Protocol Deviation/Prompt Notice Sample Clauses

Protocol Deviation/Prompt Notice. Deviations from the Protocol are not permitted except when necessary to protect the safety, rights or welfare of subjects enrolled in the Study. Institution and/or Investigator will, within one (1) business day from occurrence, or such shorter time as may be specified in the Protocol, notify Sponsor in writing of any (a) deviation from the Protocol, including any deviations necessary to protect the safety, rights or welfare of subjects enrolled in the Study, (b) serious adverse event (as defined in the Protocol) which occurs to a subject in the Study or (c) communication with a regulatory or governmental agency concerning (i) the Study, including any requests to inspect, examine, copy or remove records of the Study, (ii) another study which might have an impact on the Study, (iii) any facility(ies) of Institution at which any Study- related activity is being performed, (iv) any Institution or Investigator personnel involved in the Study (including but not limited to Investigator), or (v) the qualification of Institution or Investigator to perform the Study. In addition, Institution and/or Investigator will promptly report to Sponsor any adverse event (as defined in the Protocol) which occurs to a subject enrolled in the Study. Sponsor will promptly advise Institution and Investigator of adverse reactions or side-effects related to the Study Drug which may become known to the Sponsor during the course of the Study. 1.2 Odchylky od protokolu/Okamžité oznámení. Odchylky Protokolu nejsou povoleny kromě situací, kdy je to nutné pro ochranu bezpečnosti, práv nebo zdraví subjektů zařazených do Studie. Poskytovatel zdravotních služeb a/nebo Zkoušející bude během jednoho (1) pracovního dne od výskytu nebo v kratší době podle případných specifikací v Protokolu informovat Zadavatele písemně o jakékoli (a) odchylce od Protokolu, včetně jakýchkoli odchylek nutných pro ochranu bezpečnosti, práv nebo zdraví pacientů zařazených do Studie, (b) závažné nežádoucí příhodě (definované v Protokolu), která se objeví u subjektu ve Studii nebo (c) komunikaci s regulačním nebo vládním orgánem týkající se (i) Studie, včetně jakýchkoli požadavků na inspekci, vyšetření, kopii nebo odstranění záznamů Studie, (ii) jiné studie, která může mít dopad na Studii, (iii) jakéhokoli (jakýchkoli) pracoviště(-ích) Poskytovatele zdravotních služeb, ve kterých je prováděna aktivita související se Studií, (iv) veškerého personálu Poskytovatele zdravotních služeb nebo Zkoušejícího, který se účastní S...
Sample 1
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Protocol Deviation/Prompt Notice. Deviations from the Protocol are not permitted except when necessary to protect the safety, rights or welfare of subjects enrolled in the Study. Institution will, within one (1) business day from occurrence, or as such shorter time as may be specified in the Protocol, but only on the condition that it is operationally possible, otherwise without undue delay. notify Sponsor , in writing of any (a) deviation from the Protocol, including any deviations necessary to protect the safety, rights or welfare of subjects enrolled in the Study (failure to comply with this part shall constitute reasonable grounds for Sponsor to terminate this Agreement as provided in Section 2 of the Agreement), (b) serious adverse event (as defined in the Protocol) which occurs to a subject in the Study or (c) communication with a regulatory or governmental agency concerning (i) the Study, including safety information, any requests to inspect, examine, copy or remove records of the Study, (ii) another study which might have an impact on the Study, (iii) any facility(ies) of Institution at which any Study-related activity is being performed, (iv) any Institution or Investigator personnel involved in the Study (including but not limited to Investigator), or (v) the qualification of Institution or Investigator to perform the Study. In addition, Institution will promptly report, within twenty- four (24) hours of making the discovery, to Sponsor and CRO any adverse event (as defined in the Protocol) which occurs to a subject enrolled in the Study. Sponsor will promptly advise, within twenty-four (24) hours of making the discovery, Institution of reportable adverse reactions or side-effects related to the Study Drug which may become known to the Sponsor during the course of the Study, if it is a business day, otherwise on the next working day after the day on which it became aware of the adverse reaction or adverse effects. 1.2
