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1. CTMB_Auditor_Monitor_Training_Modules.pdf
... Auditor/Monitor Training Modules ____ 1. Introductory Module 2. Regulatory Module 3. Pharmacy Module 4. Patient Case Module 5. SAP& TSDV Module January 2019 Introductory ...
Terms matched: 1  -  Score: 311  -  14 Mar 2019  -  URL: https://ctep.cancer.gov/content/docs/CTMB_Auditor_Monitor_Training_Modules.pdf
2. 2012 CTMB Audit Guidelines
... the Regulatory Documentation Review .... 16 5.3 Review of Accountability of Investigational Agents and Pharmacy Operations .... 17 5.3.1 Control Dispensing Area/Pharmacy .... 18 5.3.2 Satellite Dispensing Area/Pharmacy ...
Terms matched: 1  -  Score: 141  -  26 Jul 2018  -  URL: https://ctep.cancer.gov/initiativesPrograms/docs/ETCTN_Monitoring_Guidelines.pdf
3. 2012 CTMB Audit Guidelines
... the Regulatory Documentation Review .... 16 5.3 Review of Accountability of Investigational Agents and Pharmacy Operations .... 17 5.3.1 Control Dispensing Area/Pharmacy .... 18 5.3.2 Satellite Dispensing Area/Pharmacy ...
Terms matched: 1  -  Score: 141  -  26 Jul 2018  -  URL: https://ctep.cancer.gov/initiativesprograms/docs/ETCTN_Monitoring_Guidelines.pdf
4. Investigational_Agent_Distribution.pdf
... PMB strongly recommends that all participating investigators at an institution use the same shipping (pharmacy) address by establishing a Primary Shipping Designee (PSD) with PMB (email ...
Terms matched: 1  -  Score: 19  -  23 Sep 2016  -  URL: https://ctep.cancer.gov/protocolDevelopment/requisition_agents/docs/Investigational_Agent_Distribution.pdf
5. ETCTN Regulatory Processing Information Sheet
... , statistics, protocol development, data management and administration, and regulatory and research pharmacy management. The clinical trials of the ETCTN must be conducted in accordance with the ...
Terms matched: 1  -  Score: 141  -  5 Jul 2016  -  URL: https://ctep.cancer.gov/initiativesPrograms/docs/ETCTN_Program_Guidelines.pdf
6. Inside PMB-May 2016
... return the old vial strength only when the new supply has been received in the pharmacy. Those sites that are still awaiting amendment approval from their local IRB may continue ...
Terms matched: 1  -  Score: 11  -  27 Apr 2016  -  URL: https://ctep.cancer.gov/branches/pmb/inside_pmb/may2016.pdf
7. reporting_errors_to_PMB.pdf
... What factors contributed to the occurrence of this incident? • Was a pharmacist or pharmacy personnel involved in the error? If so, is this pharmacist or pharmacy personnel ...
Terms matched: 1  -  Score: 29  -  18 Apr 2016  -  URL: https://ctep.cancer.gov/branches/pmb/faq/docs/reporting_errors_to_PMB.pdf
8. ETCTN Monitoring and Auditing Information Sheet
CTSU
... The three components of a study audit are: • IRB/Informed consent content review • Pharmacy and drug accountability; and • Patient case review 3.1 Types and Frequency of Audits ...
Terms matched: 1  -  Score: 19  -  3 Feb 2016  -  URL: https://ctep.cancer.gov/initiativesPrograms/docs/ETCTN_Audit_Monitoring.pdf
9. Preparing_Protocol_Documents.pdf
... New Roman Times New Roman Italic Times New Roman Bold Times New Roman Bold Italic Sans Serif Arial Arial Italic Arial Bold Arial Bold Italic Non proportional Courier New Courier New ...
Terms matched: 1  -  Score: 11  -  11 Dec 2015  -  URL: https://ctep.cancer.gov/protocolDevelopment/docs/Preparing_Protocol_Documents.pdf
10. Agent_Transfers_Handout.pdf
... is insufficient protocol supply to dispense or prepare a dose. 2. The control pharmacy or dispensing area relocates. 3. The responsible investigator at the site changes. ...
Terms matched: 1  -  Score: 12  -  2 Dec 2015  -  URL: https://ctep.cancer.gov/branches/pmb/drug_training_videos/Agent_Transfers_Handout.pdf
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