Emergency Amendments. If it is necessary in the opinion of the Institution or Principal Investigator to deviate from the Protocol on an emergency basis for the safety of the Trial Subjects (hereinafter defined), Institution will notify Sponsor and the responsible IEC as soon as practicable but, in any event, no later than five working days after the change is implemented. Any emergency change to the Protocol must be followed by a written Amendment. 2.2
Emergency Amendments. If it is necessary to change the Protocol on an emergency basis for the safety of the Trial Subjects (hereinafter defined), Institution and/or Principal Investigator will notify Sponsor and the responsible IEC as soon as practicable but, in any event, no later than five working days after the change is implemented. Any emergency change to the Protocol must be followed by a written Amendment. 2.2 Dodatky v naléhavých případech. Je-li v naléhavém případě nutné kvůli bezpečnosti subjektů klinického hodnocení (podrobný popis dále v této smlouvě) změnit protokol, instituce a/nebo hlavní zkoušející o tom musí informovat zadavatele a odpovědnou NEK co možná nejdřív, nejpozději však do pěti pracovních dní po zavedení změny. Po jakékoli naléhavé změně protokolu musí následovat písemný dodatek.
Emergency Amendments. If it is necessary to change the Protocol on an emergency basis for the safety of the Trial Subjects (hereinafter defined), Institution and/or Principal Investigator will notify Sponsor and the responsible IEC as soon as practicable but, in any event, no later than five working days after the change is implemented. Any emergency change to the Protocol must be followed by a written Amendment. 2.2 Dodatky v prípade núdze. Ak bude nevyhnutné zmeniť Protokol v prípade núdze z dôvodu bezpečnosti Pokusných osôb (definované nižšie), Inštitúcia a/alebo Zodpovedný skúšajúci túto skutočnosť oznámia Sponzorovi a príslušnej EK hneď ako to bude možné, ale v žiadnom prípade nie neskôr ako päť pracovných dní po zavedení danej zmeny. Akákoľvek zmena Protokolu v prípade núdze musí byť následne potvrdená písomným Dodatkom.
Emergency Amendments. Notwith- standing paragraph (c) of this section, if the designated official finds that there is an emergency requiring imme- diate action with respect to safety and security in air transportation or in air commerce that makes procedures in this section contrary to the public in- terest, the designated official may issue an amendment, effective without stay on the date the airport operator receives the notice of it. In such a case, the designated official must incor- porate in the notice a brief statement of the reasons and findings for the amendment to be adopted. The airport operator may file a petition for recon- sideration under paragraph (c) of this section; however, this does not stay the effective date of the emergency amend- ment.
Emergency Amendments. If it is necessary to change the Protocol on an emergency basis for 2.2 Dodatky v naléhavých případech. Je-li v naléhavém případě nutné kvůli bezpečnosti the safety of the Trial Subjects (hereinafter defined), Principal Investigator will notify Sponsor and the responsible IEC as soon as practicable but, in any event, no later than five working days after the change is implemented. Any emergency change to the Protocol must be followed by a written Amendment. subjektů klinického hodnocení změnit protokol (podrobný popis dále v této smlouvě), hlavní zkoušející o tom musí informovat zadavatele a odpovědnou NEK co možná nejdříve, nejpozději však do pěti pracovních dní od zavedení změny. Po jakékoli naléhavé změně protokolu musí následovat písemný dodatek.
Emergency Amendments. Notwith- standing paragraph (c) of this section, if the Assistant Administrator finds that there is an emergency requiring immediate action with respect to safe- ty and security in air transportation or in air commerce that makes proce- dures in this section contrary to the public interest, the Assistant Adminis- trator may issue an amendment, effec- tive without stay on the date the air- port operator receives the notice of it. In such a case, the Assistant Adminis- trator shall incorporate in the notice a brief statement of the reasons and find- ings for the amendment to be adopted. The airport operator may file a peti- tion for reconsideration under para- graph (c) of this section; however, this does not stay the effective date of the emergency amendment (EA). § 107.107 Changed conditions affecting security.
Emergency Amendments. If it is necessary to change the Protocol on an emergency basis for the safety of the Trial Subjects (hereinafter defined), Institution will notify Sponsor and the responsible IEC as soon as practicable but, in any event, no later than five working days after the change is implemented. Any emergency change to the Protocol must be followed by a written Amendment. 2.2 Dodatky v naléhavých případech. Je-li v naléhavém případě nutné kvůli bezpečnosti subjektů klinického hodnocení změnit protokol (podrobný popis dále v této smlouvě), instituce o tom musí informovat zadavatele a odpovědnou NEK co možná nejdříve, nejpozději však do pěti pracovních dní od zavedení změny. Po jakékoli naléhavé změně protokolu musí následovat písemný dodatek.
Emergency Amendments. If it is necessary to change the Protocol on an emergency basis for the safety of the Trial Subjects (hereinafter defined), Institution will notify Sponsor, INC Research and the responsible IEC as soon as practicable but, in any event, no later than five working days after the change is implemented. Any emergency change to the Protocol must be followed by a written Amendment. Mimořádné dodatky. Pokud je nutné změnit protokol v mimořádné situaci a s ohledem na bezpečnost subjektů hodnocení (definovaných dále), instituce toto co nejdříve oznámí zadavateli, společnosti INC Research a odpovědné nezávislé EK, nejpozději však do pěti pracovních dní po implementaci změny. Mimořádné změny protokolu musí být zaznamenány v písemném dodatku.
