PI Sponsor Application for approval of a multicentre clinical trial ...
PI Sponsor Application for approval of a multicentre clinical trial ...
PI Sponsor Application for approval of a multicentre clinical trial ...
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<strong>PI</strong> <strong>Sponsor</strong><br />
understandable text <strong>for</strong> ordinary people<br />
<strong>for</strong> the website <strong>of</strong> the Elisabethinen hospital<br />
(if applicable)<br />
servicecentre <strong>for</strong> <strong>clinical</strong> <strong>trial</strong>s<br />
sabine.metz@elisabethinen.or.at<br />
assessment <strong>of</strong> the<br />
contract<br />
(lawer Elisabethinen)<br />
assessment <strong>of</strong><br />
insurance policy<br />
(lawer Elisabethinen)<br />
assessment <strong>of</strong><br />
understandable text<br />
(Elisabethinen hospital)<br />
all documents<br />
o.k.<br />
<strong>Application</strong> <strong>for</strong> <strong>approval</strong> <strong>of</strong> a <strong>multicentre</strong> <strong>clinical</strong> <strong>trial</strong><br />
according to Austrian Medical law<br />
contract<br />
application <strong>for</strong>m <strong>of</strong> the Austrian EC,<br />
insurance policy, draft version <strong>of</strong> contract<br />
submission <strong>of</strong> at least 3 contracts to managing<br />
director <strong>for</strong> signing<br />
(service centre <strong>for</strong> <strong>clinical</strong> <strong>trial</strong>s)<br />
<strong>trial</strong> is ready to start<br />
assessment as<br />
leading ethics<br />
comittee<br />
<strong>PI</strong> will get an invitation<br />
introduction <strong>of</strong> the<br />
study by <strong>PI</strong><br />
submit application documents<br />
EC Land OÖ<br />
http://ooeethikkommission.gespag.at<br />
or<br />
<strong>approval</strong><br />
o.k.<br />
assessment as local<br />
EC (appropriatness <strong>of</strong><br />
the <strong>PI</strong> and the <strong>trial</strong><br />
centre
<strong>PI</strong><br />
understandable text <strong>for</strong> ordinary people<br />
<strong>for</strong> the website <strong>of</strong> the Elisabethinen hospital<br />
(if applicable)<br />
servicecentre <strong>for</strong> <strong>clinical</strong> <strong>trial</strong>s<br />
sabine.metz@elisabethinen.or.at<br />
assessment <strong>of</strong> the<br />
contract<br />
(lawer Elisabethinen)<br />
assessment <strong>of</strong><br />
insurance policy<br />
(lawer Elisabethinen)<br />
assessment <strong>of</strong><br />
understandable text<br />
(Elisabethinen hospital)<br />
all documents<br />
o.k.<br />
<strong>Application</strong> <strong>for</strong> <strong>approval</strong> <strong>of</strong> a monocentre <strong>clinical</strong> <strong>trial</strong><br />
according to Austrian Medical Law<br />
contract<br />
application <strong>for</strong>m <strong>of</strong> the Austrian EC,<br />
insurance policy, draft version <strong>of</strong> contract<br />
submission <strong>of</strong> at least 3 contracts to managing<br />
director <strong>for</strong> signing<br />
(service centre <strong>for</strong> <strong>clinical</strong> <strong>trial</strong>s)<br />
<strong>trial</strong> is ready to start<br />
<strong>Sponsor</strong><br />
submit application documents<br />
EC Land OÖ<br />
http://ooeethikkommission.gespag.at<br />
assessment as<br />
leading ethics<br />
comittee<br />
<strong>PI</strong> will get an invitation<br />
introduction <strong>of</strong> the<br />
study by <strong>PI</strong><br />
<strong>approval</strong><br />
o.k.
<strong>Application</strong> within a <strong>clinical</strong> <strong>trial</strong> according to Austrian Law <strong>of</strong><br />
Medical Products<br />
<strong>PI</strong><br />
understandable text <strong>for</strong> ordinary people<br />
<strong>for</strong> the website <strong>of</strong> the Elisabethinen hospital<br />
(if applicable)<br />
servicecentre <strong>for</strong> <strong>clinical</strong> <strong>trial</strong>s<br />
sabine.metz@elisabethinen.or.at<br />
assessment <strong>of</strong> the<br />
contract<br />
(lawer Elisabethinen)<br />
assessment <strong>of</strong><br />
insurance policy<br />
(lawer Elisabethinen)<br />
assessment <strong>of</strong><br />
understandable text<br />
(Elisabethinen hospital)<br />
all documents<br />
o.k.<br />
contract<br />
application <strong>for</strong>m <strong>of</strong> the Austrian EC,<br />
insurance policy, draft version <strong>of</strong> contract<br />
submission <strong>of</strong> at least 3 contracts to managing<br />
director <strong>for</strong> signing<br />
(service centre <strong>for</strong> <strong>clinical</strong> <strong>trial</strong>s)<br />
<strong>trial</strong> is ready to start<br />
<strong>Sponsor</strong><br />
submit application documents<br />
EC Land OÖ<br />
http://ooeethikkommission.gespag.at<br />
assessment as<br />
leading ethics<br />
comittee<br />
<strong>PI</strong> will get an invitation<br />
introduction <strong>of</strong> the<br />
study by <strong>PI</strong><br />
<strong>approval</strong><br />
o.k.
