I need help for creating ERD Diagram for the following scenario: Uxbridge Universitys COVID Vaccine Development TeamCOVID ResearchUxbridge University is currently in the forefront of attempts to eradicate COVID-19. The university has developed one of the leading covid vaccines currently approvedfor use in the UK and is in the process of getting approvalfor its use in a number of other countries.

As a result of its successes, the university has become a majorhub for COVIDstudiesand is collaborating with a number of national and international intitutionsin its research.

It is currently active in the developmentof other vaccines which are designed to counter some of the variants that have appeared in the UK and elsewherein the world. Work is currently ongoingon the development of vaccines for 3different variants, but researchers arewell aware that theyneed to be prepared for many more in the next few years.

Development of eachvaccine involvesstrict management,soa project manager (usually a senior researcher at the university) is assigned to set up andmonitor each vaccine developmentproject. This involves establishing timelines for the various stages of its development, egdeadlines for testing, approval etc. Unfortunately these deadlines are not always met for example,phases of testing may overrun, resulting instart dates of subsequent test phases being delayed.At the end of the development the Research Director needs to know how the actual development schedule compared to the proposed schedule set up at the start of the project. It is hoped that having information on anyslippages will allow more realistic estimates for future projects.

Clinical Trials

Extensive and rigorous testing is required to ensure that a vaccine is safe before it can be introduced for use. An experimental vaccine is first tested in animals to evaluate its safety and potential to prevent disease. It then undergoes rigorous testing in human clinical trials, in three phases:

Phase 1: the vaccine is given to a small number of volunteers to assess its safety, confirm it generates an immune response, and determine the correct dosage

Phase 2: In phase 2, the vaccine is usually given hundreds of volunteers, who are closely monitored for any side effects. Data is collected on any side effects and disease outcomes. An equal number of volunteers will getaplacebo that will be used for comparison. The data collected in this phase is not in large enough numbers to have a clear 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 some of whom receive the vaccine, and some of whom do not, just like in phase 2trials. Data from both groups is carefully compared to see if the vaccine is safe and effective against the COVID variant that is being tested.

Once the results of clinical trials are available,the UK regulator will be notified and a number of steps are then carried out 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 make their data available for research and to take part in trials. Basic information about each volunteer is recorded, eg name, contact details, DOB, genderand general health.Each trial needs to have a proportion of healthy and at risk participants. At risk volunteers are those who have one or more underlying health problems eg they may have diabetes, heart disease, asthma, cancer etc. Each of these illnesses are assigned a risk rating (eg diabetes might be given a risk rating of 2, heart disease 3, asthma 2 etc)and this allowsresearchers to calculate an overall riskfor each volunteer, to indicatewhichvolunteersare most at riskand might require more intense monitoringin a trial.

When a particular vaccinetrial is planned (whether Phase 1, Phase 2 or Phase 3)the project manager will put together aClinical Trial Specification which specifiestheresearcherswho will be involvedin the trial, the proposed start and end date of the trialand the total number and typeofparticipants that are requiredfor the trial, based on:

Gender(ie how many participants of each gender arerequired (this is usually equal numbers, but can vary)

Age (showing how many participants from each age group are required)

The Clinical Trial Specification needs to be formally authorised by the Research Director(and the authorisation date recorded), after which the researchers in the team will need to assign volunteers to it, based on the specification provided.

Once the trial has started, the date the vaccine (or placebo) was administered to each volunteer needs to be recorded, along with the location at which it was administeredand thedosageof vaccine provided.

Then, each volunteer will be contacted after 14 days and after 28 days of receiving the vaccine/placebo by a researcher to check for any side effects of the vaccine(and to see if anyone has contracted COVID). Each volunteer is allocated to one researcher and may also contact that researcher at any time if they are experiencing any problems/side effectsor are feeling anxious about any aspect of the trial. This contact must be recorded(ie the dateof contact, what the issue was, etc).

Human Challenge Trials

The University is also involved in human challenge trials, in which participants are intentionally infected with a small dose of a COVID organism and monitored intensely. These individuals are inthe 18-30 age group category and have been screened intensively prior to being registered to ensure they are 100% healthy. A separate spreadsheet is used to record these individuals. Challenge trials involve significant time, inconvenience and risk, requiring participants to spend between 3 and 6 weeks in quarantine for 24 hours a day in a high-security facility. During this time they only receive contact from researchers collecting necessary data and checks. Following the quarantine period they will continue to be monitored regularly for many months.

Because of the level of commitment required from participants in challenge trials, they are paid for their services (unlike other clinical trial participants), typically at a rate of around 4500 per participant. However, the amount is paid in instalments, to encourage participants to continue to engage in the lengthy monitoring process. In the past such payments were handled by the universitys finance department, but this was slow and involved too much paperwork, so it has been agreed that the research department will manage these payments. There needs to be a more reliable system to show which participants have received which instalments and how much is left to pay.

I'd really appreciate it if you can do the ERD Diagram for this scenario assessment I must do for my Information Systems & Databases Module. Thank you!