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 | |
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 |
I | Attachment | Action | Size | Date | Who | Comment |
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OHSUCoordinatorTraining_-_Reg_Binder_and_Source_Binder.pptx | manage | 1484.3 K | 02 Apr 2009 - 09:57 | NancyHills |