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.
Topics:
Agreements/Contracts | Protocols | Laboratory/Pharmacy | Study Set-up | Site Selection
Community Engagement Tools | Social Science Study Tools
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:
Downloads
|
Protocols
|
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 and data capture forms for Zika studies 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 Zika Research Tools, including a set of maternal and neonatal CRFs that aim to capture core data related to ZIKV infection and a potential link to Microcephaly. All Zika-related tools, alongside information for clinicians, researchers, and other interested parties in the Zika affected countries are made available on a website on the Global Health Network that is maintained by ISARIC's Coordinating Centre: www.zikainfection.org CONSISE has developed 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. All standardized protocols have been designed to maximize the likelihood that epidemiological, clinical and exposure data and biological samples are systematically collected and shared rapidly in a format that can be easily aggregated, tabulated and analyzed across many different settings globally. Useful Links |
Laboratory/Pharmacy
|
The templates here include the selection criteria when choosing a laboratory, packaging and labelling templates, for example, of an Investigational Medicinal Product. Downloads
|
Study Set-up
|
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. Links |
Site Selection
|
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. Downloads
|
Community Engagement Tools
|
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. Links
|
Social Science Study Tools
|
Social science as a field of study examines society and how people interact and develop as a culture. Links |