prednos trials: study procedures and case report forms...prednos 2 randomisation procedure...
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PREDNOS Trials:
Study Procedures
and Case Report
Forms
Charmaine Meek
PREDNOS Studies Annual Investigator Meeting, 19th May 2014
PREDNOS 2
Patient Enrolment Procedure
Screen existing clinic lists for potential patients using inclusion/ exclusion
criteria
Note all patients screened on Subject Screening Log
Letter to Accompany Information Sheets and Information Sheets to be
mailed to parents/ potential participants 1-2 weeks prior to next clinic
appointment
At the clinic appointment, a member of the PREDNOS 2 team will
discuss study in detail and answer any questions
If the parent/ participant agrees to participate in the study, written
informed consent should be taken
Any participant randomised should be documented on the Subject
Recruitment and Identification Log
PREDNOS 2
Consent Form Completion
Please ensure the following when completing the Parent/ Participant Consent Form:
The current version of consent form is used (V1.2 for both consent forms, V1.0
for the assent form)
Each point on the consent form is initialled by the parent/ participant
If consent has not been provided for blood samples to be taken, this point should
be left blank on the form
The parent/ participant signs the consent form and completes the correct date
(date of informed consent)
The consent form is witnessed the day it is completed by the parent/ participant
The details of the parent providing written consent matches the details provided
on the prescription form
The trial number is completed following randomisation, prior to faxing the
document to BCH Pharmacy
PREDNOS 2
Randomisation Procedure Randomisation should occur on the day of consent and baseline assessment
Fully complete the current Randomisation Form (V1.2) prior to randomisation
Points to note when completing the form:
– All information must be completed
– The last two relapses reported must have occurred within 12 months of the
date of randomisation
– The patient’s current dose of prednisolone on the day of randomisation
cannot be more than 15mg/m2 on alternate days
– When documenting the group the patient belongs to, this information needs
to match the current dose of prednisolone reported
To randomise:
– Telephone: 0800 953 0274 9am-5pm, Mon-Fri
– Online: https://www.trials.bham.ac.uk/PREDNOS2
PREDNOS 2
Online Randomisation
If randomising online, once logged in select the ‘Patients’ tab and go to ‘Enter new patient’.
PREDNOS 2
Online Randomisation
Following selection of randomising site and clinician, this is the first
page of the patient randomisation
If any questions are missed, an error message will
appear and you will be unable to proceed forward
PREDNOS 2
Online Randomisation
Patient eligibility:
If any questions
are answered in
a way that
makes the
patient ineligible,
you will be
unable to
proceed with the
randomisation
PREDNOS 2
Online Randomisation
Medical details:
Ensure both
relapses are
within 12
months of the
date of
randomisation
Ensure the
relapse dates
are added in
the correct
order
PREDNOS 2
Online Randomisation
Medical details:
Ensure the
group selected
matches the
current dose of
prednisolone
reported
PREDNOS 2
Online Randomisation
Medical
details:
Ensure the
dose of
prednisolone
entered is
less than or
equal to
15mg/m2
alternate
days
PREDNOS 2
Online Randomisation
This is the final page before randomisation
Once you click ‘Randomise’ you cannot amend
any information entered
PREDNOS 2
Online Randomisation
This final page gives the patient’s trial number, BSA and allocated bottle numbers
It explains how the study medication should be taken at time of URTI
PREDNOS 2
Following Randomisation…
Following randomisation, a Confirmation Email will be sent
On the Randomisation Form add the study number, treatment
pot numbers and body surface area
The participant’s study number should be added to the
completed Parent/ Participant Consent Form
Enter the number of study tablets to be taken when an URTI
develops on to the relevant Advice Letter to Parent/ Participant
Provide the parent/ participant with this advice letter, an URTI
fridge magnet, copy of the Patient Diary and a tablet crusher (if
required)
The patient's GP should be notified using the GP Letter provided
PREDNOS 2
Following Randomisation…
Complete a copy of the Clinical Trial Prescription Form
Fax/ email the completed prescription form and consent form to
BCH Pharmacy
Telephone BCH Pharmacy to confirm receipt
Post the wet ink original prescription form and a copy of the
consent form to BCH Pharmacy
Once received, BCH Pharmacy will contact the family directly to
discuss the study medication and arrange for it to be posted
BCH Pharmacy will post out: two pots (100 tablets) of study
medication, an electronic thermometer, and a guidance letter
(non-patient specific)
PREDNOS 2
Assessments and Case Report Forms
Baseline assessment is due on the same day as consent and randomisation
Follow up assessments are due at 3,6,9 and 12 months within +/- 2 weeks of
the due date
Due dates of assessments are listed on the Confirmation Email
CRFs include the Baseline Data Collection Form (V2.2) and Follow-up Data