Sample 1
Protocol Deviation/Prompt Notice. Deviations from the Protocol are not permitted except to the extent necessary to protect the safety, rights or welfare of subjects enrolled in the Study (each, a “Study Subject”). Any such deviations must be fully, accurately, and contemporaneously documented in accordance with established procedures. Institution and/or Investigator will, within one (1) business day from occurrence, or as otherwise specified in the Protocol, notify Sponsor of any (a) deviation from the Protocol, including any deviation necessary to protect the safety, rights or welfare of Study Subjects; (b) serious adverse event (as defined in the Protocol) experienced by a Study Subject; or (c) communication with a regulatory agency concerning (i) the Study or the Study Drug, including any requests to inspect, examine, copy or remove records of the Study; or (ii) the qualification of Institution or Investigator to perform the Study. In addition, Institution and/or Investigator will promptly report to Sponsor any adverse event (as defined in the Protocol) 2.7 Odchylka od protokolu; neprodlené oznámení. Odchylky od Protokolu nejsou povoleny, s výjimkou rozsahu nezbytného k zajištění bezpečnosti a ochraně práv nebo dobrých životních podmínek subjektů zařazených do Studie (každý xxxx xxx jako „Subjekt hodnocení“). Všechny takové odchylky musejí být plně, přesně a souběžně zdokumentovány v souladu se zavedenými postupy. Zdravotnické zařízení a/nebo Zkoušející lékař do jednoho (1) pracovního dne od vzniku (nebo případně v jiné lhůtě, pokud tak stanovuje Protokol) oznámí Zadavateli jakoukoli (a) odchylku od Protokolu, včetně odchylek nezbytných k zajištění bezpečnosti a ochraně práv nebo dobrých životních podmínek Subjektů hodnocení; (b) závažnou nežádoucí příhodu (dle definice v Protokolu), kterou prodělal Subjekt hodnocení; nebo (c) komunikaci s kontrolním úřadem týkající se (i) Studie nebo Hodnoceného přípravku, včetně veškerých žádostí o kontrolu, zkoumání, kopírování nebo odstraňování záznamů Studie experienced by a Study Subject and will assist Sponsor or its designee in evaluating such adverse events. During the Study and for a period of one (1) year following completion or early termination of the Study, Sponsor will report to Investigator any information that, in Sponsor’s sole judgment, could directly affect the health or safety of past or current Study Subjects, influence the conduct of the Study, or alter the IRB’s approval to continue the Study. Investigator will work with the IRB ...
Sample 1
Protocol Deviation/Prompt Notice. Deviations from the Protocol are not permitted except when necessary to protect the safety, rights or welfare of subjects enrolled in the Study. Institution and/or Investigator will, within one (1) business day from occurrence, or as specified in the Protocol, notify Sponsor of any (a) significant deviation from the Protocol, including any deviations necessary to protect the safety, rights or welfare of subjects enrolled in the Study, or (b) Serious Breach of which Institution or Investigator becomes aware. For the purposes of this provision, a “Serious Breach” shall mean a breach of ICH GCP or the Protocol, which is likely to affect (i) the safety and welfare of Study subjects; or (ii) the scientific integrity of the Study. In addition, the Investigator shall promptly inform the EC and any governmental authority as may be required by applicable laws of such deviation or breach.
Sample 1

Related to Protocol Deviation/Prompt Notice

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  • Proposal of Corrective Action Plan In addition to the processes set forth in the Contract (e.g., service level agreements), if the Department or Customer determines that there is a performance deficiency that requires correction by the Contractor, then the Department or Customer will notify the Contractor. The correction must be made within a time-frame specified by the Department or Customer. The Contractor must provide the Department or Customer with a corrective action plan describing how the Contractor will address all performance deficiencies identified by the Department or Customer.

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