If your question is not answered in the information below, you may also check the study website or contact the Drug Safety Research Unit (DSRU) at covidmonitor@dsru.org


Who's conducting this study?


Is the COVID-19 vaccine unsafe?


Is personal data handled securely?


I have forgotten my password.


How do I know when I can complete a questionnaire?


How many questionnaires do I get?


How do I opt out of this study?


I can no longer participate in this study, but I did get a symptom/side effect after my vaccination. What should I do?


Will I be kept informed of the research results?


As a healthcare professional, can I request further information?

1.Who's conducting this study?

The Drug Safety Research Unit (DSRU), based in Southampton, is carrying out the UK part of the COVID-19 vaccine monitor study. The DSRU has been making sure medicines used in the UK are safe for 40 years. We are an independent organisation and not a government agency or pharmaceutical company. The Covid vaccine monitor study forms part of a wider study being carried out by a network of organisations throughout Europe. The study is funded by European Medicines Agency (EMA).

2.Is the COVID-19 vaccine unsafe?

No, the approved vaccines are safe. The coronavirus (COVID-19) vaccines have been researched thoroughly before being given to the public. Only by being well researched may they be used. However, side effects after vaccination are always a possibility. The DSRU would like to monitor this information. By doing so we will learn more about possible side effects as quickly as possible.

3.Is personal data handled securely?

Yes. We will follow ethical and legal practice, and all information which is collected about you during the study will be kept strictly confidential. Your data will be entered electronically using a secure website. Only authorised members of DSRU staff will have access to any personal information that you provide. We will only share anonymised data with University Medical Centre Utrecht and our other European partners. Nobody will know that you have taken part in the study. Further information regarding data privacy and data protection rights can be found in the Privacy Notice available at: https://researchonline2-cvm.mendixcloud.com

4.I have forgotten my password.

The study team do not have access to your password. To reset your password, please use the ‘Forgotten password?’ option.

5.How do I know when I can complete a questionnaire?

You will receive an e-mail prompt from us when it is time to fill in a new questionnaire. By logging in to https://researchonline2-cvm.mendixcloud.com you can access the latest questionnaire and complete it immediately. Completing each questionnaire takes around 10 minutes.

6.How many questionnaires do I get?

After registration you will receive a total of 6 questionnaires to complete spread over a period of approx. 3 months. The first questionnaire is ready for you to complete immediately after registration. Seven days after you receive the vaccination, you will receive the second questionnaire.

To complete questionnaires online, please log into your account at https://researchonline2-cvm.mendixcloud.com and navigate to your questionnaires. This takes an average of 10 minutes per questionnaire.

7.How do I opt out of this study?

You are free to withdraw from the study at any time, without giving a reason, and this will not affect the standard of care you normally receive. We just ask that you please let us know that you no longer want to participate by sending an email to: covidmonitor@dsru.org

We will destroy your personal data that we have collected and will not contact you again. We may use any non-personal data collected so far.

8.I can no longer participate in this study, but I did get a symptom/side effect after my vaccination. What should I do?

Please contact your GP or pharmacist if you have any medical questions relating to side effects after receiving the COVID-19 vaccine. Further information can also be found on the NHS or Public Health England websites: www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus- vaccine/

www.gov.uk/government/publications/covid-19-vaccination-what-to-expect-after- vaccination/what-to-expect-after-your-covid-19-vaccination

Any suspected side effects to COVID-19 vaccines can also be reported directly to the Medicines and Healthcare products Regulatory Agency (MHRA) on the Coronavirus Yellow Card reporting site below. This is a government system which is used to monitor the safe and effective use of COVID-19 vaccines and treatments available in the UK.


9.Will I be kept informed of the research results?

We will present findings of this study to the UK medicines regulator (the Medicines and Healthcare products Regulatory Agency [MHRA]) and the European medicines regulator (European Medicines Agency [EMA]). Results of this study will be submitted for publication in medical/scientific journals and presented at scientific meetings and will be posted in the EU PAS publicly accessible database of results. A dashboard for monitoring of results during the study will also be made publicly available. All of these will be anonymous, which means that you will not be able to be identified from them.

10.As a healthcare professional, can I request further information?

Yes, you can request further information about this study by contacting the DSRU at covidmonitor@dsru.org