Audit Time! What you Need to Cover

Being regulatory compliant is no easy feat. There are so many considerations to prove that you are conducting any research safely and ethically. While research teams and sites don't really want audits, they can be incredibly useful in keeping much needed gold standards and good practices (e.g. ICH GCP) at the forefront of your minds.

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When it's audit time, there are a few things you should consider ensuring that you're prepared:

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Carry out regular internal audits!

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Probably the most important thing you can consider before it's actual audit time. Have a few members of staff on rotation to audit various aspects of your conduct. You may even want to develop an SOP for this so items that need addressing aren't overlooked. Keep an objective mind and ask 'What would others look for?'. Ultimately your auditors (whoever they are) will want to know that:

• You know what you're doing
• People on-the-ground are trained and competent
• Any intervention you are providing has been signed-off accordingly and duly checked
• You are considering participant safety at every stage
• There is full transparency, and everyone is aware what is going on, and aware of what the risks are

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Make your sure delegation log up to date

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Anyone staff member taking part in your study/ies will be authorised to undertake specific actions throughout. This might be taking bloods, cross-referencing and signing consent documents, onboarding participants, carrying out interviews or administering interventions. Even management will have specific roles within the study. An up to date delegation log will outline who is (or has been doing) what. You don't want an auditor to identify someone who has been doing something they shouldn't have been.

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Training documentations: Keep them up to date

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On a similar thread to the previous point - you will want to prove that your training records are up to date. When you're undertaking higher risk studies, for example Phase I clinical trials, you will want to leave no room for errors that might put participants health, safety and wellbeing at risk. Don't forget that it's the principal Investigator's (PI) responsibility to ensure that all persons have been delegated effectively and responsibly.

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If appropriate, store a log of staff CV/resume's. It's also not uncommon for responsible persons to provide copies of any formal qualifications. For medical or pharmacology trained personnel, registration numbers by medical councils can also be logged.

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If training is not needed, even a log to confirm this can be useful. For example, a research nurse present at screening which doesn't themself conduct specific functions, might not need training for the research activity overall.

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If new protocols or procedures are in place, documents should be updated as-and-when members of staff have been trained in this new or amended area.

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REC/IRB approvals and updates

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Arguably the most important documents you need in a trial surround your ethical approval. Impartial and independent review boards (REC/IRB) will critique your study and ongoing communications around this should be documented. As well as providing evidence that your study was ethically approved, you'll want to provide assurances that this has been reviewed continually. Investigator's brochures (IB), any questionnaires, eDiaries and consent documents should be reviewed suitably to ensure they are still relevant throughout the trial.

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Site visit logs

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Have you had site visits? how many? what were the outcomes? were items raised and subsequently addressed? Be fully transparent here - where you have had shortfalls, it's ok, just be honest. Auditors will want to know that you are capable of rectifying issues that come to light.

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Communications logs

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If you've had any correspondances covering major aspects of the study, such protocol deviations, site monitoring visits and more. If there have been any medical communications regarding any specific matters, such as adverse or serious adverse events review, these should also all be documented.

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Have you been part of an audit, what do you look out for?