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Handling Investigational Product at Clinical Site

Introduction to online course discussing investigational products and how to maintain at sponsor and investigator sites.

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Handling Investigational Product at Clinical Site

  1. 1. Handling Investigational Drug Products (Introduction) Instructor: Sarah Wilson, MS, CCRP My philosophy: I accept the things I cannot change; I choose to change whatever I can; And I pray for wisdom to know the difference . Reinhold Niebuhr
  2. 2. Handling Investigational Drug Products <ul><li>Note: The overall process for handling IP described in these lessons should be considered when working with biologics, medical device and combination product clinical trials. For simplicity, this course focuses mostly on drug trials. </li></ul>Biologics - A preparation, such as a drug, a vaccine, or an antitoxin, that is synthesized from living organisms or their products and used as a diagnostic, preventive, or therapeutic agent. Combination Products - A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity.
  3. 3. Handling Investigational Drug Products <ul><li>Introduction </li></ul><ul><li>Common Terms </li></ul><ul><li>Labeling Requirements </li></ul><ul><li>Responsibilities </li></ul><ul><li>Storage and Environmental Logs </li></ul><ul><li>Compliance and Accountability </li></ul><ul><li>Control of Investigational Products (e.g. drugs) </li></ul>
  4. 4. Handling Investigational Drug Products <ul><li>An investigational drug is the pharmaceutical form of an active ingredient generally tested in a clinical trial and used for an unapproved indication, or used to gain further information about an approved product. </li></ul>
  5. 5. Handling Investigational Drug Products <ul><li>Sponsor </li></ul><ul><li>Responsibilities </li></ul>
  6. 6. Handling Investigational Drug Products <ul><li>The sponsor oversees the manufacture, packaging and shipment of investigational drug. </li></ul><ul><li>Audit trails are important for showing </li></ul><ul><ul><li>When drug was made. </li></ul></ul><ul><ul><li>When drug was packaged. </li></ul></ul><ul><ul><li>Where and under what conditions drug was stored. </li></ul></ul><ul><ul><li>When drug was shipped/received. </li></ul></ul><ul><ul><li>When drug was returned. </li></ul></ul><ul><ul><li>When drug was destroyed. </li></ul></ul>
  7. 7. Handling Investigational Drug Products <ul><li>Many sponsors use an interactive voice response system (IVRS) for tracking drug product. </li></ul><ul><li>IVRS is programmed to match the sponsors clinical trial requirements. </li></ul><ul><li>Helps sponsor maintain the blind. </li></ul><ul><li>Each investigator’s name is entered. </li></ul><ul><li>Each subject is registered and followed throughout the clinical trial. </li></ul>
  8. 8. Handling Investigational Drug Products <ul><li>The frequency of drug distribution is entered for each subject. </li></ul><ul><li>The total amount of drug distributed to investigators is available throughout the trial. </li></ul><ul><li>Medication ID numbers are matched to each subject receiving drug. </li></ul><ul><li>The IVRS log serves as a partial drug accountability source for the source. </li></ul>
  9. 9. Handling Investigational Drug Products Investigators Responsibilities
  10. 10. Handling Investigational Drug Products <ul><li>Requirements at investigator’s site include </li></ul><ul><ul><li>Drug inventory records or logs. </li></ul></ul><ul><ul><li>Drug dispensing records per subject. </li></ul></ul><ul><ul><li>Drug return per subject. </li></ul></ul><ul><ul><li>Drug amount used per subject. </li></ul></ul><ul><ul><li>Environmental monitoring logs. </li></ul></ul><ul><ul><li>Security of investigational product. </li></ul></ul><ul><ul><li>Drug amount returned to sponsor or destroyed by site personnel. </li></ul></ul>
  11. 11. Handling Investigational Drug Products <ul><li>Documentation Requirements !! </li></ul>
  12. 12. Handling Investigational Drug Products <ul><ul><li>Drug shipments (sponsor) </li></ul></ul><ul><ul><ul><li>Labeling </li></ul></ul></ul><ul><ul><li>Drug receipts (investigator) </li></ul></ul><ul><ul><ul><li>Date </li></ul></ul></ul><ul><ul><ul><li>Amount </li></ul></ul></ul><ul><ul><li>Drug Storage (sponsor and investigator) </li></ul></ul><ul><ul><ul><li>Temperature/humidity </li></ul></ul></ul><ul><ul><ul><li>Security </li></ul></ul></ul>
  13. 13. Handling Investigational Drug Products <ul><ul><li>Drug distributions (sponsor and investigator) </li></ul></ul><ul><ul><ul><li>Quantities </li></ul></ul></ul><ul><ul><ul><li>Subject </li></ul></ul></ul><ul><ul><li>Drug return (investigator) </li></ul></ul><ul><ul><ul><li>Compliance </li></ul></ul></ul><ul><ul><ul><li>Reconciliation </li></ul></ul></ul><ul><ul><li>Drug destruction (sponsor) </li></ul></ul><ul><ul><ul><li>Destruction certificate </li></ul></ul></ul>
  14. 14. Handling Investigational Drug Products <ul><li>Two common ways of maintaining these records are </li></ul><ul><ul><li>Paper files </li></ul></ul><ul><ul><li>Electronic files </li></ul></ul><ul><li>Retention requirements remain the same, no matter which means for documentation is used. </li></ul>
  15. 15. Handling Investigator Drug Products <ul><li>This is a quick overview of what to expect in Lessons 1-5 </li></ul><ul><li>Complete all assignments at </li></ul><ul><li>See you in chat!! </li></ul><ul><li>HAVE A QUALITY DAY ! </li></ul>