Audit time! What you need to cover
Demonstrating compliance in clinical trials should be straightforward if the groundwork has been laid properly throughout the study. Here is how to make sure the most important areas are covered before an auditor arrives.
Knowing where inspections actually find problems is a useful place to start. A seven-year analysis of FDA Good Clinical Practice inspections supporting marketing applications, covering 2,836 inspections between 2017 and 2023, found that 81.2% resulted in No Action Indicated, 18.5% in Voluntary Action Indicated, and just 0.3% in the most serious Official Action Indicated classification. Encouragingly, most inspections go well. But among the inspections that did surface problems, two categories dominated everything else: adherence to the trial protocol, and adequacy of records, together accounting for well over half of all findings. Nearly everything below covers one or the other.
Run internal audits before anyone external does
The most reliable preparation for an audit is conducting your own first. Rotate staff through different aspects of conduct evaluation, develop a standard operating procedure for the review process, and approach it with genuine objectivity: what would someone coming in from outside find?
Auditors are looking to confirm that:
- Staff understand their individual responsibilities
- Training is current and documented
- Every intervention has been properly authorised and verified
- Participant safety has been considered at every stage
- There are no gaps or inconsistencies that the team is unaware of
Finding problems yourself before an audit allows you to address them without scrutiny. Discovering them during an audit does not.
Keep delegation logs updated
Every team member involved in a study needs documented authorisation for the specific tasks they perform, whether that is obtaining consent, administering a treatment, or conducting participant interviews. Management roles also require documentation.
An outdated delegation log is one of the most common audit findings and one of the easiest to avoid. It's a textbook example of the "adequacy of records" category that the analysis above found behind nearly a third of all downgraded inspection outcomes. Review it regularly and update it whenever responsibilities change.
Maintain current training records
Training documentation needs to be accurate, particularly for higher-risk studies where participant safety is the primary concern. The principal investigator is ultimately responsible for ensuring delegation is appropriate and that competency is verified.
Useful records to maintain:
- Current CVs for all team members involved in the study
- Formal qualification documentation relevant to their role
- Medical council registration numbers where applicable
- Evidence of protocol-specific training
- Confirmation that training was not required for lower-risk delegated tasks
Keep ethical documentation in order
The documents confirming ethical oversight are arguably the most important materials in the trial master file. Auditors will want to see that the study received appropriate review and that it has been maintained throughout.
Make sure you have current versions of:
- Investigator's Brochures (IB) where applicable
- Questionnaires and eDiaries
- Consent documents, including any updated versions
If any of these have been revised during the study, the version history and distribution records should be clear.
Document site visits and their outcomes
Every monitoring visit, outcome, and any issue identified should be recorded. Transparency here is important. Demonstrating that shortfalls were identified and addressed is far better than an audit trail that appears too clean to be real.
Keep a communications log
Correspondence covering significant study matters should be logged, including:
- Protocol deviation discussions and resolutions
- Monitoring visit outcomes
- Medical communications relating to adverse events or serious adverse events
This documentation demonstrates that important issues were escalated and managed appropriately, not left undocumented or resolved informally.
Where this maps onto the real inspection data
| This post's advice | The finding category it protects against |
|---|---|
| Delegation logs, training records | Adequacy of records |
| Protocol deviation logs, communications log | Adherence to trial protocol |
| Site visit documentation | Both categories, since it evidences ongoing oversight of each |
Two categories driving the majority of findings is, in one sense, good news: it means audit preparation doesn't need to be spread thin across dozens of equally weighted risks. Getting protocol adherence and records genuinely right addresses most of what an inspection is actually going to test.
That's not an argument for ignoring the smaller categories, safety reporting, monitoring oversight, drug accountability, informed consent, and IRB approval each still appear in the findings data, just less frequently. It's an argument for prioritisation when time before an inspection is limited. If a team only has a few weeks to prepare, protocol adherence documentation and record-keeping quality are where that time is best spent first.