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RegisterAudio video recording of informed consent [Regulatives / Guidelines]
Dear all, and particularly contributors from India,
A Gazette notification informing of amendments to Schedule Y of the Drug and Cosmetic Rules has recently been published.
Do I understand it correctly that an audio and video recording of the informed consent process is no longer required for BE trials ? At least for BE trials for generics (may still be required for a BE trial on a new chemical entity) ?
A Gazette notification informing of amendments to Schedule Y of the Drug and Cosmetic Rules has recently been published.
Do I understand it correctly that an audio and video recording of the informed consent process is no longer required for BE trials ? At least for BE trials for generics (may still be required for a BE trial on a new chemical entity) ?
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Audio video recording of informed consentOhlbe 2015-08-20 18:03 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Audio video recording of informed consent suchit_bhavsar 2015-08-21 07:30
- Audio video recording of informed consent sathish.munaga 2015-10-14 12:19
- Audio video recording of informed consent suchit_bhavsar 2015-08-21 07:30
Ing. Helmut Schütz