Study Medication and The Study Medication Accountability Log

Any study medication (SM) being used in clinical research must be strictly and completely accounted for to ensure participant compliance and trial data integrity. medication-15966641

Study Medication accountability includes keeping records of:

  • the receipt and inventory of the drug,
  • storage of drugs,
  • temperature monitoring,
  • dispensing of drugs, and
  • return or disposal of the drugs.

The storage of the SM should be:

  • in a secure temperature monitored location with access limited to essential research personnel
  • temperature logged
  • only be used for participants

Responsibilities:

It is the responsibility of the Qualified Investigator (QI) to ensure accountability of the SM; however, this task can be delegated to a qualified person (eg pharmacist). The QI must ensure that the delegated team member is trained and understands the procedures necessary to maintain drug accountability and follows the trial protocol.

The Study Medication Accountability Log

The drug accountability log is an important tool to ensure accurate accountability of the study medication used in the trial.

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The log should be used to record the following information:

  • Treatment Number
  • Lot Number
  • Expiry date (yyyymmdd)
  • Study Subject ID
  • Date dispensed (yyyymmdd)
  • Initials of the individual dispensing the study medication

Upon return of each bottle, record the following:

  • Bottle returned
  • Date the bottle was returned (yyyymmdd)
  • The number of pills returned
  • Initials of the delegated individual receiving the bottle

Expired or unused SM:

  • should be destroyed at the site in accordance with appropriate procedures for destruction of investigational products
  • include the date of destruction in the Study Medication Accountability Log.

It is important to maintain through records that demonstrate SM management, as these records are subject to inspection during an audit or inspection.  Please note only those individuals assigned the above listed tasks on the Task Delegation Log should complete them.  

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