Audit Preparation for te CCOP Division of Cancer 审核准备CCOP分癌症.pptVIP

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2018-06-19 发布于福建
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Audit Preparation for te CCOP Division of Cancer 审核准备CCOP分癌症.ppt

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Audit Preparation for te CCOP Division of Cancer 审核准备CCOP分癌症

Audit Preparation 101 for the CCOP Regulatory Preparation Keep Current – start audit preparation with the initiation of a new clinical trial Organize clinical trial regulatory books by: IRB (if you use multiple IRBs) Cooperative Groups Protocol numbers Tab and color code for: Initial Approval Updates, Amendments SAEs Continuing Reviews Regulatory Preparation continued Submit new information to IRBs right away. (Check Cooperative Group websites at least monthly) Audit your IRB information from Cooperative Groups for open and closed to accrual protocols at least every two months. Permanently close trials should be audited prior to closure. Audit satellite sites at least every two months for their submissions to IRB. Regulatory continued Look for activity since you last audited. Document date you audited last. Review letters from IRB immediately Make sure information and wording of letters is correct. Make sure that all SAEs submitted are listed in the acknowledgement letter. Attend PRIMER, if possible, to gain perspective what is expected of IRBs Data Management preparation Start off tabbing shadow charts for audit when the chart is initially being put together. Color code tabs: Source documentation for eligibility criteria Chemotherapy cycles that include all supporting data for those cycles Progress notes Labs Tests Chemotherapy administration records SAE source documentation Data Management preparation Tab follow up information in separate color. Write 3mo, 6 mos, annual, etc on tab Highlight source documentation used to support information recorded on the CRFs/data management forms. Attend Cooperative Groups audit preparation classes. Drug AccountabilityIf you do not have a pharmacist If possible have one CRA responsible for: Drug inventory monthly. Filing and checking packing slips against receivables and what was ordered. Ordering drug and drug disposing. Logging in and out of drug to CRAs/nurses. Responsible for tracking satellite site DARFs. * *