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RegisterExpedited Review from IEC in case of change in study design [Regulatives / Guidelines]
Dear Mr.Prashant,
Change in the study design and increase in the sample size will not be eligible for Ethics Committee's Expedited approval.
Kindly be informed that as per the CDSCO's Minutes of the Meeting on matters relating to Global Clinical Trials Held On 17th October 2006 At IDMA Office - Mumbai, the following amendments require prior permission from DCGI along with Ethics committee full approval before implementation of the amendments.
i) Change of Principal Investigator
ii) Additional Patients to be recruited
iii) Major changes in protocol with respect to study design, dose and treatment options
For more details on the expedited review eligibility criteria for a study, check the following link
Expedited Approval Criteria
Change in the study design and increase in the sample size will not be eligible for Ethics Committee's Expedited approval.
Kindly be informed that as per the CDSCO's Minutes of the Meeting on matters relating to Global Clinical Trials Held On 17th October 2006 At IDMA Office - Mumbai, the following amendments require prior permission from DCGI along with Ethics committee full approval before implementation of the amendments.
i) Change of Principal Investigator
ii) Additional Patients to be recruited
iii) Major changes in protocol with respect to study design, dose and treatment options
For more details on the expedited review eligibility criteria for a study, check the following link
Expedited Approval Criteria
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Complete thread:
- Expedited Review from IEC in case of change in study design amatewadi 2012-01-09 12:46 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Expedited Review from IEC in case of change in study design Ohlbe 2012-01-09 15:54
- Expedited Review from IEC in case of change in study design amatewadi 2012-01-11 05:31
- New trial = new opinion Ohlbe 2012-01-11 10:40
- Expedited Review from IEC in case of change in study design amatewadi 2012-01-11 05:31
- Sample size: parallel ≠ 2× cross-over! Helmut 2012-01-09 16:22
- Expedited Review from IEC in case of change in study designdrgunasakaran1 2012-01-13 17:51
- Expedited Review from IEC in case of change in study design amatewadi 2012-01-22 14:26
- Expedited Review from IEC in case of change in study design Ohlbe 2012-01-09 15:54
Ing. Helmut Schütz