ASK JEAN: Pharmacy Records in Clinical Trials – Drug Accountability Records

15 April 2021

The Chronicle Spring 2021 – by Jean Smart, Regulatory Affairs and Quality Officer, Clinical Trials BC


What drugs issued from our pharmacy need to have drug accountability records retained for a clinical trial?


Pharmacy Records that are retained for a clinical trial include at a minimum: clinical trial drug prescriptions, any calculations for clinical trial drug dispensing, drug accountability records and clinical trial drug storage logs. Additional records may be required if there are any noted restrictions on the packaging, instructions provided by the sponsor, change in location of the product (examples include: humidity controls, quarantine records, site transfer records from one storage place to another). Drug accountability record is just one aspect of a Pharmacy Record for a clinical trial.

Drug accountability focuses on the drug and includes: 

  • Date and Time of Arrival at the site
  • Quantity received
  • Condition of product upon receipt
  • Identification (lot number, batch)
  • Expiry date
  • Quantity dispensed (date, time and to where and whom)
  • Quantity returned to pharmacy by subjects or by the site clinic
  • Quantity and date of destruction or return to sponsor
  • Destruction certificate if applicable.

There are six instances of drug products that DO  require accountability records for a clinical trial.  They are described in the Canadian Food and Drug Regulations C.05.012 (c) and can be summarized as follows:

  • Drug Products that are listed in the Protocol and Clinical trial Application that do not have market authorization
  • Drugs Products that are listed in the protocol and Clinical trial application that have market approval BUT are used ‘off-label’ (for a use other than what it was approved for)
  • Comparator drugs, that do not have market authorization
  • Comparator drug with market authorization, BUT its labelling is changed (i.e., for blinding purposes)
  • Comparator drug, if it has market authorization, BUT it is used ‘off label’ (unless it was not considered to be investigational in the context of the clinical trial, based on the assessment of the application by Health Canada)
  • Any drug listed on Section 8 of the HC/SC form 3011 (by either the Brand or the Proprietary Name).

There are three categories of drug products that DO NOT require accountability records in the Pharmacy for a clinical trial:

  • Drugs that are for a Phase IV clinical trial
  • Comparator drug, if it has market authorization, is used ‘on-label’ and has not been changed in any way (including the labelling)
  • Rescue or concomitant medications, authorized for sale in Canada, that may be used ‘on- label’ or ‘off-label’ but are not the subject or focus of the clinical trial (they are support medications for clinical care)

Clinical trial drug accountability logs are essentially only required for drugs that are specifically listed as ‘clinical trial supply’ listed in the No Objection letter received after a Clinical Trial Application has been approved.

Helpful Reference documents on this subject:

  • Health Canada, “Notice to Stakeholders on the Investigational use of marketed Drugs in Clinical Trials. June 5, 2019.
  • Health Canada, Guidance for Clinical Trial Sponsors: Clinical Trial Applications, May 29, 2013.
  • Health Canada, Guidance 0100 Part C Division 5 of the Food and Drug Regulations, “Drugs for Clinical trials involving Human Subjects”, August 20, 2019.