Ensuring Drug Accountability Compliance with IRT

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Ensuring Drug Accountability Compliance with IRT
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Ensuring Drug Accountability Compliance with IRT

• Drug Accountability of the Investigation
  Medication begins from the selection of location
  for its storage. Issues with drug accountability
  are major and the majority of warning letters
  from regulators are a result of this. Major
  delays are faced by sites for non-conformity and
  it often leads to non-acceptance of trial data.
  Drug accountability is of utmost importance and
  it is the clinical investigator who remains
  responsible for the entire process taking place
  at the clinical site. If the supplies are
  controlled substances then more attention shall
  be needed from the Investigator in terms of its
  storage and disposition. IRT systems allow in
  streamlining such processes by keeping a single
  source of data and hence the process of Drug
  Accountability tracking becomes easier.
• Paper-based Drug Accountability Challenges
• It is the complexity surrounding the paper-based
  systems that makes them more prone to errors.
  Drug accountability shall be maintained at
  sponsor level and site level. The Investigational
  medication documented as shipped should reconcile
  with the documentation of used and unused. The
  Drug Accountability at site begins once an
  investigational drug reaches the site. Records
  need to be maintained and staffs need to confirm
  that the contents that have been shipped match
  its previous record. The authorized person needs
  to put his signature with date after thorough
  verification. Once these have been completed, the
  investigational drug needs to be stored securely
  maintaining the standards specified in the
  protocol. Entire details need to be updated in
  the drug accountability log and with the
  commencement of trials drug dispensing records
  are to be updated in writing in multiple
  documents.

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