GxP Lifeline

Ensuring Drug Accountability in Clinical Trials


Drug accountability in clinical trials is pretty much what you’d expect. It holds the organizations and people involved in the trial accountable for how they handled the drug being used. Improper drug accountability places the entire clinical trial at risk. Pharmaceutical companies, and regulators, can’t be assured the results of the trial are accurate if there’s information missing from the drug accountability record. This is a critical part of the requirement from 21 CFR Part 312 to maintain adequate records of the disposition of the drug. In some cases, this comes down to simple math. If your records show you provided a subject with 40 pills and he or she somehow took 42, that’s an issue. That might be simple math but ensuring proper drug accountability is far from simple. It requires forethought and consistency to be done properly.

Components of the Drug Accountability Record

Part of that forethought is determining what needs to be recorded. Drug accountability records should include:

  • Drug name.
  • Lot number.
  • Expiration date.
  • The amount of drug received, used, returned, or thrown away.
  • The amount of drug left.

Your records may require additional information, depending on the type of trial and type of drug. For example, if the drug requires preparation and is administered on site, the record should include the date and time it was given. If it’s prepared and the subject is a no-show, sites need to record if it was destroyed. If the drug is refrigerated, temperature needs to be recorded.

Once you know what information needs to be included, ensuring that information is recorded is the next step.

Documentation and Training

Training is vital, regardless of how your site will be recording the information. However, when the documentation is on paper, training can be more of a challenge. Because there’s no way to ensure that someone fills out all the fields on a physical paper, you will commit a significant amount of time to explaining how to mitigate common mistakes with handwritten records. One example is unclear date formats. Does 3/4/21 mean March 4 or April 3? Issues like this frequently happen with paper documentation.

Switching to an electronic format gives you the control to ensure mistakes created by illegible handwriting or differing formats don’t happen. We’ve all filled out online forms that require dates in certain formats or that have required fields. The same concept applies in electronic drug accountability records. For example, depending on the program you use, it’s possible to require specific fields to add up before a user can proceed. The sum of the amount of drug used, returned, thrown away, and left should equal the amount of drug received. Anything else is problematic and needs to be addressed with corrective action.


Exactly how you set up drug accountability records in your clinical trial will vary depending on the drug being used. The important thing to remember is that however you choose to manage these records, it needs to be planned before the trial begins. Thorough standard operating procedures (SOPs), good training, and vigilance will ensure accurate records and minimal issues. Having tools like electronic documents will improve efficiency and reduce your chances of making data entry errors. Not only will this keep the trial from running into problems during an inspection, it will also ensure more accurate, trustworthy results from the trial.


Sarah Beale is a content marketing specialist at MasterControl in Salt Lake City, where she writes white papers, web pages, and is a frequent contributor to the company’s blog, GxP Lifeline. Beale has been writing about the life sciences and health care for over five years. Prior to joining MasterControl she worked for a nutraceutical company in Salt Lake City and before that she worked for a third-party health care administrator in Chicago. She has a bachelor’s degree in English from Brigham Young University and a master’s degree in business administration from DeVry University.

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