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Regulations/ICH E6(R3)/Actors & Services
Actors & Services · ICH E6(R3)

Actors & Services for ICH E6(R3).

This page maps the people and service routes around the regulation. It shows who needs which evidence view and where iFeed can support review, translation, training, or readiness work without overclaiming.

Source basis: ICH E6(R3) Guideline for Good Clinical PracticeUse: evidence-readinessBoundary: not legal advice
ICH E6(R3) TRACE E6(R3) PRINCIPLESANNEX 1 FINALGLOSSARY/DEFINITQUALITY BY DESIG
/ Actors

Different owners need different evidence views.

ICH E6(R3)
Actor 01

sponsor

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for ICH E6(R3).

Actor 02

investigator

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for ICH E6(R3).

Actor 03

CRO/vendor manager

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for ICH E6(R3).

Actor 04

clinical QA

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for ICH E6(R3).

Actor 05

data management

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for ICH E6(R3).

Actor 06

medical monitor

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for ICH E6(R3).

Actor 07

TMF/eTMF owner

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for ICH E6(R3).

/ Service fit

Where iFeed can help without overclaiming.

bridge work
Route 01

Source-to-evidence mapping

Convert source material into evidence objects, owners, gaps, and next actions.

Route 02

Checklist evaluation

Review completed readiness sheets and identify unclear or unsupported claims.

Route 03

Governance sprint

Create a practical two-week route for inventory, role mapping, evidence review, and update protocol.

Route 04

Training/workshop

Turn source reading into role-specific literacy and operational confidence.

Source anchors

Current public sources for ICH E6(R3).

official first

These links are the public source anchors for this workspace. Interpretation, checklists, and future assets should point back here before being reused outside iFeed.

Official ICH page

ICH Efficacy Guidelines page

Current · Official landing page for ICH efficacy guidelines including E6(R3).

open
Official guideline PDF

ICH E6(R3) Step 4 final guideline

2025-01-06 · Final Step 4 guideline text for principles and Annex 1.

open
Official EMA page

EMA ICH E6 scientific guideline page

2025-07-23 · EU regional implementation context for ICH E6(R3) Principles and Annex 1.

open
Official ICH draft / watch item

ICH E6(R3) Annex 2 draft

2024-11-06 · Draft Annex 2 source. Treat as watch item, not final implemented requirement.

open