Please insert your details below and select the correct answers.
Once complete send to Mark Ferguson, address at end of form.
Name:______________________________
Department: _________________________
Email Address: _______________________
Telephone Number:____________________
1. Once a Consent Form has been signed, copies should go to:
a) the Investigator Site File, the participant, the Case Report Form.
b) the Investigator Site File, the participant, the medical notes.
c) the participant, the Case Report Form, the medical notes.
d) the ethics committee, the Case Report Form, the medical notes.
e) the participant, the ethics committee, the Investigator Site File.
2. Which of the following includes groups of people who are not vulnerable subjects?
a) Prisoners, children, the unconscious, people with learning difficulties.
b) Children, the unconscious, healthy volunteers, people with learning difficulties.
c) People with learning difficulties, medical students, prisoners, the elderly.
d) Prisoners, children, the unconscious, disadvantaged communities.
e) People with learning difficulties, the unconscious, prisoners, the elderly.
3. How much time should be given for a potential participant to read the information sheet?

a) it depends on the type of drug being used, but as much time as possible.
b) it depends on the type of drug being used, at least 24 hours.
c) as much time as is needed, but at least 24 hours.
d) it depends on what is written in the protocol, but as much time as is needed.
e) it depends on the type of trial, but at least 48 hours.
4. If there is no intended benefit to the clinical subjects in a trial how should this be addressed in the information for the subjects?
a) the section on reasonably expected benefits should be omitted.
b) the subject should be paid instead and the amount outlined in the informed consent.
c) the subject should be made aware that there is no intended benefit.
d) it is sufficient for the person taking consent to just tell the subject there is no intended benefit.
e) the clinical trial should not be conducted if there is no benefit for subjects.
5. Responsibility for taking consent can be delegated to the following:
a) any doctor working in the department.
b) any nurse working on the trial.
c) anyone who has the knowledge and training to qualify them to do so.
d) the pharmacist.
e) only to someone medically qualified.
6. The hierarchy of who can consent for a minor in clinical research:
a) the parent then professional legal representative then personal legal representative
b) the parent, then personal legal representative then professional legal representative
c) a person with parental responsibility then personal legal representative then professional legal representative
d) a professional legal representative then the parent then personal legal representative.
e) Answers b) and c)

7. Before signing the Consent Form the person taking consent should:
a) ensure that all the data are correct.
b) ensure the potential participant has understood how to fill out the diary.
c) ensure that the potential participant will not withdraw from the study.
d) ensure that the potential participant understands what the risks are.
e) ensure that all the blood results are within normal range.
8. In emergency situations where prior consent of the subject or their legal representative is not possible what does GCP say should happen?
a) enrolment of the subject should require measures outlined in the protocol and approved by the ethics committee. b) subject or legal representative to be informed as soon as possible. c) consent to continue should be sought as soon as possible. d) answers a) & c) above e) all of the above
Send completed forms to:
Mark Ferguson
TAyside medical Science Centre (TASC)
Ninewells Hospital & Medical School
TASC Research & Development Office
Residency Block, Level 3
George Pirie Way
Dundee, United Kingdom
DD1 9SY
Or Email: mark.ferguson@nhs.net