Clinical trials can be audited for GCP compliance, and GCP audits serve various purposes relative to the Clinical trial process. It is not always a site(s) and monitoring Audit — a GCP audit can be a full clinical trial audit of systems and operations conducted.

In-process audit assesses whether the principal investigator and site support personnel adhere to regulatory requirements outlined in the clinical trial protocol and the clinical quality management, and it is a critical interface to ensure compliance. Audits of a clinical trial will focus on the integrity of this process and the compliance of the site with all aspects of the protocol and the actions of each person who handles some aspect of the clinical trial.

Auditing aims to prevent problems by fostering the development of a responsible research team. Investigators who understand the importance of faithful adherence to the clinical trial protocol will likely recruit and train support staff who are careful and honest in data collection and reporting.

The History of the Clinical Audit

One of the first clinical audits was undertaken by Florence Nightingale during the Crimean War of 1853–55. On arrival at the medical barracks hospital in Scutari in 1854, Nightingale was appalled by the unsanitary conditions and high mortality rates among injured or ill soldiers. Another notable figure who advocated clinical audit was Ernest Codman (1869–1940). Codman became known as the first true medical auditor following his work in 1912 on monitoring surgical outcomes. 

Codman’s “end result idea” was to follow every patient’s case history after surgery to identify errors made by individual surgeons on specific patients. Although his work is often neglected in the history of health care assessment, Codman’s work anticipated contemporary approaches to quality monitoring and assurance, establishing accountability, and allocating and managing resources efficiently.

Clinical audit is a quality improvement process that was introduced to the NHS by the 1989 White Paper Working for Patients. Previously known as medical audit until a name change in the early 1990s, clinical audit involves reviewing the delivery of healthcare to ensure that best practice is being carried out.

Since in-process audit was introduced in the late 1980s, there have been many different definitions. The current accepted definition first appeared in Principles for Best Practice in Clinical Audit (2002) and was retained in New Principles for Best Practice in Clinical Audit (2011):

“Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, process and outcome of care are selected and systematically evaluated against explicit criteria. Where indicated changes are implemented at an individual, team, or service level and further monitoring is used to confirm improvement in healthcare delivery”.

In 2016 NHS England published a new definition for clinical in-process audit that reads as follows:

“Clinical audit is a way to find out if healthcare is being provided in line with standards and let’s care providers and patients know where their service is doing well and where there could be improvements. The aim is to allow quality improvement to take place where it is most helpful and will improve outcomes for patients. Clinical audits can look at care nationwide (national clinical audits) and local clinical audits can also be performed locally in trusts, hospitals or GP practices anywhere healthcare is provided”.

Who conducts the In-Process Audit?

Clinical Quality Assurance (QA) Auditors analyze elements of clinical research and development (CR&D) trial activities, all the planned and systematic actions are established to ensure that the clinical trials are performed, and the data is generated, documented, and reported in compliance with GCP and applicable regulations. Non-compliance can lead to failures, delays, unrecognized adverse events, and most importantly, compromise the integrity of the trial data and protocol. This could lead to a challenge of the clinical trial results by regulatory authorities.

The site QA is responsible for ensuring all study staff has completed all required BioPharma Services specific and protocol-specific training and that these trainings are documented appropriately in the training log. The QA will verify a delegation of responsibilities to ensure the study staff is delegated appropriately and documented in the log.

The QA In- process Audit report will include assurance of:

• • Staff updated training records
  • Appropriate protection of subject information
  • Consent process completion
  • Source document completion and review
  • CRF review to minimize correction of induced data entry errors
  • Assurance of ongoing equipment calibration and maintenance
  • Proper handling of investigative products, Documentation addressing accountability, Dispensing,
  • Awareness of any protocol or study changes based on shared data with investigators
  • Facilities and Equipment,
  • Documentation of laboratory inspections
  • Records of temperature logs and temperature excursions

4 steps for conducting internal audits

The key to an effective audit, whether internal or external, is good planning. The essential steps involved are: planning, executing, reporting and follow-up/closure. When you’re conducting an internal audit, your company has complete control over the process. Use this to your advantage by creating a roadmap that will help you meet your objectives and follow your procedures. In smaller companies where employees wear many hats, ensure there are no conflicts of interest and that sufficient time is allocated to complete the audits and reports.

Audit Planning 

The initial stage of getting ready for an audit involves identifying the general extent and goal of the audit. After this is established, the designated representative from management or the quality manager will strategize the complete in-process audit cycle by utilizing the internal protocols, documents (audit checklists and reports), and methods. They will appoint different employees as auditors and allocate which areas will be audited to guarantee that the overall objectives of the company are achieved throughout the audit procedure. In-process Audit execution  

This phase should allow the auditor to become familiar with the area being audited. At this step, processes may be pulled ahead of time (data gathering), previous corrective actions, previous audits, meeting with key team members, and tours of areas are usually the first steps for successful audit execution.

