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Registerchecking of documents [GxP / QC / QA]
Dear Varsha,
Whatever activity is being performed needs to be documented immediately, either directly in the CRF or in any other source document (depending on the protocol requirements and on your SOPs).
If data are transcribed from a source document into the CRF, this needs to be checked for transcription errors. This check can be done at a later stage.
Some critical activities need to be checked by a second person at the time when they are done. Dispensing and dosing for instance.
Regarding the PI: no requirement in GCP for the PI to be there personally at the time of dosing. He can delegate this task to another trained and qualified physician.
Regards
Ohlbe
Whatever activity is being performed needs to be documented immediately, either directly in the CRF or in any other source document (depending on the protocol requirements and on your SOPs).
If data are transcribed from a source document into the CRF, this needs to be checked for transcription errors. This check can be done at a later stage.
Some critical activities need to be checked by a second person at the time when they are done. Dispensing and dosing for instance.
Regarding the PI: no requirement in GCP for the PI to be there personally at the time of dosing. He can delegate this task to another trained and qualified physician.
Regards
Ohlbe
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- checking of documents Varsha 2011-05-30 13:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- checking of documents drgunasakaran1 2011-05-30 21:07
- checking of documents Varsha 2011-05-31 16:28
- checking of documentsOhlbe 2011-05-30 23:49
- checking of documents Helmut 2011-05-30 23:57
- checking of documents Varsha 2011-05-31 16:32
- checking of documents Varsha 2011-05-31 16:31
- checking of documents Helmut 2011-05-30 23:57
- checking of documents drgunasakaran1 2011-05-30 21:07
Ing. Helmut Schütz