Transcript Headertitel

GRACE WP9/10
Next season:
Practical issues
GRACE Meeting,
Cambridge, September 18, 2008
Reports for ethical committee
(EC)
An annual safety report & Progress report to
update your ethical committee will be sent
in the near future.
The European Clinical Trial directive
guidelines will be followed.
Protocol amendment
The WP9 & WP10 protocol needs to be
updated.
Reason 1: New networks
Reason 2: Third season
GRACE WP9-10
Study medication
Extension of expiry date (1st Sept 08 to 1st Sept 09)
On 22nd August NNCs were sent
– small additional labels with the batch number and
new expiry date
– SOP to describe the relabel procedure
> by pharmacist or NNF
– form to complete when the labels are attached
– new certificate of conformity
The completed forms showing that the relabeling has
been performed need to be faxed back to Gilly O’Reilly
GRACE WP9-10
Study medication
Medication SOPs
• Management of Clinical Trial Drug Supplies SOP
(Instructions for Drug Receipt Log, Storage,
randomisation, unblinding)
• Drug Transfer Log (to be completed if Drug is
transferred between GPs or back to pharmacy for
new expiry relabel)
• Drug Receipt Log (to be completed and faxed to Gilly
when Drug is allocated to GPs)
GRACE WP9-10
Study medication
Medication SOPs (2)
• Drug Accountability Log (NNCs to complete the drug
accountability log on GOS)
• Drug temperature log (to complete once a week,
min/max temp)
• What to do with the empty returned medication
bottles?
A “destruction” instruction (update SOP) will follow.
GRACE WP9-10
Bottling campaigns study medication
Campaign 1 Autumn 07
Re-lable Hungarian bottles
Country
Boxes
numbers
Boxe
s
supp
lied
Bottl
es
supp
lied
(10
bottl
es
per
box)
Bottles used
07/07/08
Antwerp
1-34
34
340
48
Ghent
35-68
34
340
Southampton
69-102
34
Cardiff
103-136
Utrecht
Box
numbers
Boxes
supplied
Bottles
supplied (10
bottles per
box)
443-476
34
340
19
0
0
340
33
0
0
34
340
36
0
0
137-170
34
340
70
477-510
34
340
Lodz
171-204
34
340
141
511-612
102
1020
Bratislava
205-238
34
340
0
613-646
34
340
Balatonfured
239-272
0
0
withdrawn
withdrawn
withdrawn
Jönköping
273-306
34
340
14
0
0
Barcelona
307-340
34
340
47
0
0
Mataro
341-374
34
340
36
0
0
Rotenberg
375-408
34
340
0
0
0
Milano
409-442
34
340
0
0
0
17
Bottl
es
supp
lied
(10
bottl
es
per
box)
Campaign 3 ?
Box
numbers
239-255
Box
es
sup
plie
d
Campaign 2 Autumn 08
169
Slovenia
256-264
9
90
647-680
34
340
France
265-272
8
80
681-714
34
340
408
34
272
Box
nu
mb
ers
Boxe
s
supp
lied
248
Bottl
es
supp
lied
(10
bottl
es
per
box)
GRACE WP9-10
Bottling campaigns study medication
Campaign 1 > Autumn ’07
Re-lable Hungarian bottles (for new networks)
Campaign 2 > Autumn ’07
(Additional) supplies for France, Slovenia, Poland,
Antwerp, Utrecht, Bratislava
Campaign 3 > Not planned yet
New chest X-ray SOP & Form
Recently a new chest X-ray SOP & a new
X-ray requisition form was sent out.
1. Make sure all radiologists involved in
GRACE will be informed
2. Only in new “blue” patient packs the new
form has to be used (no replacement in
“old” packs).
New sputum form & Lab manual
New sputum form > to be replaced in all
“blue” patient packs (see SOP)
Complete tasklist-questionnaire and return
by fax
Changes in lab manual > see presentation
Lab
Missing controls
Season 1: 1692 inclusions in total
862 WP9 &10 patients versus 830 controls
So 32 controls are missing.
What to do? Is it an option to include these
controls in season 2 and if so, when?
New dates NNF/NNC
teleconferences
Participants: NNFs/NNCs & lab representatives
Date (Tuesday, 14.00 – 15.00 hrs)
• 14 October
• 28 October
• 11 November
• 25 November
• 9 December
• 23 December
It’s time for….
GRACE cakes again!!