Collection Form (V1.2)
If there are more relapses, primary care visits, etc. to record than there is space
use the Follow-up Continuation Sheet (V1.2)
At each assessment the relevant age specific questionnaires should be
completed by the parent:
– Achenbach Child Behaviour Checklist (1.5-5 and 6-18 years)
– CHU-9D (5-18 years)
– PedsQL (2-4, 5-7, 8-12, and 13-18 years)
– EQ-5D (12-18 years)
PREDNOS 2
Assessments and Case Report Forms
The baseline form, follow up form and continuation sheet,
PedsQL, CHU-9D and EQ-5D can all be entered directly online
from site using the online data entry system
If a form is entered online at site, a paper copy is not required by
BCTU
Completed Achenbach and SAE forms cannot be entered online
at site and should be emailed, faxed or posted to BCTU to be
checked and entered online
Once forms for your patient have been entered online at BCTU,
you will be able to view these on the online system
PREDNOS 2
Baseline Form: Tips for Completion
Part C: Details of Any Current Therapy
Report all prednisolone doses received in the 6 months prior to randomisation,
up to and including the day of randomisation
If prednisolone was prescribed to treat the relapses reported at randomisation,
make sure treatment dates correspond to relapse dates, or provide explanation
if otherwise
Report all other immunosuppressive therapies received in the 6 months prior to
randomisation, up to and including any treatment on the day of randomisation
Part D: Details of Any Previous Therapy
Report all immunosuppressive therapy prescribed since diagnosis until 6
months prior to randomisation
If immunosuppressive therapies reported in Part C commenced over 6 months
prior to randomisation, they also need to be ticked in Part D
PREDNOS 2
Follow Up Form: Tips for Completion Part B and Part I: Reporting of Medication
Report long-term alternate day prednisolone and other immunosuppressive
therapies in Part B
Report prednisolone prescribed for relapse (daily and alternate day), and short
course/ single dose other immunosuppressive therapies, in Part I
Include any medication previously listed as ongoing on the next follow up form
Part C: URTIs and URTI Related Relapses
Common queries:
– Daily dose: Combined dose of study drug and background prednisolone
– Total number of tablets: Total study drug tablets taken over 6 day course
– URTI related relapse: Occurring within 14 days of URTI developing
If a patient attends a trial assessment part way through an URTI episode, any
outstanding data should be reported once available, and recorded on the same
follow up form
PREDNOS 2
Follow Up Form: Tips for Completion
Part C and Part D: Reporting of Relapses
Treatment: Standard relapse regimen refers to ISKDC regimen, variations on
this should be reported as Other treatment
Part E and Part H: Primary Care and Outpatient Visits
If weekly visits for blood tests or blood pressure checks occur, each visit should
be reported individually
If reporting an annual flu vaccination, the reason for consultation should be
recorded as Repeat prescription, and the treatment as a Prescription medicine
Part F: Hospital Admissions
Overnight hospitalisations require a SAE form to be completed
If a hospital admission is part way through at the time of a trial assessment, any
outstanding data should be reported once available, and recorded on the same
follow up form
PREDNOS 2 Online Forms
Once logged in, select the ‘Patients’ tab and go to
‘Find patient’
PREDNOS 2 Online Forms
Search for patients by trial number
When you have found the correct patient, click ‘View’
PREDNOS 2 Online Forms
Select the assessment form you want to enter from the list on the right hand side You will only be able to enter assessments that are ‘Due Now’ Click ‘Add’ to enter data for the appropriate assessment
PREDNOS 2 Online Forms:
Baseline Form Example
Tabs correspond with sections on the paper form
Outstanding data to be entered is listed in the bottom
left corner
PREDNOS 2 Online Forms:
Baseline Form Example
To enter
individual doses of
medication,
answer ‘yes’ to the
lead question,
click ‘Save’, and
you will then be
able to click ‘Add’
in the table
PREDNOS 2 Online Forms:
Baseline Form Example
This is the table opened as a sub form
Enter all data, and click ‘Save’ then ‘Return to
Follow Up Form’
PREDNOS 2 Online Forms:
Baseline Form Example
Once all information has been completed on the
form, click ‘Submit’
PREDNOS 2
Study Drug Dose Calculation
At each assessment, and between assessments if there is a
change in background prednisolone therapy, please re-calculate
the number of study tablets required at the time of URTI
A Dose Calculator is provided on the online system, and it is
recommended you use this at site
This updated information should then be transferred onto the
appropriate advice letter to parent/ participant
Any clinical queries relating to the study drug should be directed to
the CI: Prof Nick Web, Tel: 07896 818647 on the PREDNOS 2
hotline
PREDNOS 2
Online Dose Calculator
Once logged in, select the ‘Patients’ tab and go to ‘Calculate
Dose’
PREDNOS 2
Online Dose Calculator
All data should be entered for the specific patient, then click
‘Calculate Dose’
PREDNOS 2
Online Dose Calculator
