Prepare the required documents to be submitted to the IEC/IRB: according to ICH

Prepare the required documents to be submitted to the IEC/IRB:

Documents usually required by Ethics Committees

·   Investigator Brochure and up-to-date safety information.

·   Trial protocol (final version and amendments).

·   Consent form(s) and subject information sheets.

·   Subject recruitment procedures (e.g. advertisement

·   Information on payment and compensation available to subjects.

·   Current curriculum vitae for each investigator.

·   Any other document requested by the IEC/IRB.

                                                                   See ICH Guidelines 3.1.2

Obtain approval document from the Ethics Committee, which must identify the documents reviewed and state that the study is acceptable and can be initiated.

Send the approval document of the Ethics Committee, with a list of Committee members, to TDP/TDR/WHO as a supporting document for approval of the WHO Secretariat

Committee on Research Involving Human Subjects (SCRIHS).Prepare the application for Health Authority clearance in collaboration with TDR and other sponsoring agencies.

Prepare the application for product exportation/importation in collaboration with TDR and other sponsoring agencies.

If the IEC/IRB and others approve the trial, sign the final copy of the protocol and confirm in writing that he/she has read and understood, and will adhere to, the protocol, study procedures and ICH Good Clinical Practice, will collaborate with the monitor, and accords with TDR/sponsoring agencies on publications policy.

Submit requested documents to the Clinical Monitors, including:

1. Signed agreement to comply with this SOP (page 1).

2. Approved protocol, signed and dated.

3. Approved informed consent form and other subject information, advertisement (local language and English translation).

4. Investigator’ s and co-investigator’ s curriculum vitae (C.V.s).

5.  Authorized Staff Form (ASF).

6.  Product exportation/importation authorization.

7. Laboratory certification/list of normal laboratory ranges, dated and signed by Investigator.

8. Technical services agreement (TSA), signed and dated.

9. Signed agreement that the product will not be used before the Trial Initiation Monitoring Visit has been made and authorization obtained from the TDR Clinical Coordinator (if applicable).

10. Signed FDA 1572 form (if applicable, e.g. study under Investigational New Drug - IND).