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Kim McConnell, PharmD, CCRP CCOP Annual Investigators Meeting Houston, Texas March 3, 2011.

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Presentation on theme: "Kim McConnell, PharmD, CCRP CCOP Annual Investigators Meeting Houston, Texas March 3, 2011."— Presentation transcript:

1 Kim McConnell, PharmD, CCRP CCOP Annual Investigators Meeting Houston, Texas March 3, 2011

2 To present and review regulations that apply to the maintenance, management and monitoring of Investigational doses To review milestones for an Investigational Protocol as they relate to Investigational doses To provide pointers for practical application of this information for the management and maintenance of Investigational inventory


4 Properly administer doses to enrolled Patients 21 CFR , ICH GCP Maintain complete documented accountability of inventory 21 CFR , ICH GCP Maintain proper storage conditions ICH GCP Return/Destroy all unused inventory as instructed 21 CFR Delegation of duties where applicable ICH GCP Document retention* 21 CFR , ICH GCP 4.9.5

5 Document retention* 21 CFR , ICH GCP Provide information on Investigational Product 21 CFR , 21 CFR312.50, ICH GCP 5.12 Proper delivery, packaging and labeling of Investigational Product 21 CFR , 21 CFR , 21 CFR 312.6, ICH GCP 5.13, 5.14 Proper instruction for use and maintenance of Investigational Product 21 CFR , 21 CFR , ICH GCP 5.14 Verification of proper usage of Product 21 CFR , ICH GCP 5.18 Provide safety information regarding product 21 CFR , 21 CFR , 21 CFR , 21 CFR312.56

6 Additional Federal Guidelines State Law Institutional Policy and Procedures Departmental Policy and Procedures


8 Site Activation Inventory Request and Receipt Maintenance of Supply Storage Dispensing Maintaining the Blind Expiration/Recall Study Monitoring Study Closeout

9 Supporting Documentation Requested IRB Approval Letter Policies and Procedures Destruction Policy Accountability Records Contact Information Unblinded Team Members

10 Determining Initial Supply Needs Number of Patients Dosing Schedule Blinding and Supply Presentation Study Specific Order Form Site Contact Information Protocol Number Protocol Title Quantity Needed Date Needed Turnaround Time

11 Documentation of Receipt Packing Slip Accountability Record Shipment Acknowledgement Recordkeeping

12 Storage Conditions and Monitoring Room Temperature Refrigerated Security Secure area with limited access Documentation

13 Methods for Preparation Proper Labeling Required components of labeling Blinded Presentation Verification of Doses and Dispensing Accuracy Confirmation of Kit Number/Treatment Recording of Information Record Retention

14 Requirements for Mail Out IND Status Permission to Mail Out Record Retention Requirements and Guidelines Federal Regulations 21 CFR , 21 CFR State Regulation Institutional Policies

15 Randomization Record Familiarity with Study Design and Schedule Identification of Blinded and Unblinded Personnel Access to Treatment Assignment Steps for Randomization Steps for Verifying Randomization

16 Notification Final Accountability Final Disposition Destruction vs Return to Supplier Documentation

17 Record Requests Count Review Discrepancies

18 Complete Accountability Final Disposition Documentation


20 REMEMBER THE PATIENT Organization of Records Knowing the Inventory Knowing the Protocol Randomization and Maintaining the Blind Maintaining Contact Asking Questions Documentation



23 Maintain a consistent filing system Include a copy of the treatment plan Include instructions for coverage Find a system that works


25 How is it supplied? How must it be taken? Appearance and Blinding Tear off Labels and Kit Numbers


27 Understand and be aware of the milestones and treatment plan throughout the Protocol Review for information as it pertains to inventory Storage Conditions Emergency Reassignment Unblinding Unused Medication


29 How does randomization work? Access and Procedures for Computerized Randomization How will this inventory be presented to the Patient? What is everyones blinding status on the Study Team?



32 REMEMBER THE PATIENT Know and understand the responsibilities of the Sponsor and Site Investigator Stay within the definition of local, state and Federal requirements Be aware of your resources Maintain perpetual, timely and accurate documentation Be familiar with the Protocol and the Product Maintain blinding If in doubt, ask


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