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Pearls of Wisdom: Pharmacy Debra Herzan, RN, BSN, OCN, CCRP Alliance Clinical Trials Auditor Alliance, Chicago Office

Pearls of Wisdom: Pharmacy · Pearls of Wisdom: Pharmacy ! Debra Herzan, RN, BSN, OCN, CCRP ! Alliance Clinical Trials Auditor ! Alliance, Chicago Office . Pharmacy: Common Problems

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Page 1: Pearls of Wisdom: Pharmacy · Pearls of Wisdom: Pharmacy ! Debra Herzan, RN, BSN, OCN, CCRP ! Alliance Clinical Trials Auditor ! Alliance, Chicago Office . Pharmacy: Common Problems

Pearls of Wisdom: Pharmacy

l  Debra Herzan, RN, BSN, OCN, CCRP l  Alliance Clinical Trials Auditor l  Alliance, Chicago Office

Page 2: Pearls of Wisdom: Pharmacy · Pearls of Wisdom: Pharmacy ! Debra Herzan, RN, BSN, OCN, CCRP ! Alliance Clinical Trials Auditor ! Alliance, Chicago Office . Pharmacy: Common Problems

Pharmacy: Common Problems

l  NCI Drug Accountability Record Form (DARF) not correctly filled out.

l  Unable to track study supplied agents.

l  Inadequate storage or security of study agent.

Page 3: Pearls of Wisdom: Pharmacy · Pearls of Wisdom: Pharmacy ! Debra Herzan, RN, BSN, OCN, CCRP ! Alliance Clinical Trials Auditor ! Alliance, Chicago Office . Pharmacy: Common Problems

NCI Drug Accountability Record Form (DARF) not correctly filled out

l  Pearl: Refer to Pharmaceutical Management Branch (PMB) website for guidelines and video tutorials: http://ctep.cancer.gov/branches/pmb/agent_management.htm

Page 4: Pearls of Wisdom: Pharmacy · Pearls of Wisdom: Pharmacy ! Debra Herzan, RN, BSN, OCN, CCRP ! Alliance Clinical Trials Auditor ! Alliance, Chicago Office . Pharmacy: Common Problems
Page 5: Pearls of Wisdom: Pharmacy · Pearls of Wisdom: Pharmacy ! Debra Herzan, RN, BSN, OCN, CCRP ! Alliance Clinical Trials Auditor ! Alliance, Chicago Office . Pharmacy: Common Problems
Page 6: Pearls of Wisdom: Pharmacy · Pearls of Wisdom: Pharmacy ! Debra Herzan, RN, BSN, OCN, CCRP ! Alliance Clinical Trials Auditor ! Alliance, Chicago Office . Pharmacy: Common Problems

Unable to track study supplied agents l  Pearl: Keep all records!

Page 7: Pearls of Wisdom: Pharmacy · Pearls of Wisdom: Pharmacy ! Debra Herzan, RN, BSN, OCN, CCRP ! Alliance Clinical Trials Auditor ! Alliance, Chicago Office . Pharmacy: Common Problems
Page 8: Pearls of Wisdom: Pharmacy · Pearls of Wisdom: Pharmacy ! Debra Herzan, RN, BSN, OCN, CCRP ! Alliance Clinical Trials Auditor ! Alliance, Chicago Office . Pharmacy: Common Problems
Page 9: Pearls of Wisdom: Pharmacy · Pearls of Wisdom: Pharmacy ! Debra Herzan, RN, BSN, OCN, CCRP ! Alliance Clinical Trials Auditor ! Alliance, Chicago Office . Pharmacy: Common Problems

Inadequate storage or security of study agent

l  Pearl: Refer to PMB Policy & guidelines for Accountability and Storage of Investigational Agents

Page 10: Pearls of Wisdom: Pharmacy · Pearls of Wisdom: Pharmacy ! Debra Herzan, RN, BSN, OCN, CCRP ! Alliance Clinical Trials Auditor ! Alliance, Chicago Office . Pharmacy: Common Problems

Pearls of Wisdom: Pharmacy

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