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Approval: journal numbers Site Document stating full approval obtained Consort Agreemnt signed EthicsCA: Medicines CA: Device DPA, If not EU Ready to recruit.

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Presentation on theme: "Approval: journal numbers Site Document stating full approval obtained Consort Agreemnt signed EthicsCA: Medicines CA: Device DPA, If not EU Ready to recruit."— Presentation transcript:

1 Approval: journal numbers Site Document stating full approval obtained Consort Agreemnt signed EthicsCA: Medicines CA: Device DPA, If not EU Ready to recruit AT X EK Nummer: 24-261 ex 11/12 n/a ReferenzNummer INS-621000-0343 - June BE X S 1/5-12 Not a problem if deeded follows Ethics - CH (BORL) Remember to make sponsor statement X (X BORL ) S 7/6-12 A asked for copy 7/6 Not needed DE X P - DK xX Protokol nr. : H-4-2012-028 n/a Protokol nr. LMST20120347 29 xMay ES xx Código: HULP:3450 HULP: 3453 NBPC n/a -May FR x P - IE Pending A 26/6 asked for copy n/a - IT xX Atti 549/12- all.3 n/a -May NL (x)X (X Haemoscan ) S n/a - SE X P n/aP- UK x S n/a - P:pending A: Accepted S: submitted n/a: Not Applicable

2 Insurance Site Insurance policy validated by PI/site Insurance requested Estimated no. of participan ts AT x x5-10 BE-5 CHx5 DE xx5 DK-20 ES xx35 FRx5-20 IE-10-25 IT-5 NL-15 SE Asked lena to validate plastic surgery with ACE in Sweden x5 UK-5

3 Monitoring SiteMonitoring Unit/CRC Contacted Contract btw PI and Monitoring unit signed ECRIN assistance requested AT Initiation visit 28/6-12 BE Local CTC CHx DE KKS contacted DKxx ES Adelina will get back with alternative to Caiber x FR IE(x) ITxongoingx NLx SE UK

4 Devices at sites SiteNIRO200nxInvosNIRO300Oxyprem v 1.2 ATx BEXx CHxx DEX DKxX ESxX FRX IEX ITX NLxnew SEX UKx Adult sensors are to be used with the INVOS Medium sensors are to be used with the NIRO200nx


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