Dear Clinical trial volunteer,
Parexel clinical trial unit (Harrow) COVID-19 Guidance July 2020
The health, safety and wellbeing of clinical trial volunteers, visitors and personnel is a priority for us whilst on our premises. Parexel has implemented processes to mitigate COVID-19 transmission risks for all our clinical trials.
Kindly observe the following COVID-19 precautions to support us towards our efforts in avoiding a spread of Covid19 infection.
Before attending the unit:
Please inform us in advance if any of the below applies to you:
We ask that you do not attend the unit if you are currently at a high risk of infection:
High risk is defined by the Parexel clinical unit (Harrow) as; -
- If in the last 2 weeks you have been unwell with flu symptoms such as fever (above 38◦C), dry cough, tiredness, aches and pains, severe headache, difficulty breathing, loss of sense of smell and taste, runny nose, sore throat or diarrhoea;
- If in the last 2 weeks, you have been in contact with any person who has since told you they may have COVID-19; or who at the time of your contact had ‘flu like’ symptoms as described above;
- If you have travelled from abroad in the last 2 weeks.
You may reschedule and visit the unit after the risk subsides. The Parexel team will work with you as required.
During your visit: (applicable to clinical trial screening and admission)
Prior to entry into the facility you will be asked to confirm that you are not high risk (as per the criteria above) and your temperature will be monitored.
If you consent to it, you will additionally be COVID-19 tested at Screening, Admission and at other intervals as determined by the medical team.
Masks will be provided to clinical trial participants for the duration of your stay and will be replaced when damaged. We request that you wear a mask in communal areas whilst on our premises or where social distancing of 6 feet / 2 metres is not possible. If not possible, remain side by side or back to back. Where face to face interaction is essential it should be limited to 15 minutes or less where possible.
Please continue to practice frequent hand hygiene whilst on our premises.
Clinical trial admission:
During the clinical trial admission, you may initially be placed in a ward with open bed spaces between you and other trial participants, but once we have your COVID-19 results returned, you may be moved into another dormitory or into another bed space. Static clear plastic curtains will separate your bed space from the next and your blue moveable bed curtains will additionally remain in place for your privacy.
Everyone is encouraged to please continue to practice frequent hand hygiene whilst at the unit. Handwashing is very important. You will also be expected to clean your area and certain high frequency used objects such as your static clear curtain, bed table and taps etc. before and after use.
Limit your footprint in the unit only to areas where you must be. It is important to limit exposure to yourself and to other people so please only remain in areas where you are needed to be. Avoid the recreation area. Time slots may be provided to you for entry into the recreation area and your meals may be offered at your bed side.
NHS Test and Trace
The NHS Test and Trace service has been developed to alert any close contacts of infected individuals, isolate those who may be infective and test those with symptoms of COVID-19. The NHS test and trace service will alert you if you have been in close contact with someone who has tested positive for coronavirus. The alert will usually come by text, email or phone call.
Close contact means:
Having face-to-face contact with someone (less than 1 meter away)
Spending more than 15 minutes within 2 meters of someone
Travelling in a car or other small vehicle with someone
If you are contacted by the NHS Test and Trace service at any time during the study, from signing informed consent document until final follow up visit, you must inform Parexel study doctor using the contact numbers in this consent form immediately. You must inform the study doctor what the outcome of this communication was, including any advice they provided to you. At any of your screening visit(s) you must also inform a study doctor of any contact with the NHS test and trace service that occurred during the 14 days prior to screening.
If you become unwell during your visit, kindly inform a member of staff immediately who will support you.
Parexel Harrow Management Team.