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CTSA Institution

Oregon Health & Sciences University

Disclaimer Please cite the appropriate authors/contacts when using or adapting these materials.
Acknowledgment Sponsored by OHSU Cancer Institute and Oregon Health & Science University, Oregon Clinical & Translational Research Institute (OCTRI)
Contacts Kathryn G. Schuff, MD, Associate Professor, Endocrinology; Director, Research Support and Services
Format PDF
URL Attachment
Materials Provided PowerPoint Presentation
Title Study Coordinator Education Series: Essential Regulatory and Source Documents” / “Regulatory Files ;Quality Assurance Auditing for Cancer Protocols
Topics Description This is 74 slide PowerPoint? presentation addresses three areas. Covers in detail how to maintain Essential Documents according to 21 CFR 312.62 Investigator recordkeeping (Record retention for Drug Studies); 21 CFR 812.140 (G) Records (a) Investigator records (Device Studies); FDA cites ICH Guidelines “Good Clinical Practices.” Explains source documents such as Case Reports Forms (CRFs); Consent Forms; Patient History; Medical charts; Laboratory/Pathology Reports; Ancillary reports (ECG, Scans, chest x-rays); Informed Consent Form (ICF) and HIPAA. Explains Source Documents, which is the first place data is recorded. Addresses how to properly input information in Case Report Forms (CRFs), and covers the audit process, how often, what is being reviewed, possible outcome and the process if the findings are not as they should be.

Comments: Good presentation covering regulatory aspects of keeping good research records of a study.

Keywords Adverse Events; Analyzing and Implementing Research; Ancillary Oversight Committee;
Approval Process; Assents Consent; Audit, Billing; Case Histories; Consent; Corrections to Study Records; CRQs (Continuing Review Questionnaires); Data Collection Forms; Document Corrective Actions; DSMC (Data and Safety Monitoring Committee); DSMP (Data and Safety Management Plan); Essential Documents; Exclusion Criteria; FDA; Financial Files; Good Clinical Practices; HIPAA; Inclusion Criteria; Industry; Informed Consent; Investigator Initiated Research; IRB Submission; IRQ (IRB Initial Review Questionnaire; Laboratory/Pathology Reports; Medical Charts; Medical Records; Modification; Monitoring; Nursing Summary; Operational; Patient History Documents; Protocols; Quality Assurance Auditing; Regulatory; Regulatory Binder; Regulatory Documents; Retention; Source Documentation; Statistician; Study Coordinator; Writing and Obtaining Informed Consent
See Also

Topic Data Acquisition Management Sharing and Ownership, Animal Welfare, Publication Practices and Responsible Authorship, Other
Topic revision: r4 - 12 Jun 2009 - 17:41:00 - NancyHills
ResearchEthics.Regulatory_and_Source_Docs_Regulatory_Files_QA_Auditing_for_Cancer_Protocols moved from ResearchEthics.RegulatoryandSourceDocsRegulatoryFilesQAAuditingforCancerProtocols on 12 Jun 2009 - 22:41 by NancyHills - put it back
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