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I am conducting one three way three period BE study,second period we have completed with washout period as per protocol but during third period we have increased that period by 3 days.Can this be acceptable as per regulatory requirement?or just we have fill the protocol deviation?
Somanth
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Dear Sir,
Any changes in the study design is considered as deviation and should be filed as protocol deviation as per regulatory norms.
The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favourable opinion from the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change in monitor(s), change of telephone number(s)).
The investigator, or person designated by the investigator, should document and explain any deviation from the approved protocol.
The investigator may implement a deviation from, or a change of, the protocol to eliminate an immediate hazard(s) to trial subjects without prior IRB/IEC approval/favourable opinion. As soon as possible, the implemented deviation or change, the reasons for it, and, if appropriate, the proposed protocol amendment(s) should be submitted:
(a) to the IRB/IEC for review and approval/favourable opinion,
(b) to the sponsor for agreement and, if required,
(c) to the regulatory authority(ies).
Thanks & Regards,
Dr.S.Gunasakaran,MBBS,MD,
Clinical Pharmacologist and Principal Investigator,
Azidus Research Laboratories Ltd,
Chennai.
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Dear somanath If the protocol says minimum days (for example minimum 7 days) of washout period, then no need to file protocol deviation otherwise needs to file.
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The following message was posted to: PharmPK
Somanth,
The severity of this issues depends on how the protocol was written. If the protocol is specific about the washout time, and the clinic did not follow that washout time, yes it is a protocol deviation (in this case I assume a planned deviation which received proper approval prior to happening). If however, your protocol indicates "Washout will be at least XX amount of time" and you have fulfilled at least that amount of time, then you have not deviated from your protocol.
Ultimately you are conducting a BE study. The integrity of the study results should not be compromised from this incident as the reason for the washout is to fully eliminate the previously administered drug product.
Cheers
Robert Lepage, M.Sc., CCRP
Manager, Biopharmaceutics
Pharma Medica Research Inc.
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