<strong>Application</strong> within an interventional study that is not subject to Austrian<br />
Medical Law or Austrian Law <strong>of</strong> Medical Products<br />
<strong>PI</strong><br />
understandable text <strong>for</strong> ordinary people<br />
<strong>for</strong> the website <strong>of</strong> the Elisabethinen hospital<br />
(if applicable)<br />
servicecentre <strong>for</strong> <strong>clinical</strong> <strong>trial</strong>s<br />
sabine.metz@elisabethinen.or.at<br />
assessment <strong>of</strong> the<br />
contract<br />
(lawer Elisabethinen)<br />
assessment <strong>of</strong><br />
insurance policy<br />
(lawer Elisabethinen)<br />
assessment <strong>of</strong><br />
understandable text<br />
(Elisabethinen hospital)<br />
all documents<br />
o.k.<br />
contract<br />
application <strong>for</strong>m <strong>of</strong> the Austrian EC,<br />
insurance policy, draft version <strong>of</strong> contract<br />
submission <strong>of</strong> at least 3 contracts to managing<br />
director <strong>for</strong> signing<br />
(service centre <strong>for</strong> <strong>clinical</strong> <strong>trial</strong>s)<br />
<strong>trial</strong> is ready to start<br />
<strong>Sponsor</strong><br />
submit application documents<br />
EC Land OÖ<br />
http://ooeethikkommission.gespag.at<br />
assessment as<br />
leading ethics<br />
comittee<br />
<strong>PI</strong> will get an invitation<br />
introduction <strong>of</strong> the<br />
study by <strong>PI</strong><br />
<strong>approval</strong><br />
o.k.
<strong>PI</strong><br />
understandable text <strong>for</strong> ordinary people<br />
<strong>for</strong> the website <strong>of</strong> the Elisabethinen hospital<br />
(if applicable)<br />
servicecentre <strong>for</strong> <strong>clinical</strong> <strong>trial</strong>s<br />
sabine.metz@elisabethinen.or.at<br />
assessment <strong>of</strong> the<br />
contract<br />
(lawer Elisabethinen)<br />
assessment <strong>of</strong><br />
insurance policy<br />
(lawer Elisabethinen)<br />
assessment <strong>of</strong><br />
understandable text<br />
(Elisabethinen hospital)<br />
all documents<br />
o.k.<br />
<strong>Application</strong> within a non interventional study<br />
contract<br />
application <strong>for</strong>m <strong>of</strong> the Austrian EC,<br />
insurance policy, draft version <strong>of</strong> contract<br />
submission <strong>of</strong> at least 3 contracts to managing<br />
director <strong>for</strong> signing<br />
(service centre <strong>for</strong> <strong>clinical</strong> <strong>trial</strong>s)<br />
<strong>trial</strong> is ready to start<br />
<strong>Sponsor</strong><br />
submit application documents<br />
EC Land OÖ<br />
http://ooeethikkommission.gespag.at<br />
assessment as<br />
leading ethics<br />
comittee<br />
<strong>PI</strong> will get an invitation<br />
introduction <strong>of</strong> the<br />
study by <strong>PI</strong><br />
<strong>approval</strong><br />
o.k.
Diplomant Betreuer<br />
laienverständlichen Text für Website des KH / Abteilung<br />
(wenn vorhanden)<br />
Servicestelle<br />
Prüfung<br />
Versicherungspolizze<br />
(Dr. Graziani)<br />
Studie in SAP<br />
Studiendatenbank<br />
anlegen<br />
(Servicestelle)<br />
Prüfung<br />
laienverständlichen<br />
Text<br />
(Univ.-Pr<strong>of</strong>. Dr.Schöfl)<br />
Prüfung<br />
Dokumente<br />
o.k.<br />
Procedere vor Beginn Diplomarbeiten<br />
EK-Antrag für Eintrag in SAP-Datenbank,<br />
Versicherungspolizze (wenn nötig), draft-Vertrag<br />
Melde<strong>for</strong>mular (s. Wissenspool - Ärztl. Dir.) inkl.<br />
Verträge ad GF zur Vertragsunterzeichnung<br />
(Studienkoordination)<br />
Studienbeginn<br />
EK Unterlagen einreichen<br />
EK Land OÖ<br />
http://ooeethikkommission.gespag.at<br />
Prüfung<br />
Einladung an Betreuer<br />
Vorstellung durch<br />
Diplomant u.<br />
Betreuer<br />
Votum o.k.<br />
Kopie ad<br />
Servicestelle
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