Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
QUALITY ASSURANCE / IMPROVEMENT PROGRAM 1. OBJECTIVES a) Outline procedures and responsibilities for the Quality Assurance/Improvement (QA/QI) program at the Atlanta VA b) The QA/QI Program identifies and corrects deficiencies on an ongoing basis c) Provide ongoing training and education to research staff in ethical principles and proper research conduct 2. RESPONSIBILITIES a) The Principal Investigator is responsible for ensuring that research studies are conducted in compliance with federal regulations and institutional policies b) Ensures the quality and integrity of data when conducting human research studies c) Ensures regulatory compliance with VA policies and procedures d) Ensures that all study staff adheres to the study protocol for quality and consistency e) Makes study files accessible to the Research Compliance Officer (RCO) for review when conducting QA assessments or assessing non-compliance issues 3. PROCEDURES a) Investigator and study staff should self–assess their study performance prior to QA Assessment visit b) QA forms are available at: www.atlaref.org for research & drug/device studies c) The Research Compliance Officer (RCO) will schedule visits randomly or on an as needed basis to assess study performance d) The PI and Research Coordinator will be notified of the QA visit in advance in order to prepare properly e) QA Assessment visit duration may vary depending on findings or the study complexity f) Makes study files accessible to the Research Compliance Officer (RCO) for review when conducting QA assessments or assessing non-compliance issues g) All study documents must be available to the RCO to review upon scheduled visit. Items reviewed will include the Regulatory Study Binder and the following documents: I. Approved Protocol II. Original and revised Informed Consent Forms (if any) III. IRB Submission and R&D Committee Forms IV. IRB and R&D Committee approval letters 06-17-08 V. VI. VII. VIII. IX. X. XI. XII. Enrollment log Modifications (amendments) SAE Reports Continuing Review (renewals) Case Report Forms/ Data Collection Forms Source Documents Study staff log and training records Documentation verification of the informed consent discussion and research encounters XIII. Sponsor Correspondence (if applicable) h) After initial review, the RCO will meet with the study coordinator (and PI if necessary) to discuss discrepancies, findings, and to make study performance improvement recommendations i) The QA assessment form information is verified with the Emory IRB and R&D databases to confirm accuracy and ensure consistency of information j) If the study involves drugs, the Research Pharmacist will complete the Investigational Drug section and notify the RCO of any discrepancies k) Once the assessment is completed, a written summary will be sent to the PI and Research Coordinator l) The PI or designee will be responsible for clarifying any pending issues and for replacing any missing documents in the study binder m) If a non-compliance issue is discovered during the visit, the RCO generates a written report for the Non-Compliance Review Committee (NCRC) n) The NCRC will convene a meeting face to face or via teleconference to discuss the issue o) The NCRC sends a written report to the IRB with the recommended course of action. Some of the findings requiring action are: I. II. III. IV. V. VI. VII. Missing documents Discrepancies in study information Altered documents Poor Data collection or falsification Failure to follow protocol-required instructions Protocol violations Use of an unapproved Informed Consent Form or lack of subject signature or altered consent forms VIII. Failure to obtain written consent prior to initiating study activities IX. Failure to report Serious and Unexpected Adverse Events p) The IRB will assess the NCRC report and other evidence and determine whether the non-compliance is serious or ongoing q) The IRB will issue a report with its findings 06-17-08 r) The PI is required to send a written response no later than 30 days after the date of the letter. The response time may be shorter depending on the nature of non-compliance. s) The Chief Research Service, IRB Chair, and the R&D Committee Chair will also receive copies of the correspondence. t) 06-17-08 Reporting to the Office of Research Oversight (ORO), Office of Human Research Protection (OHRP), Food and Drug Administration (FDA), and/or the Atlanta VA Quality Management Department, respectively may be required.