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RegisterApplicable clinical trials [Regulatives / Guidelines]
Dear All,
Does BA/BE studies can be considered as an Applicable Clinical trials?
If Yes, then As per the following guidance document "Guidance for Sponsors, Investigators and Institutional review boards. Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)" published on Feb. 2012, Does it requires to incorporate the statement as per the above guidance in informed consent form for the BA/BE studies?
Kindly give clarity of Interventional studies (IV study) and Non interventional (NIV studies) studies.
BA/BE studies comes under which category IV/NIV?
With Regards,
Maulik Patel
Edit: Document linked. [Helmut]
Does BA/BE studies can be considered as an Applicable Clinical trials?
If Yes, then As per the following guidance document "Guidance for Sponsors, Investigators and Institutional review boards. Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)" published on Feb. 2012, Does it requires to incorporate the statement as per the above guidance in informed consent form for the BA/BE studies?
Kindly give clarity of Interventional studies (IV study) and Non interventional (NIV studies) studies.
BA/BE studies comes under which category IV/NIV?
With Regards,
Maulik Patel
Edit: Document linked. [Helmut]
Complete thread:
- Applicable clinical trialsmaulik963 2012-02-22 05:03
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Applicable clinical trials Helmut 2012-02-22 14:18
- Applicable clinical trials drgunasakaran1 2012-02-23 03:28
Ing. Helmut Schütz