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1. 2012 CTMB Audit Guidelines
... ... 7 3.2 Types of Visits and Frequency ... 7 3.3 ... Accountability of Investigational Agents and Pharmacy Operations .... 17 5.3.1 ... by an authorized individual AUTHORIZED PRESCRIPTION(S) Compliance Non-Compliance ...
Terms matched: 3  -  Score: 367  -  26 Jul 2018  -  URL: https://ctep.cancer.gov/initiativesprograms/docs/ETCTN_Monitoring_Guidelines.pdf
2. CTMB ETCTN Monitoring Guidelines
... . 9 3.2 Types of Visits and Frequency.... 9 3.3 ... Accountability of Investigational Agents and Pharmacy Operations.... 21 5.3.1 Control ... secure area without supervision AUTHORIZED PRESCRIPTION(S) Compliance Non-Compliance ...
Terms matched: 3  -  Score: 335  -  22 Sep 2021  -  URL: https://ctep.cancer.gov/branches/ctmb/clinicalTrials/docs/ctmb_etctn_guidelines.pdf
3. Summary of Changes to ETCTN
... called for an annual site visit to each investigator, had ... Appendix 2 – Worksheet for Pharmacy Review Appendix 3 – Worksheet ... maintained [DELETED] AUTHORIZED PRESCRIPTION(S) RETURN OF ...
Terms matched: 3  -  Score: 203  -  22 Sep 2021  -  URL: https://ctep.cancer.gov/branches/ctmb/clinicalTrials/docs/etctn_summary_of_changes.pdf
4. PART 1: Description of the Program and Its Policies
... follows: (1) Visit by Group Leadership to CTEP ... the three (regulatory, pharmacy, and patient care) ... investigational agent development program. Over the intervening years, the ...
Terms matched: 3  -  Score: 157  -  14 Oct 2009  -  URL: https://ctep.cancer.gov/initiativesPrograms/docs/coopgrpguidelines.pdf
5. A Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by CTEP, DCTD, NCI
... of performance should include site visits by investigators from the lead ... • PMB policy allows centralized pharmacies to receive study agents for ... to local satellite institutions and affiliated investigators who are registered with ...
Terms matched: 3  -  Score: 142  -  10 Mar 2014  -  URL: https://ctep.cancer.gov/investigatorResources/docs/InvestigatorHandbook.pdf
6. summary_of_changes.pdf
... called for an annual site visit to each investigator, had ... 2 – Audit Worksheet for Pharmacy Review Appendix 3 – Audit ... maintained [DELETED] AUTHORIZED PRESCRIPTION(S) RETURN OF ...
Terms matched: 3  -  Score: 109  -  31 Aug 2021  -  URL: https://ctep.cancer.gov/branches/ctmb/clinicalTrials/docs/summary_of_changes.pdf
7. February 2011 page 1
... Maybe people who work in pharmacies or developed by Celgene and ... site that includes thalidomide vials over the product's shelf life. ... @mail.nih.gov Patient Page Patient pill diaries can be a drama ...
Terms matched: 3  -  Score: 81  -  31 Jan 2011  -  URL: https://ctep.cancer.gov/branches/pmb/inside_pmb/feb2011.pdf
8. December 29, 1998
... time of the next scheduled visit (i.e. Diary Cards) ... procedures to allow the Dispensing Pharmacy to ship oral investigational agents ... have another individual pick-up the prescription for the subject. The ...
Terms matched: 3  -  Score: 81  -  28 Apr 2021  -  URL: https://ctep.cancer.gov/content/docs/CTEP_Oral_IND_Agent_Shipments.pdf
9. May 2010 page 1
... job in an investigational drug pharmacy or the first year, ... have time to do it over! And that time-saving practice ... minimum? Do not flush prescription drugs down the toilet or ...
Terms matched: 3  -  Score: 61  -  23 Apr 2010  -  URL: https://ctep.cancer.gov/branches/pmb/inside_pmb/may2010.pdf
10. Common Terminology Criteria for Adverse Events (CTCAE)
Adverse Event Reporting
... --- (including over the counter medications) Definition ... To expel gas noisily from the mouth. Navigational Note: ... ; Life-threatening Death nonprescription analgesics prescription analgesics hospitalization or intervention consequences ...
Terms matched: 3  -  Score: 54  -  23 Feb 2018  -  URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf
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