The following are FAQs for clinical research staff who use TOPS in relation to how the system should be updated.
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Should I ask the volunteer for their National Insurance (NI) number or for their passport number?
What should I do if a volunteer holds more than 1 non-UK passport?
What should I do if a volunteer has both a UK passport and a non-UK passport?
Can a volunteer be registered using a National Identity Card or Passport Card?
What should I do if I am unsure whether a volunteer has been dosed or not?
What information do I enter on TOPS if the volunteer was in the placebo arm?
How long is the data for each volunteer viewable to other units?
Should I ask the volunteer for their National Insurance (NI) number or for their passport number?
If the volunteer is a UK national, you should request evidence of their NI number. It is important to check that the name provided on the NI document corresponds with the name provided on their photo ID documents. If the volunteer is a foreign national, you should request evidence of their passport number.
When using the passport number to register a foreign national in TOPS, the unit should check whether the passport has been issued in the last year. It is good practice to check because the passport number changes when an individual’s passport is renewed or updated (e.g., if a volunteer has changed their name) and so you should ask for the previous passport number (if available) to check TOPS as well.
It is the responsibility of the unit to ensure that you have confirmed whether a volunteer may be withholding other valid forms of ID (such as a previous passport) that could be used in TOPS in order to reduce the risk of over-volunteering.
What should I do if a volunteer holds more than one non-UK passport?
You should make a separate registration entry for each passport number.
What should I do if a volunteer has both a UK passport and a non-UK passport?
You should register the passport number and country of origin of the non-UK passport. If the volunteer has a NI number, this should be entered too.
Can a volunteer be registered using a National Identity Card or Passport Card?
No. An actual passport rather than a passport card/National Identity Card is required for registration on TOPS in order to be able to detect over-volunteering. Volunteers that have passport cards/National Identity cards can also have an actual passport, and the passport number will be different to the number in the passport card. TOPS would not be able to detect over-volunteering if passport cards are used as well as passports therefore, units should continue to use passports only to register non-UK citizens on TOPS.
What should I do if I am unsure whether a volunteer has been dosed or not?
If a volunteer is registered with another unit, but the outcome of the registration (last dose date or ‘Not dosed’) has not been completed on TOPS, you should get in touch with the contact person at that unit. If you are in any doubt, always contact the other unit before admitting a volunteer onto a study. The first unit should then ensure that the relevant record is updated on TOPS.
If TOPS shows that a volunteer has received a dose of the study medicine in a previous study, how do I know if it is safe for them to participate in a new study?
The unit should discuss the previous engagement with the volunteer to determine if it is safe for the person to engage onto a new clinical trial/study, this discussion should consider the study medicine that the volunteer may or may not have taken on the previous clinical trial/study and the ‘wash out’ period for the study medicine after the last dose date that has been entered into TOPs.
This information should be detailed in the study participant materials for the previous clinical trial/study, but this may not be available from the volunteer, therefore it is always recommended that contact the previous unit is made to discuss any queries or concerns there may be in terms of the period from the last dose date and the study medicine ‘wash out’ period, and the commencement onto a new clinical trial.
I have registered a volunteer but the volunteer is no longer going to take part in the study. What should I do?
On the ‘edit last dose’ screen, you should select ‘Never dosed’.
Our unit has identified a volunteer who appears to over-volunteer deliberately. How should we handle the situation?
You are not obliged to do anything. Other units will be able to see from the volunteer’s registration history that he or she has taken part in too many studies. You may wish to discuss the issue with the volunteer, as his or her health may be at risk.
One of our recent studies evaluated a procedure, not a drug. Therefore, the volunteers did not take any study medication, but they had to give some blood. How do I explain the situation?
If the volunteer gave a lot of blood (more than 100 mL) during the study, you should enter the date of the last blood sample as the ‘last dose date’. That will allow the volunteer to recover before giving more blood during another study. If the volunteer gave a small amount of blood (100 mL or less), and you feel that it would be safe for them to participate in another study soon, you should press ‘Never dosed’ to indicate that the volunteer received no study medication. If you are contacted by a different unit, you can inform them that the volunteer gave a blood sample but did not receive any study medicine.
What information do I enter on TOPS if the volunteer was in the placebo arm?
In most cases investigators do not know whether the volunteer has received the placebo or the study medicine. However, even if you do have confirmation that the volunteer received the placebo, the TOPS record should still be updated to state the date of the last dose in order that other units can see that the volunteer has participated in a study.
What is the IRAS project ID?
The IRAS project ID is the first set of six digits found in the submission code on the IRAS application form. The IRAS project ID for the study can also be found on any validation or decision letters issued by the Health Research Authority or Research Ethics Service.
When entering ‘Never Dosed’, why am I being asked to specify if the volunteer was already taking part in another clinical trial?
This is to identify how frequently TOPS is an effective method of preventing over- volunteering.
How long is the data for each volunteer viewable to other units?
‘Last dose’ date entered = If a volunteer receives a dose of the study medicine, the volunteers’ data will remain viewable to other units until the end of the long term follow-up date. If a follow-up date has not been entered, the record will be viewable for two years in order that other units can contact the unit in which the volunteer received a dose of the study medicine if more information is required. If the study involved a Monoclonal Antibody (mAb or MoAb), radiolabelled product or biological product the records will remain reviewable to other units permanently.
‘Never dosed’ entered = The volunteers’ data will not be viewable to other units once the volunteers record has been updated to state ‘Never dosed’.
Volunteer registered but no last dose date or ‘never dosed’ specified = If the volunteers’ record is not updated to state that they received a dose or to state that they were never dosed, the data will be viewable to other units for two years from the registration date.
Please Note the monoclonal antibody (MoAb) check box was replaced with two separate options ‘biological product’ or ‘radiolabelled product’ in November 2017.
The MoAb column still appears in volunteer records so that historic entries for volunteers who received monoclonal antibody prior to November 2017 can still be viewed in TOPS.
How long is the data for each volunteer held in TOPS?
Data entered on TOPS is only retained for the minimum period required and this is determined based on whether the volunteer received a dose of the study medicine or not.
If the volunteer ever received a dose of the study medicine, this data will be retained in TOPS. If the volunteer was never dosed the data would be held for two years after the volunteer was ‘never dosed’.