARIC network have worked with ISARIC, PREPARE Europe, and other partners and have developed a number of Research Tools
CONSISE has drafted several standardized research protocols for influenza, MERS-CoV and Zika Virus (ZIKV). The standardized protocols have all been developed with large numbers of technical experts, including WHO and incorporate knowledge and experience learned from conducting epidemiologic studies all over the world.
The templates here include the selection criteria when choosing a laboratory, packaging and labelling templates e.g. of an Investigational Medicinal Product.
If you are thinking about starting a research project, the following guidance will show you how to plan clinical research. Good study planning is essential, to avoid any unnecessary delays or missing data down the line.
Careful selection and evaluation of investigator sites is critical for the successful completion of a trial within budget and to timelines. There are many factors which should be consider, some include: The interest in the research question; the experience and qualifications of the investigator; their committment in terms of time, etc.
Mistrust in research can impede communities from recognizing the social benefits of research. Public involvement in research refers to the public being involved in the research process so that the work (or elements of it) is done with or by the public and not “to”, “about” or “for” them.
Through this facility research sites can register and let would-be collaborators and sponsors know about them, their previous experience and what type of research they would like to take part in. In turn, research groups wishing to find other sites to collaborate with can post their research plans and explain what they are looking for in terms of disease prevalence perhaps, or was facilities a research site has.
These free, certificated and recognised courses are provided to give a general introduction to many of the key steps involved in setting up a study they include short topics such as Good Clinical Practice, Good Laboratory Practice and longer modular courses and cover many of the required steps such as setting the question, data management and community engagement.
The Process Map is a cross-cutting tool that guides the process of setting up a study and provides links to explanations about each component step and any tools, templates and training that exist on each step.
