PREDNOS Trials: Study Procedures and Case Report Forms...PREDNOS 2 Randomisation Procedure Randomisation should occur on the day of consent and baseline assessment Fully complete the

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


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


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


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


Medical details:

Ensure the

group selected

matches the

current dose of

prednisolone

reported

PREDNOS 2


Medical

details:

Ensure the

dose of

prednisolone

entered is

less than or

equal to

15mg/m2

alternate

days

PREDNOS 2


This is the final page before randomisation

Once you click ‘Randomise’ you cannot amend

any information entered

PREDNOS 2


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’


Search for patients by trial number

When you have found the correct patient, click ‘View’


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



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



This is the table opened as a sub form

Enter all data, and click ‘Save’ then ‘Return to

Follow Up Form’



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


All data should be entered for the specific patient, then click

‘Calculate Dose’

PREDNOS 2


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









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









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:

– [email protected]

– [email protected]/

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

Documents

PREDNOS Trials: Study Procedures and Case Report Forms...PREDNOS 2 Randomisation Procedure Randomisation should occur on the day of consent and baseline assessment Fully complete the