1、.Subject recruitment procedures, including any advertisements used for recruiting trial subjects. Any written information to be provided to subjects. Investigators brochure. Available safety information. Information about payment and compensation available to subjects. Investigator current CV and/or
2、 other documents evidencing his/her qualification. Any other documents as requested by local IRB/IEC.5.1.5 A cover letter ,Submission Form sample (Appendix 1) or other format required by IRB/IEC must accompany the package , clearly identifying the documents enclosed, together with version dates/numb
3、ers.5.1.6 Obtain one copy of submission documentation for the project Central File.5.2 Review of approval documents5.2.1 Review the IRB/IEC approval documentation to ensure: . That all the information on the approval form, e.g. study title , sponsor name , reviewed documents version/date is correct.
4、 That the study and documents submitted have been clearly and unconditionally approved;. Whether the investigator or sub-investigator is member of IBR/IEC , if so ,obtain written confirmation that they didnt vote on any related matters.5.2.2 The following items should be checked:. A member of the investigational site study team serving as a member of the IBR/IEC and participating in the vote of approval for the study;. Inappropriate membership of IBR/IEC;. Poor approval documentation
