Platform Randomised Trial of Treatments in the Community for Epidemic and
Pandemic Illnesses - PRINCIPLE
REC Number: 20/SC/058 IRAS Number: 281958 EudraCT Number: 2020-001209-22
Chief Investigator: Professor Christopher Butler Participant ID:
CONSENT FORM
Thank you for completing the screening questionnaire, you have passed the screening stage for
the trial.
Please read the Participant Information Sheet if you haven't already done so, and if you are willing
to participate please select ‘Yes’, TYPE your FIRST and LAST names below and then click Submit
If you agree, please select ‘Yes’ to confirm that you have read and understood the following:
YES NO
I confirm I have read and understood the information sheet version number ____-
1 ________dated __ __ / __ __ __ / __ __ __ __ for the above study. I have had the
opportunity to ask questions and had these answered satisfactorily.
I understand my participation is voluntary and that I am free to withdraw at any time,
2
without giving any reason, and without my medical care or legal rights being affected.
I understand that if I chose to withdraw data already collected will continue to be used
and I or my GP may be contacted if there are further questions regarding side effects
3
from trial medications.
I understand that I will be randomised to receive either: standard care plus a trial
4
treatment or standard care, and that I will not be able to choose which I will receive.
I understand that relevant sections of my GP and Hospital medical notes and data
collected during the study may be looked at by members of the research team and
individuals from University of Oxford, both during and for up to 10 years after the
5 scheduled follow-up period. It may also be reviewed by relevant people from regulatory
authorities and from the NHS Trust(s). I give permission for these individuals to have
access to my records
I understand that members of the research team may view my Summary Care Record
(SCR) to check my medication, allergies, adverse reactions and additional information to
6
make sure that it is safe for me to take trial medication. I give permission for these
individuals to access my SCR for this purpose.
I consent to being contacted by the research team for the purposes of trial follow up (up
7 to 12 months) and I understand that this will require me to provide my contact details to
the research team.
I consent to my GP and/or Care Home being informed of my participation within the
8 study and I understand that the trial team may contact my GP about my ongoing
participation in the trial
9 I agree to take part in the study
10 I understand that the information collected about me may be shared in a form that
PRINCIPLE Consent Form Version 5.0 04-Nov-2021 EudraCT: 2020-001209-22
cannot identify me with commercial companies to support the licensing of trial
treatments, within the UK and abroad.
For women of child-bearing potential only: I agree to take the urine pregnancy test
11
provided on Day 1 of the trial and confirm my test result to the trial team
ADDITIONAL (optional, not required for study participation) YES NO
I agree to provide the research team with the contact details of my Trial Partner. I
1
confirm my Trial partner is aware of their role and willing to answer questions.
I am happy to be contacted by the research team to be invited to a telephone interview at
the end of the study.
2
(Taking part in the interview is optional and will not affect your study participation. If you
agree to be contacted, the research team will contact you with details of the interview in
approximately 28 days. You can then decide whether you want to take part or not.)
If you are the participant completing the consent form, please provide your
signature below
Participant Signature:
First Name: _______________ Last Name: __________________
Date: __ __ / __ __ / __ __ __ __
If the participant has provided verbal consent, but they are unable to complete
the consent form due to lack of online access, too unwell, too frail or consent is
completed via the telephone (the participant must have capacity), please provide:
1. Name of the participant
First Name: _______________ Last Name: __________________
Date: __ __ / __ __ / __ __ __ __
2. Signature of person completing the form
First Name: _______________ Last Name: __________________
Role: Study Partner/Trial Team Member/Health Care Professional
Date: __ __ / __ __ / __ __ __ __
If participant lacks capacity to give consent:
I have read the information (or had it read to me) and had an opportunity to ask questions.
Participant:
Name: _____________________________ Date: __ __ / __ __ / __ __ __ __
PRINCIPLE Consent Form Version 5.0 04-Nov-2021 EudraCT: 2020-001209-22
I believe that if they were able to, the patient would wish to take part in this study.
…………………………………………… ……………………………………. ……../……../…………
PRINTED name of Legal Representative Signature Today’s date
……………………………………………
Relationship to participant
You will have the opportunity to print a copy of the consent form after submission. Please contact the study team if
you would like a copy sent to you
By submitting, I confirm that I am the person whose name is stated above.
If you have any questions about this or any other part of the study please contact the study team:
Tel: 0800 138 0880 Email principle@[Link]
PRINCIPLE Consent Form Version 5.0 04-Nov-2021 EudraCT: 2020-001209-22