Wednesday, March 02, 2011 Posted by Analyst IP
DCGI feels due to lack of clarity applications received for amendment to approved protocol of clinical trials are incomplete and lot of avoidable correspondence is being carried out. DCGI has come up with guidelines on notification to the agency regarding amendment of approved protocol.
DCGI has come up with guidelines on notification to the agency regarding amendment of approved protocol. Changes made to the Protocol and resultant amendments effected needs to be informed to the DCGI.
Amendments are categorised into three categories,
- Those amendments which do not require any infomation or permission.
- Those amendements which require to be infomed but need not wait for permission.
- Those amendments which require prior permission before implementation of the amendments.
A. Amendments that does not require notification to or permission of the Licensing Authority
- Administrative and Logistic changes.
- Minor protocol amendments and additional safety assessments in case the institutional ethics committee has already approved these changes.
B. Amendments that require notification to the Licensing Authority but need not wait for permission
- Additional Investigator sites.
- Change in investigator with the consent to withdraw from the earlier investigator.
- Amended Investigators Brochure, amended informed consent.
C. Amendments that require prior permission of the Licensing Authority
- Additional Patients to be recruited.
- Major changes in protocol with respect to study design, dose and treatment options.
- Any change in inclusion or exclusion criteria.
Tags: Amendment, BENOC, bioequivalence, ClinicalTrials, DCGI, Protocol, Regulatory