The information on the final page will be sent to you in an
automatically generated email
This email is also received by the team at BCTU
PREDNOS 2
At the 12 Month Assessment…
A count of the remaining study medication is required
Prior to the 12 month appointment, look over previous follow up
forms to check the number of tablets used up to the last
assessment
At 12 month assessment, once URTIs since the last
assessment have been reported, count the number of study
drug tablets remaining to check this corresponds with all URTIs
reported throughout the follow up period
Any remaining study medication should then be posted back to
BCH Pharmacy for accountability
PREDNOS 2
SAE Reporting SAE Forms are provided in the Site File
Please complete as soon as you are aware of the SAE and fax/ email to BCTU
Serious adverse events are those that:
– resulted in death
– were life threatening
– required in-patient hospitalisation or prolongation of existing hospitalisation
– resulted in persistent or significant disability or incapacity
– resulted in a congenital anomaly or a birth defect
All overnight hospitalisations require a SAE form (except planned admissions for unrelated pre-existing conditions)
Make sure you are aware of your Trust’s policy for local reporting of SAEs
PREDNOS 2
SAE Forms: Tips for Completion Majority of SAEs are reported for hospitalisations due to relapse or infection. CI has
advised SAE forms for these events are completed as follows:
CTCAE Category:
– 15- Infection
– 23- Renal/ genitourinary
Relevant Medical History: Nephrotic syndrome to be listed
Causality Assessment:
– Relapse whilst on study medication: 4- Probably related to trial treatment
– Infection whilst on study medication: 3- Possibly related / 4- Probably related
– Infection or relapse when study medication has never been taken: 1- Unrelated
– Infection or relapse once study medication has been completed/ discontinued: Possibly/ Probably related for fortnight after medication finished, then Unrelated
Serious adverse events are those that:
– resulted in death
– were life threatening
– required in-patient hospitalisation or prolongation of existing hospitalisation
– resulted in persistent or significant disability or incapacity
– resulted in a congenital anomaly or a birth defect
All overnight hospitalisations require a SAE form (except planned admissions for unrelated pre-existing conditions)
Make sure you are aware of your Trust’s policy for local reporting of SAEs
PREDNOS 2
SAE Forms: Tips for Completion Action taken due to SAE:
– Study medication stopped during hospitalisation due to relapse: 1- Treatment permanently discontinued
– Course of study medication completed, or has never been taken: 6- N/A
SAE Expectedness:
– All hospitalisation due to relapse: Expected
– Hospitalisation due to infection during course of study medication, and for up to 2 weeks following completion: Expected
– Hospitalisation due to infection when study medication has never been taken, or over 2 weeks following completion: Unrelated
Date of resolution:
– Hospitalisation due to relapse: Date of discharge from hospital
– Hospitalisation due to infection: Date antibiotics finished (if prescribed)/ date of discharge
Serious adverse events are those that:
– resulted in death
– were life threatening
– required in-patient hospitalisation or prolongation of existing hospitalisation
– resulted in persistent or significant disability or incapacity
– resulted in a congenital anomaly or a birth defect
All overnight hospitalisations require a SAE form (except planned admissions for unrelated pre-existing conditions)
Make sure you are aware of your Trust’s policy for local reporting of SAEs
PREDNOS
A Few Notes… Patient Randomisation
You need to answer all questions on the randomisation notepad to recruit- ensure all relevant medical tests are carried out whilst patient is still within inclusion criteria parameters
Randomise around day 21 of open label treatment to provide BCH Pharmacy enough time to post out study drug, and ensure patient is steroid sensitive
Fax the consent form and prescription form, and post wet ink prescription form, to BCH Pharmacy immediately following randomisation due to tight turnaround
Provide the participant with the study diary and a tablet crusher (if required) from site
BCH Pharmacy will provide the study drug, a letter explaining administration of study drug, and one pot of urine dipsticks
If study medication is discontinued…
Participant is not withdrawn from study and should continue follow up as planned
Remaining study medication should be returned to BCH Pharmacy for accountability
PREDNOS 2 Contact Details General Websites:
– http://www.birmingham.ac.uk/PREDNOS
– http://www.birmingham.ac.uk/PREDNOS 2
Secure Trial Websites for Randomisation and Data Entry:
– https://www.trials.bham.ac.uk/PREDNOS
– https://www.trials.bham.ac.uk/PREDNOS 2
Trial Inboxes:
– PREDNOS-trial@trials.bham.ac.uk
– PREDNOS2@trials.bham.ac.uk/
Telephone: +44 (0)121 415 9132/ 9133
Fax: +44 (0)121 415 9135
Postal Address: Renal Trials Office, Birmingham Clinical Trials Unit, Robert Aitken
Institute, University of Birmingham, Edgbaston, Birmingham B15 2TT
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