Adverse Events. Institution will ensure, through Principal Investigator, reporting of adverse events experienced by Study Subjects in accordance with instructions in the Protocol and applicable regulations. This includes, where required, prompt reporting by telephone or facsimile to CRO and/or Pfizer. Accordingly, CRO and/or Pfizer will, so far as is lawful, have full responsibility for the reporting of all adverse events to local and international regulatory and/or health authorities. 7.3
Appears in 3 contracts
Samples: Study Agreement, Study Agreement, Study Agreement
Adverse Events. Institution will ensure, through Principal Investigator, reporting of adverse events experienced by Study Subjects in accordance with instructions in the Protocol and applicable regulations. This includes, where required, prompt reporting by telephone or facsimile to CRO and/or and Pfizer. Accordingly, CRO and/or Pfizer will, so far as is lawful, have full responsibility for the reporting of all adverse events to local and international regulatory and/or health authorities. 7.3
Appears in 2 contracts
Samples: Clinical Study Agreement, Study Agreement
Adverse Events. Institution Institute will ensure, through Principal Investigator, reporting of adverse events experienced by Study Subjects in accordance with instructions in the Protocol and applicable regulations. This includes, where required, prompt reporting by telephone or facsimile to CRO and/or Pfizer. Accordingly, CRO and/or Pfizer will, so far as is lawful, have full responsibility for the reporting of all adverse events to local and international regulatory and/or health authorities. 7.37. Informovaný souhlas, nábor subjektů a nežádoucí pšíhody. 7.1
Appears in 1 contract
Samples: Clinical Study Agreement
Adverse Events. The Institution acknowledges that the Principal Investigator will ensure, through Principal Investigator, ensure reporting of adverse events experienced by Study Subjects in accordance with instructions in the Protocol and applicable regulations. This includes, where required, prompt reporting by telephone or facsimile to CRO and/or Pfizer. Accordingly, CRO and/or Pfizer will, so far as is lawful, have full responsibility for the reporting of all adverse events to local and international regulatory and/or health authorities. 7.3health
Appears in 1 contract
Samples: Study Agreement
Adverse Events. The Institution acknowledges that the Principal Investigator will ensure, through Principal Investigator, ensure reporting of adverse events experienced by Study Subjects in accordance with instructions in the Protocol and applicable regulations. This includes, where required, prompt reporting by telephone or facsimile to CRO and/or Pfizer. Accordingly, CRO and/or Pfizer will, so far as is lawful, have full responsibility for the reporting of all adverse events to local and international regulatory and/or health authorities. 7.37.2
Appears in 1 contract
Samples: Clinical Study Agreement
Adverse Events. Institution will ensure, through Principal Investigator, reporting of adverse events experienced by Study Subjects in accordance with instructions in the Protocol and applicable regulations. This includes, where required, prompt reporting by telephone or facsimile to CRO and/or and Pfizer. Accordingly, CRO and/or Pfizer will, so far as is lawful, have full responsibility for the reporting of all adverse events to local and international regulatory and/or health authorities. 7.3, i.e. SÚKL.
Appears in 1 contract
Samples: Clinical Study Agreement
Adverse Events. Institution will ensure, through Principal Investigator, reporting of adverse events experienced by Study Subjects in accordance with instructions in the Protocol and applicable regulations. This includes, where required, prompt reporting by telephone or facsimile to CRO and/or and Pfizer. Accordingly, CRO and/or Pfizer will, so far as is lawful, have full responsibility for the reporting of all adverse events to local and international regulatory and/or health authorities. 7.3of
Appears in 1 contract
Samples: Clinical Study Agreement