In this interview, we speak with Retha Britz, a clinical research professional with 27 years of experience and 17 years as an independent GCP/GCLP auditor, working largely across African countries and globally.
She shares how her career shifted from industry roles to independent consulting, how this shaped her audit style, and what really happens “on the ground” at investigator sites and laboratories.
Retha talks about the most common findings she sees worldwide - especially poor documentation and weak informed consent practices - and explains which failures truly threaten patient safety and data integrity.
She also compares onsite and remote audits, highlights typical gaps in laboratories, and discusses how teams should act when compliance and real‑world patient realities collide.
Throughout the conversation, she returns to one core theme: excellent auditors do far more than follow checklists.
They use logic, understand processes deeply, and build a holistic “big picture” from many small pieces of information.
Whether you are a CRA, QA professional, trial manager, or an aspiring auditor, this interview will help you understand what it really takes to audit with insight, protect participants, and ensure reliable data.
Retha, could you briefly introduce yourself and your current role in Quality Assurance and auditing?
What motivated you to focus your career on GCP/GCLP/GLP audits and compliance?
How has your experience in both pharma/industry roles and independent consulting shaped the way you audit today?
You have audited investigator sites and laboratories across different countries and regions. What are the most common compliance challenges you see globally?
From your experience, what are the biggest differences between onsite audits and remote audits - and what should auditors be mindful of in each format?
For both types of audits, time is always an important aspect, because you must work fast and efficiently to review as much data and as many aspects as possible, while still leaving enough time to investigate any issues that you come across.
Which types of findings tend to have the highest impact on patient safety or data integrity?
- Informed consent failures have a high impact, as participants may not have legally or ethically agreed to participate.
- Protocol deviations that affect eligibility or endpoints of the study may invalidate trial results and/or expose participants to risk.
- Safety reporting failures may prevent the detection of risks to participants.
- Investigational product control failures may expose participants to risk.
What are the most frequent root causes behind recurring audit findings at clinical trial sites?
Retraining is, in most cases, not the solution on its own. Do not forget about effectiveness checks, which must be performed to ensure that the change in process is effective.
What are the key elements you always evaluate during a GCP investigator site audit?
- Availability and completion of executed informed consent forms.
- Completeness of the Investigator Site File (availability of essential records).
- Investigational product inventory, storage conditions, and dispensing/accountability.
- Source data review against entries in the data acquisition tools.
When auditing laboratories (GLP/GCLP), what are typical gaps that teams often underestimate?
In your view, what makes informed consent truly compliant - and ethically strong - in real practice?
- Properly completed informed consent forms without errors.
- The quality of information that the documented informed consent process contains in the source records.
What mistakes related to ethics and patient rights do you most often see during audits?
- Mistakes in informed consent practices, including lack of a comprehension assessment after the informed consent discussion.
- Confidentiality breaches of participant personal information, for example messages regarding the study left for the participant with someone other than the person to whom the participant consented to receive information, or participant identifying information submitted to third parties as part of supporting documentation for SAE reporting.
How should clinical teams handle situations where compliance and real-world patient realities seem to conflict?
What distinguishes an excellent auditor from someone who only follows a checklist?
- Insight into how clinical trials work:
- Insight into GCP and other applicable industry standards, legislation; and regulations of the specific country;
- Insight into the options available for every aspect reviewed;
- and insight into the study protocol and its requirements.
What core skills do you believe every future auditor must develop to be successful in today’s clinical research environment?
- A very fine eye for detail.
- Strong time management.
- Deep knowledge of industry standards.
- The ability to use logic.
What is one skill that junior auditors often overlook, but which becomes critical as they grow professionally?
Auditing is a skill, like building a puzzle. Only at the end of the audit do you have all the pieces and can holistically see the bigger picture of what is truly missing from the “picture”. Every piece of information obtained during the audit is like one puzzle piece that helps you get to that bigger picture.
You are an experienced trainer and lecturer. What is your approach to teaching professionals effectively?
- Use real-life examples to demonstrate the theory.
- Make training interactive, as this is the best way to teach and to learn.
There is a need for excellent auditors in the clinical trial industry. I believe in interactive training and felt that I could contribute positively to the education of future excellent auditors. I am very excited to be a trainer for this world‑class opportunity that is so needed in our industry.
What practical outcomes do you want participants to achieve by the end of your training sessions?
- To feel comfortable using and applying the new skills, knowledge, and techniques that they have learned during the training sessions.
- To feel confident in the way they conduct an audit, knowing that they are checking the correct aspects so that the evaluation and assessment truly reflect whether participant rights, safety, and wellbeing have been protected and whether the trial data are reliable.
What typical mistakes do you want to help students avoid early in their auditing careers?
- Feeling overwhelmed by all the information to be reviewed during an audit.
- Inefficient time management during an audit.
If you could give one key message to future Auditor School participants, what would it be?
If this interview resonated with you and you want to build the same level of confidence and structure in your audit work, you can learn directly with Retha in the GCP Auditor School by The QARP Academy.
This fully remote, practice-oriented program provides a complete 10‑week pathway to the Certified GCP Auditor qualification, with real audit simulations, case-based learning, and weekly live expert sessions.
You can join the full certification track or select individual modules that match your current role and goals, from foundations of auditing and QMS to audit execution, interviewing techniques, CAPA, and soft skills for auditors.
If you are ready to move towards a dedicated quality and auditing career in clinical research, visit the GCP Auditor School page and reserve your spot in the upcoming cohort.