0118th March 2013 Investigator Meeting

STAKT - Drug supply

02

Clinical Trial Supplies

03Clinical Trial Supplies for STAKT

04

Kit Design: IWRS Stage 1

Kit design – 480mg / placebo twice daily dosing for 4.5 days

•30 x 80mg / placebo

Patient takes 6 capsules in the morning and 6

capsules in the evening = 2 bottles per patient for

the 4.5 days (6 capsules overage per patient)

Bottles are labelled with a 2 panel label

consisting of main body of text plus a peel off

portion to be attached to the CRF.Bottle size: 75cc

05

Kit Distribution – Stage 1

• 4 bottles sent to each of the 15 sites expected to recruit in Stage 1 (as always need both treatment arms available for next pt to be recruited)

• Each time bottles are dispensed it will automatically be replaced by the IWR system

• As treatment allocation is unpredictable at sites (e.g. a site may only ever recruit one patient), some bottles may never get used

• There are no re-supplies required for these patients, therefore new bottles shipped are for new patients.

06

Kit design – 360mg / 240mg / placebo twice daily dosing for 4.5 days

Kit design: IWRS Stage 2

• Patient takes 5 capsules in the morning (1 capsule from each bottle) and 5 capsules in the evening (1 capsule from each bottle) for 4.5 days (2 caps overage per bottle):

Bottle 1

10 x 80mg / placebo

Bottle 2

10 x 80mg / placebo

Bottle 3

10 x 80mg / placebo

Bottle 4

10 x 80mg / placebo

Bottle 5

10 x 40mg / placebo

Bottle 5

10 x 40mg / placebo

Regardless of the dose level the patient has been allocated to, to maintain the blind, all

patients will take 10 capsules per day, they may be all active, all placebo or a

combination of both.

07

Kit design – 360mg / 240mg / placebo twice daily dosing for 4.5 days

Kit design: IWRS Stage 2

•Each patient kit will contain 5 bottles to cover the 4.5 days of dosing required:

Bottle 1 – white label

Bottle 2 – White label

Bottle 3 – White label

Bottle 4 – While label

Bottle 5 – purple

label

Card, cell filler

Labelled and sealed

kit Bottles are labelled with a single panel label and the carton label is a 2 panel label consisting of main body of text plus a peel off portion to be attached to the CRF

Kit Size: 150x105x90mm

08

IWRS Kit distribution: Stage 2

• Upon site activation 3 kits will be shipped to a site

• Each time a patient kit is dispensed it will automatically be replaced by the IWR system

(single kit shipments)

• As treatment allocation is unpredictable at sites (e.g. a site may only ever recruit one or

two patients), some kits may never get used.

09

Site and user Spreadsheet:• Prior to Go-Live of the system, a site and user spreadsheet will need to be filled out. This document

can be updated on an on going basis through the life of the study, it contains information relating to the sites and users for the study.

• Each user for that site will receive an email with there account detailso 7-digit account number

• A separate email will be sent containing password informationo Temporary password – which will need to be changed the first time you log in to the system.o Passwords expiry every 90 days

Upon site activation the following documents will be sent out to the site:

• Site user guideo This document contains information on how to use the system along with helpdesk contact

numbers for the study.

IWRS – provided by Cenduit

010General IWRS information:

•C.I.R.T. = Cenduit Interactive Response Technology for Clinical Trials

• I.W.R.S. = Interactive Web Response System that provides the C.I.R.T. interface via

the internet.

C.I.R.T Functionality

•Subject Management

• Randomisation and un-blinding

•Drug Supply Tracking

• Site inventory and resupply

•Reporting

• Patient, Inventory and End User details

011Account Set Up

www.cenduitsolutions.com

7-digit Account Number8-digit Password

Temporary PasswordNew Password

Remember: Do not share your log in details

After 3 incorrect entries, you will be required to reset your password on the fourth attempt

012C.I.R.T Main menu

• Select the Protocol Number from the “Studies” menu option.

• Select a Form from the “Forms” menu option.

Forms for Site Users•Site Shipment Confirmation•Patient Randomisation•Discontinuation/Completion•Patient Un-blinding by Site

013General IWRS information:

•Sites will be activated by the lead site once all approvals and contracts are in place

• Site activation to be performed through the IWRS

• Once a site is activated an IMP order will be automatically raised and shipped to site

within 5 working days.

•On receipt of a shipment, the site must update the IWRS confirming receipt before the

IMP can be dispensed to patients.

• Once a patient has been randomised they will not require any further dispensing visits

in the IWRS however once the patient has completed treatment or is discontinued prior

to completion they must be discontinued in the IWRS.

014General IWRS information cont:

•Once all patients have entered into Stage 1, the IWRS will need to switch off Stage 1

and switch stage 2 on for recruitment.

• Un-blinding will be carried out by Peter Fox and his team, this will be done through the

IWR system

• Un-blinding should only be carried out for a medical emergency

• If you have issues using the system please contact the Cenduit helpdesk on:

• Toll-free helpdesk 00800 1012 1960

• Email address: global.helpdesk@cenduit.com

• Website: WWW.cenduitsolutions.com

• Or contact Kerry Tingley on 01403 212623 – during office hours

• Email address: kerry.tingley@thermofisher.com

015Randomisation

Patient randomisation:

•A site user randomises a patient through the IWRS using the randomisation form.

•The following information will need to be inputted into the system to create the

randomisation:

• Select site number

•Patient initials (3 digits required e.g. JAC or J-C)

•Patients DOB

•A randomisation response will be generated providing the patient number and kit

number to be dispensed, sites must keep confirmations as source

documentation.

•Patient number will consist of: 3 letter site code followed by 3 digit system generated

number, sequential by site e.g. ABC001

016Patient Discontinuation/Completion

• Once a patient has completed their treatment cycle, site users will need to access the

IRT and discontinue/complete the patient in the system.

Required Information:

1. Site Number2. Patient Number3. Patient’s Date of Birth4. Patient Status?

Early Discontinuation Completion of Study

5. Early Discontinuation or Completion Date

017

Destruction of IP and accountability

•Sites are to destroy expired and unused medication for both Stage 1 and Stage 2

• The lead site will confirm to each site when destruction can be carried out

•At the end of the trial a full accountability of drug products must be carried out and

certificates of delivery and returns must be signed and copies retained in the investigator

files.

018Any Questions:

Thank you