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Roles & Responsibilities of CREC and local ECs for Initial Review

Roles & Responsibilities of CREC and local ECs for Initial Review. PI/Sponsor submit Protocol. CREC. Local EC. Reviews. Local Issues? (AF09/01). Approve. Automatically Approved. Local ECs. or Expedited Review. ภายใน 2 วันทำการ.

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Roles & Responsibilities of CREC and local ECs for Initial Review

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  1. Roles & Responsibilities of CREC and local ECs for Initial Review PI/Sponsor submit Protocol CREC Local EC Reviews Local Issues? (AF09/01) Approve Automatically Approved Local ECs or Expedited Review ภายใน 2 วันทำการ

  2. Roles & Responsibilities of CREC and local ECs for Continuing Review* *Except local SAE, Protocol Deviation/Violation PI/Sponsor submit Protocol CREC Local EC Local issues PI’s Facilities Community attitude Reviews Approve Local ECs Automatic Approved

  3. Roles & Responsibilities of CREC and local ECs for local SAE & Deviation Review * Further actions may be required e.g. site visit, suspension of REC approval etc. PI/Sponsor submit local SAEs, Deviation & Violation Local EC * Reviews Other ECs * Make Decision If affects safety and welfare of other subjects CREC

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