samplecqmp - DAIDS Bethesda MD USA APPENDIX Sample Clinical...

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DAIDS Bethesda, MD USA APPENDIX Sample Clinical Quality Management Plan (CQMP) Approval Date: 26 FEB 2010 Effective Date: 26 MAR 2010 No.: DWD-POL-CL-009.03A1 Page 1 of 4 Sample Clinical Quality Management Plan (CQMP) (SAMPLE ONLY. The template below is provided for your convenience as an example of how this information may be provided. Frequency/percentage of reviews and types of tools/reports used should be selected to meet the specific needs of the clinical research site.) Site Number_______ Site Name_________________________ Section I: Responsibility John Smith, MD, Principal Investigator, is responsible for the Clinical Quality Management Plan at __________. Mary Brown, RN, Study Coordinator, has been designated by Dr. Smith to be responsible for the implementation of the Clinical Quality Management Plan. Section II: Key Quality Control (QC) Staff Bill Thomas, Data Manager, is responsible for the day-to-day QC activities, with support from other data personnel. Section III: Key Quality Assurance (QA) Staff Sara Johnson, RN, is responsible for QA activities at the site. Section IV: QM Activities and Tools Quality Control (QC): The following activities and tools will be utilized in the QC process: 1. Error correction reports from the data management center will be reviewed by the Data Manager, who will immediately bring any errors identified to the attention of the appropriate site staff for correction. Errors will be corrected within 2 business days of identification. 2.
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samplecqmp - DAIDS Bethesda MD USA APPENDIX Sample Clinical...

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