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

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Clinical Investigator SOPs � FDA Guidance for Industry ‘Protecting the Rights, Safety, and Welfare of Study Subjects ‐ Supervisory Responsibilities of Investigators’ published May2007 � Correcting problems identified by study personnel, outside monitors or auditors, or other parties involved in the conduct of a study � Documenting the performance of delegated tasks in a satisfactory manner and, where appropriate, verifying findings (e.g., observation of the performance of selected assessments or independent verification by repeating selected assessments) � Ensuring that the consent process is being conducted in accordance with 2 1 CFR Part 50 and that study subjects understand the nature of their participation, risks, etc. � Ensuring that information in source documents is accurately captured on the Case Report Forms � Dealing with data queries and discrepancies identified by the study monitor � Ensuring study staff comply with the protocol, adverse event assessment and reporting, and other medical issues that arise during the course of the study.
Clinical Investigator SOPs � Investigator and Staff Qualifications and Training � Financial Disclosure and Certification � IRB Evaluation and Submissions � Subject ICF/HIPAA Process � Subject Qualification Review � Source Documentation � Case Report Form Transcription and Query Administration � Adverse Events and Serious Adverse Events � Investigational Product Management � Monitoring Visits � External Audits and Regulatory Authority Inspections � Record Retention and Archive
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 8 and 9: Definitions �Terminology used in
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 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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