Subject Identification Log

Polish translation: rejestr kodów identyfikacyjnych uczestników badania

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:Subject Identification Log
Polish translation:rejestr kodów identyfikacyjnych uczestników badania
Entered by: Mariusz Listewnik
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08:40 Mar 21, 2018
English to Polish translations [PRO]
Medical - Medical: Pharmaceuticals / Clinical studies
English term or phrase: Subject Identification Log
Protokół badania. Czy można log tłumaczyć tu jako rejestr?
Mariusz Listewnik
Poland
Local time: 11:21
rejest kodów identyfikacyjnych uczestników badania
Explanation:
Subject ID Log
(08/30/2007)
Question 1:
I have a questions with regard to the Subject Identification Log. What is the purpose of this log? What should be the minimum documentation on this log? I believe its purpose are: a. its used to record subject confidential details. This includes name and a hospital registration / social security no. b. the purpose is to link the subject initials and ID no. to the name and hosp registration no. c. at the end of the study this is retained with the investigator while the rest of the documents are archived so that during inspections these can be made available.

Answer 1:
FDA's regulations do not use or define the term, "subject identification log," nor does that term appear in FDA's official guidance, the ICH E-6, "Good Clinical Practice: Consolidated Guidance." ICH E6 does, however, include the following definitions and terms:

Section 1.58: "Subject Identification Code" is defined as "A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial-related data."

Section 8.3.20, Subject screening log: To document identification of subjects who entered pretrial screening

Section 8.3.21, Subject identification code list: To document that investigator/institution keeps a confidential list of names of all subjects allocated to trial numbers on enrolling in the trial. Allows investigator/institution to reveal identity of any subject

Section 8.3.22, Subject enrollment log: To document chronological enrollment of subjects by trial number

Your interpretation of the purpose of a "subject identification log" seems reasonable to me.

http://firstclinical.com/fda-gcp/?show=RE SubjectIDLog&type=


ccccc
1.58 Subject Identification Code - Kod identyfikacyjny uczestnika badania
Niepowtarzalny kod identyfikacyjny przydzielany przez badacza każdemu uczestnikowi badania, dla zachowania poufności jego danych osobowych. Kod identyfikacyjny używany jest zamiast nazwiska tej osoby w przypadku konieczności raportowania zdarzeń niepożądanych lub przekazywania danych związanych z badaniem.
https://www.gcppl.org.pl/Portals/2/advertisings/ICH_GCP_E6_R...
Selected response from:

Frank Szmulowicz, Ph. D.
United States
Local time: 05:21
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +1rejest kodów identyfikacyjnych uczestników badania
Frank Szmulowicz, Ph. D.


  

Answers


2 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
subject identification log
rejest kodów identyfikacyjnych uczestników badania


Explanation:
Subject ID Log
(08/30/2007)
Question 1:
I have a questions with regard to the Subject Identification Log. What is the purpose of this log? What should be the minimum documentation on this log? I believe its purpose are: a. its used to record subject confidential details. This includes name and a hospital registration / social security no. b. the purpose is to link the subject initials and ID no. to the name and hosp registration no. c. at the end of the study this is retained with the investigator while the rest of the documents are archived so that during inspections these can be made available.

Answer 1:
FDA's regulations do not use or define the term, "subject identification log," nor does that term appear in FDA's official guidance, the ICH E-6, "Good Clinical Practice: Consolidated Guidance." ICH E6 does, however, include the following definitions and terms:

Section 1.58: "Subject Identification Code" is defined as "A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial-related data."

Section 8.3.20, Subject screening log: To document identification of subjects who entered pretrial screening

Section 8.3.21, Subject identification code list: To document that investigator/institution keeps a confidential list of names of all subjects allocated to trial numbers on enrolling in the trial. Allows investigator/institution to reveal identity of any subject

Section 8.3.22, Subject enrollment log: To document chronological enrollment of subjects by trial number

Your interpretation of the purpose of a "subject identification log" seems reasonable to me.

http://firstclinical.com/fda-gcp/?show=RE SubjectIDLog&type=


ccccc
1.58 Subject Identification Code - Kod identyfikacyjny uczestnika badania
Niepowtarzalny kod identyfikacyjny przydzielany przez badacza każdemu uczestnikowi badania, dla zachowania poufności jego danych osobowych. Kod identyfikacyjny używany jest zamiast nazwiska tej osoby w przypadku konieczności raportowania zdarzeń niepożądanych lub przekazywania danych związanych z badaniem.
https://www.gcppl.org.pl/Portals/2/advertisings/ICH_GCP_E6_R...

Example sentence(s):
  • >
Frank Szmulowicz, Ph. D.
United States
Local time: 05:21
Native speaker of: Native in EnglishEnglish, Native in PolishPolish
PRO pts in category: 202
Notes to answerer
Asker: Dzięki za pomoc!


Peer comments on this answer (and responses from the answerer)
agree  Marquis: Dokladnie :-)) Dziękuje. Również pozdrawiam. Za wcześnie jeszcze na zauważenie "r" :-)))
1 hr
  -> Dziękuję Marquis. Zgubiłem r na końcu rejestru. Serdecznie pozdrawiam.
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