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GRACE WP9/10 Next season: Practical issues

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.

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GRACE WP9/10 Next season: Practical issues

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  1. GRACE WP9/10Next season: Practical issues GRACE Meeting, Cambridge, September 18, 2008

  2. 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.

  3. Protocol amendment The WP9 & WP10 protocol needs to be updated. Reason 1: New networks Reason 2: Third season

  4. GRACE WP9-10Study 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

  5. 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)

  6. 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.

  7. GRACE WP9-10Bottling campaigns study medication

  8. GRACE WP9-10Bottling 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

  9. New chest X-ray SOP & Form Recently a new chest X-ray SOP & a new X-ray requisition form was sent out. • Make sure all radiologists involved in GRACE will be informed • Only in new “blue” patient packs the new form has to be used (no replacement in “old” packs).

  10. 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

  11. 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?

  12. 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

  13. It’s time for…. GRACE cakes again!!

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