COVID Research Uxbridge University is currently within the forefront of attempts to eradicate COVID-19. The university has developed one in all the leading covid vaccines currently approved to be used in the UK and is within the process of getting approval for its use in an exceedingly number of other countries. As a results of its successes, the university has become a significant hub for COVID studies and is collaborating with variety of national and international intitutions in its research. It is currently active within the development of other vaccines which are designed to counter some of the variants that have appeared within the UK et al within the world. Work is currently ongoing on the event of vaccines for 3 different variants, but researchers are cognizant that they have to be prepared for several more within the next few years. Development of every vaccine involves strict management, so a project manager (usually a senior researcher at the university) is assigned to line up and monitor each vaccine development project. This involves establishing timelines for the assorted stages of its development, eg deadlines for testing, approval etc. Unfortunately these deadlines are not always met for example, phases of testing may overrun, leading to start dates of subsequent test phases being delayed. At the tip of the event the Research Director must understand how the particular development schedule compared to the proposed schedule founded at the beginning of the project. it's hoped that having information on any slippages will allow more realistic estimates for future projects. Clinical Trials Extensive and rigorous testing is required to make sure that a vaccine is safe before it can be introduced to be used. An experimental vaccine is first tested in animals to guage its safety and potential to stop disease. It then undergoes rigorous testing in human clinical trials, in three phases: Phase 1: the vaccine is given to atiny low number of volunteers to assess its safety, confirm it generates an reaction, and determine the right dosage Phase 2: In phase 2, the vaccine is sometimes given to many volunteers by medical staff in an exceedingly restricted number of medical centres, and that they are then closely monitored for any side effects. Data is collected on any side effects and disease outcomes. An equal number of volunteers will get a placebo which will be used for comparison. the information collected during this phase isn't in large enough numbers to have a transparent picture of the effect of the vaccine on the disease but it does allow some comparisons to be made and conclusions drawn about the vaccine. Phase 3: Here the vaccine is given to thousands of volunteers a number of whom receive the vaccine, and a few of whom don't, similar to in phase 2 trials. Data from both groups is carefully compared to determine if the vaccine is safe and effective against the COVID variant that's being tested. Once the results of clinical trials are available, the united kingdom regulator are notified and a number of steps are then administered by the regulator, including reviews of efficacy, safety and manufacturing for regulatory and public health policy approvals, before the vaccine is given formal approval for being introduced into a national immunization programme. The university currently maintains a register of volunteers who have agreed to form their data available for research and to require part in trials. Basic information about each volunteer is recorded, eg name, contact details, DOB, gender and general health. Each trial has to have a proportion of healthy and at risk participants. At risk volunteers are people who have one or more underlying health problems eg they'll have diabetes, cardiopathy, asthma, cancer etc. Each of those illnesses are assigned a risk rating (eg diabetes may be given a risk rating of two, cardiovascular disease 3, asthma 2 etc) and this allows researchers to calculate an overall risk for every volunteer, to point which volunteers are most in danger and might require more intense monitoring in a very trial. When a specific vaccine trial is planned (whether Phase 1, Phase 2 or Phase 3) the project manager will put together a Clinical Trial Specification which specifies the researchers who are involved within the trial, the proposed start and end date of the trial and the total number and kind of participants that are required for the trial, based on: Gender (ie what percentage participants of every gender are required (this is sometimes equal numbers, but can vary) Age (showing what number participants from each people are required) The trial Specification has to be formally authorised by the director of research (and the authorisation date recorded), after which the researchers within the team will need to assign volunteers thereto, supported the specification provided. Once the trial has started, the date the vaccine (or placebo) was administered to every volunteer has to be recorded, together with the placement at which it had been administered and the dosage of vaccine provided. Then, each volunteer are going to be contacted after 14 days and after 28 days of receiving the vaccine/placebo by a researcher to test for any side effects of the vaccine (and to determine if anyone has contracted COVID). Each volunteer is allocated to 1 researcher and may also contact that researcher at any time if they're experiencing any problems/side effects or are feeling anxious about any aspect of the trial. This contact must be recorded (ie the date of contact, what the difficulty was, etc). Human Challenge Trials The University is additionally involved in human challenge trials, during which participants are intentionally infected with alittle dose of a COVID organism and monitored intensely. These individuals are within the 18-30 cohort category and are screened intensively before being registered to make sure they're 100% healthy. A separate spreadsheet is employed to record these individuals. Challenge trials involve significant time, inconvenience and risk, requiring participants to spend between 3 and 6 weeks in quarantine for twenty-four hours on a daily basis during a high-security facility. During this point they only receive contact from researchers collecting necessary data and checks. Following the quarantine period they're going to still be monitored regularly for several months. Because of the extent of commitment required from participants in challenge trials, they are bought their services (unlike other trial participants), typically at a rate of around 4500 per participant. However, the quantity is paid in instalments, to encourage participants to still engage within the lengthy monitoring process. within the past such payments were handled by the universitys finance department, but this was slow and involved an excessive amount of paperwork, so it's been agreed that the research department will manage these payments. There must be a more reliable system to point out which participants have received which instalments and the way much is left to pay. Research Publications Researchers also are involved in publishing research supported vaccine development as papers in academic journals. they will either publish a paper on their own, or with other co-researchers. Details of all publications, date of publication, their authors, and the journal the paper was published in have to be recorded. The supervisor is interested in ensuring there's a high level of publication activity from each researcher and would really like to possess a straightforward means of auditing this from time to time. Unfortunately (and incredibly) the department has been using miscellaneous spreadsheets and other circumstantial systems to record various aspects of their vaccine development processes and participant details, but these spreadsheets have now become too unweildy and impractical and therefore the universitys director of research has turned to your team to style a centralised database which will cater for all their needs. The director of research would really like your team to place together an ER diagram and associated documentation for a database which is able to provide the flexibility to retrieve relevant information on COVID development plans, clinical/Challenge trial processes, participants and research activities (as outlined within the description above) which it's hoped will improve the time taken to come up with relevant information and permit the Project Manager, Researchers and other interested parties simpler control over vaccine development processes.

please make an ER diagram on it

its Urgently needed