Independent Safety Officer (ISO)

Czech translation: nezávislý bezpečnostní konzultant

12:24 Jan 14, 2013
English to Czech translations [PRO]
Medical - Medical: Health Care / clinical trials
English term or phrase: Independent Safety Officer (ISO)
Additionally, if a recommendation by the Independent Safety Officer (ISO) is made to stop the study due to an unfavorable safety profile, the ISO will contact a group of individuals designated by XXXX as the Sponsor Management Committee (SMC) for this study.
zidlik
Local time: 09:58
Czech translation:nezávislý bezpečnostní konzultant
Explanation:
Možná takto, zde je popis.

Appointment of the Safety Officer



The Principal Investigator typically proposes an independent Safety Officer, usually a physician, with relevant study and disease specific expertise, and submits the individual's name for review and approval by the NIAMS Program Officer. NIAMS invites the individual to serve as a study's Safety Officer. The Safety Officer is appointed and receives the manual of operating procedures, which typically contains the study protocol and safety monitoring plan, before study enrollment begins.



II. Independence of the Safety Officer



To remain objective, the Safety Officer must maintain independence from the study. Accordingly, the Safety Officer should not be directly involved in the conduct of the study and should not have scientific, proprietary, financial or other interests that may affect independent decision-making.



Current collaborators of the Principal Investigator are not eligible. The letter of invitation to prospective Safety Officers should state the requirement of independence. In addition, potential Safety Officers must sign a Conflict of Interest Statement prior to the appointment. Annually, the NIAMS Program Officer will seek reconfirmation that no conflict of interest exists. Such a statement may also be required prior to each review.

Selected response from:

Ales Horak
Czech Republic
Local time: 09:58
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +2nezávislý bezpečnostní konzultant
Ales Horak
3pracovník pro bezpečnost
Eva Machovcova


  

Answers


15 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
independent safety officer (iso)
nezávislý bezpečnostní konzultant


Explanation:
Možná takto, zde je popis.

Appointment of the Safety Officer



The Principal Investigator typically proposes an independent Safety Officer, usually a physician, with relevant study and disease specific expertise, and submits the individual's name for review and approval by the NIAMS Program Officer. NIAMS invites the individual to serve as a study's Safety Officer. The Safety Officer is appointed and receives the manual of operating procedures, which typically contains the study protocol and safety monitoring plan, before study enrollment begins.



II. Independence of the Safety Officer



To remain objective, the Safety Officer must maintain independence from the study. Accordingly, the Safety Officer should not be directly involved in the conduct of the study and should not have scientific, proprietary, financial or other interests that may affect independent decision-making.



Current collaborators of the Principal Investigator are not eligible. The letter of invitation to prospective Safety Officers should state the requirement of independence. In addition, potential Safety Officers must sign a Conflict of Interest Statement prior to the appointment. Annually, the NIAMS Program Officer will seek reconfirmation that no conflict of interest exists. Such a statement may also be required prior to each review.



Ales Horak
Czech Republic
Local time: 09:58
Works in field
Native speaker of: Native in CzechCzech
PRO pts in category: 8
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  Petra Kumar
55 mins
  -> díky

agree  Pavel Prudký
6 hrs
  -> díky
Login to enter a peer comment (or grade)

16 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
independent safety officer (iso)
pracovník pro bezpečnost


Explanation:
...

Eva Machovcova
Local time: 09:58
Native speaker of: Czech
Login to enter a peer comment (or grade)



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