Terri P. Kelly, RN, MSQA, CQA President and Principal ... - FDA News

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Responsibility

�Can be combined with Procedure

Steps

�Who is assigned responsibility for

what tasks

�Who has overall responsibility to

oversee compliance to SOP

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Definitions �Terminology used in SOP �SOPs are training tools for new employees �Copy definitions from ICH GCP E6

Responsibility �Can be combined with Procedure Steps �Who is assigned responsibility for what tasks �Who has overall responsibility to oversee compliance to SOP

Page 1 and 2: Terri P. Kelly, RN, MSQA, CQA Presi
Page 3: Procedural Documents
Page 6 and 7: Purpose �Reason for SOP �This S
Page 10 and 11: Procedure Steps �Step‐by‐step
Page 12 and 13: References • Listing of Regulatio
Page 14 and 15: Which Document Level? �Oracle Cli
Page 16 and 17: Sponsor/CRO Clinical SOPs � Clini
Page 18 and 19: Sponsor Warning Letters •[21 CFR
Page 20 and 21: Clinical Investigator SOPs � FDA
Page 22 and 23: CI Warning Letters • [21 CFR 312.
Page 24: CI Warning Letters � [21 CFR 312.

Terri P. Kelly, RN, MSQA, CQA President and Principal ... - FDA News

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