Opposing Forces in eTMF Management: How improvements can cause collateral damage

June 9, 2014

  • eTMF Resources

We have all heard of the Law of Unintended Consequences: actions always have effects that are unanticipated or unintended.  This is an important consideration when working to optimize your eTMF processes. You might initially think: “How could it be bad to improve my document quality… or TMF completeness… or timeliness in processing?”  In many cases, improvements are very worthwhile.  However,

Opposing Forces in eTMF Managementan organization needs to ensure that any effort to improve one of these key metrics doesn’t result in unacceptable degradation in other areas Each of these areas has a direct impact on the others.  For example:  a focus on timeliness may result in decreased focus on quality that is only discovered later.    Attempts to improve quality may cause bottlenecks that impact completeness, timeliness or both.    And a rush to reach a desired state of completeness (such as that needed for an inspection) often has a negative impact on quality.All of this underscores the importance of having a well-organized and properly governed metrics program.    The key steps of this program would be similar to traditional CAPA and include


  1. Establishing target thresholds for key Critical to Quality (CTQ) measurements related to eTMF (such as maintaining all trials at 96% TMF completeness or higher).
  2. Making it someone’s responsibility to monitor the identified CTQ measurements, and to analyze them across dimensions.   These dimensions would certainly vary among organizations, but probably include analysis by country, document origin (such as scan center), TMF reference model zone, CRO partner, and much more.   This may reveal that the non-compliance is not in fact across the board, but attributable to a specific partner, much more common in certain countries, etc.
  3. Defining a path to escalate and address the identified issues and bottlenecks.  In some cases, this may be straightforward – servicing or replacing scanners that routinely skip pages, for example.  But take a recent example where a sponsor’s most common cause of QC rework was incorrect document type.  Was this because users weren’t trained to identify documents correctly, the taxonomy itself was unclear, or it just wasn’t realistic to expect people to be able to identify many hundreds of document types?    The root cause is important, but even after it is known the correction needs to be thought out.  For example, if users struggle to identify hundreds of document types, making them consult voluminous work instructions may fix the quality issue, but impact timeliness and completeness.  Maybe there is another way – help directly in the application or a quick to use web site, identification of the eTMF document type on the cover page, or some other solution.
  4. Monitoring the results of the remediation.    Did it actually address the problem?  Does it appear to have caused undesired side effects in other areas?

Following a well-designed process will greatly assist an organization in harnessing the true power of an eTMF metrics program and avoid the law of unintended consequences.