Bioequivalence and Bioavailability Forum

❝ I wanted to know is it necessary to have IEC/IRB approval for Principal Investigator's curriculam vitae each time we submitting an application for approval to IEC for any protocol?

Yes, it is necessary to get the approval of PI CV before the initiation of the study. Because IEC should know the concerned PI appointed for a particular study.

(CROs generally follows to keep appendices in protocol which has CV of PI so the IEC will approve the protocol along with PI CV) .

A precise information stating in ICH E6 is as follows:ICH E6 reference
Section 3 –
3.1.2 - The IRB/IEC should obtain the following documents..............the investigator’s current curriculum vitae and/or other documentation evidencing qualifications, and any other documents that the IRB/IEC may need to fulfil its responsibilities.
3.1.3 - The IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.
Section 4 - 4.1.1 - The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority (ies).

Before a trail/study is initiated IEC will check all the relevant documents with respect to protocol and the concerned persons CV (Ex: PI and CI....) involved in the study and will approve the same.

❝ also can anyone please let me know if we have IEC approval on version-1 of study protocol and then we make any changes to protocol and prepare version-2 and apply for the IEC approval again for expedite review, should the summary of changes from version-1 to version-2 submit to IEC and IEC should have review and approved that or it is not necessary?

Yes, the summary of changes / amendments (from V1 to V2) be submitted to IEC for approval. Submission of changes to IEC will give a clear picture of changes from version – 1 to 2 and obtaining the approval for the same will also be helpful to avoid questions raised by regulatory authorities.

How ever it is the responsibility of CRO (sponsor) to intimate to IEC to get approval for the same.

In ICH E6 guideline (reference link attached above)
Section 4.5 –
4.5.2 - 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,.........
4.5.3 - The investigator, or person designated by the investigator, should document and explain any deviation from the approved protocol to IEC members.

As stated above changes/amendments done in the protocol should be intimated to the IEC for approval.

How ever in case of condition stated in section 3.3.7 of ICHE6- .......except when necessary to eliminate immediate hazards to the subjects or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change of monitor(s), telephone number(s)IEC approval need not be needed.

Regards,

RVR