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1 US Investigator Meeting DIAS-4, Chicago, July 2011
DIAS 3&4Investigational Medicinal Products (IMP)
2US Investigator Meeting DIAS-4, Chicago, July 2011
Agenda
IMP formulation IMP shipment and storageDose Reconstitution of IMP IMP Accountability
3US Investigator Meeting DIAS-4, Chicago, July 2011
IMP Formulation
Supplied in vials containing white lyophilised powder for solution for injection
Contains either 9 mg desmoteplase or placebo
Reconstituted with 10 ml of WFI
Each patient will receive:90 μg/kg desmoteplase or placeboSingle IV bolus injection over 1-2 minutes
4US Investigator Meeting DIAS-4, Chicago, July 2011
This is how IMP looks!
•The initial supply of medication will consist of 2 packs.
•Don’t break the silver seal until it is used
150 x 113 x 58 mm
5US Investigator Meeting DIAS-4, Chicago, July 2011
IMP Storage
IMP must be stored at 2-8℃
Temperature must be monitored at least every working day and documented.
In case of temperature excursion CRA need to be notified immediately
Temperature will be monitored during transportation as well
6US Investigator Meeting DIAS-4, Chicago, July 2011
IMP Shipment
Cold Chain Shipment
Upon receipt:Check if the temperature during the transportation
was within 2-8 ℃
Acknowledge the IMP receipt by making a medication arrival call in IVRS/IWRS
7US Investigator Meeting DIAS-4, Chicago, July 2011
How to read TempTale
1. Hold down the stop button until the stop icon appears
2. No bell icon: IMP delivered within temperature rangeBell icon present: IMP did not arrive within accepted temperature limits. Wait for confirmation from Lundbeck CSC
TempTale needs to be returned to courier immediately!
8US Investigator Meeting DIAS-4, Chicago, July 2011
Randomisation
The IV/IWRS will be used for randomisation. - Screening number
- Subject’s Date Of Birth
- Subject’s NIHSS Score
- Date of Stroke Onset
- Time of Stroke Onset (24 hour clock format)
- Subject’s weight (in Kilograms)
The IV/IWRS will instruct the site in an e-mail and/or fax: - The IMP number to use
- The volume of mediciation to be administred
9US Investigator Meeting DIAS-4, Chicago, July 2011
2. Reconstitute lyophilized powder with 10 ml Water For Injection
Agitate gently until all particles of the study medication are dissolved
Reconstitution of IMP
1. Choose assigned IMP number
Check IMP number on IV/IWRS- Randomisation confirmation
Check vial and remove blue cap
Water
For Injection
10 ml
10US Investigator Meeting DIAS-4, Chicago, July 2011
Reconstitution of IMP
3. Prepare a syringe (accuracy 0,2ml) with volume of IMP as given by the IV/IWRS Randomisation confirmation
RANDOMIZATION FAX
Patient XXX
Volume: X,y ml
accuracy of 0,2 ml
4. Please flush i.v. line with 10 ml WFI or Normal Saline before and after IMP administration to avoid any interaction with infusion contents!
X,y ml
11US Investigator Meeting DIAS-4, Chicago, July 2011
IMP Inventory Form
12US Investigator Meeting DIAS-4, Chicago, July 2011
IMP Inventory Log
13US Investigator Meeting DIAS-4, Chicago, July 2011
IMP re-supply
Randomisation will trigger the IMP re-supply
After the 1st patient: 2 IMPs will be sent
After the 2nd patient: 1 IMP will be sent
14US Investigator Meeting DIAS-4, Chicago, July 2011
IMP return
Used IMP must be stored in refrigerator at 2-8 ℃ on site until the patient has had the Day 90 visit
After the patient has completed the study the IMP can be kept at ambient storage condition until it is returned
CRA to check accountability before IMP return
IMP to be returned to depot
Please contact CRA when you return IMP
15US Investigator Meeting DIAS-4, Chicago, July 2011
Thank you
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