Remember to put auditees at ease during your audit by communicating what is being audited and the format being used (e.g. direct interviews, reviews of process related documentation, demonstration of the workflow, etc.). During the in-process audit, you’re looking for compliance, but you should also be looking for opportunities for improvement and possible inconsistencies in the system. 

For example, you may notice one area has a streamlined way of meeting its objectives that could be shared with other areas. Someone with an auditor’s perspective might be the only one to observe these types of opportunities for improvement. 

In-process Audit reporting 

The output of the audit investigation is the audit report, where you will compile all your audit findings. An audit report is used to communicate to respective area management and top management the results of the internal audit. The report should be done as soon as possible and be clear and concise, so management can address potential organizational issues. The key members of the areas being audited should be involved in any follow-up corrective actions required for compliance.

Successes should also be reported, so the entire picture of quality performance improvements is tracked over time.  Successes should also be reported and communicated for the entire picture to be tracked for quality performance over time. If no corrective actions or opportunities for improvement are necessary, the in-process audit can be concluded for that area.

Audit follow up/corrective action/closure

After completing the necessary audits in all designated regions, the lead auditor or representative from management will ultimately decide which areas require corrective measures and further assessments. While it is obligatory to inform top-level management of the audit findings, it is the key members who possess the greatest understanding and personal investment to ensure that the necessary actions are taken, and the situation is fully resolved. 

The specific manager in charge of each area should take responsibility for overseeing the follow-up tasks and keeping detailed records of their completion. These tasks may involve updating procedures to incorporate the necessary changes, followed by providing additional training for compliance, if needed.

Final in-process audit sign-off can be completed by the lead auditor once they have evidence that all the corrective actions or opportunities have been implemented/satisfied. This may require a full re-audit of the area, but that’s not always necessary. Once the audit objectives are complete, the entire audit can be closed, and the results should be communicated to upper management for tracking at regular intervals during management reviews. 

In-Process Audit Goals

The objective of an in- process audit is to assess the adherence of processes to established standards and procedures, as well as identify any inefficiencies within the system. Quality assurance (QA) is responsible for evaluating compliance with proper documentation and provision, and may uncover instances of non-compliance, whether major or minor, which can reveal undisclosed processes or disarray in the management system. 

QA often employs an audit checklist, a tool or document that facilitates the audit process by containing pertinent information such as the audit’s scope and evidence collection methods. By using a checklist, businesses can achieve consistency and organization in their in-process audit procedures, enabling them to identify areas for process improvement

Is an Audit Checklist required?

Yes.

An audit checklist although not mandatory is usually required, and it is highly recommended that your organization has an internal audit checklist as it serves as an avenue for the collection of evidence to identify non-compliance, findings, and improvements within the procedures and processes that have been implemented.

How to Create an In-process Audit checklist

To start preparing an audit checklist, it is important for your organization to understand what needs to be audited. This leads to the identification of the audit scope, objectives, and criteria.

Consider the following steps to create a checklist for your process audit:

1. Understand the purpose of the audit

Using this information, you can create an audit checklist that helps answer questions that may have about the efficiency of their processes.

2. Create the main heading of the checklist

Next, you can create the main headings of the auditing checklist. For example, you may include a subject safety section, an equipment section, a support processes section, and a section to evaluate key performance. The main headings of your checklist may depend on the goals for conducting an audit.

3. Create subheadings

Once you have your main headings, you can create your subheadings. Examples of subheadings include record keeping and procedures for reviewing specifications, You may also decide to format your checklist without subheadings and instead include your questions under the main headings.

4. Create columns for evaluating compliance

Besides your subheadings, you can create columns for each audit question where you can provide evidence and suggestions for improvement. The evidence section of your checklist is an opportunity to discuss your sources for documentation so you can show how you verify how the processes comply with guidelines. You can format your checklist using a scale of compliance that includes complete compliance, a need for improvement, some compliance, and complete non-compliance.

4. Create a section for adding suggestions

The suggestions’ column allows you to discuss how a business might improve its processes. After you gather the important documents and information necessary to conduct a full audit, you can leave any comments or suggestions regarding the analysis for clarity. For example, you may suggest more supervision for allocating resources to improve employee satisfaction and productivity.

Benefits of Internal Audits

An internal audit is a starting point for determining gaps and opportunities for improvements. They should be welcomed, not avoided. Audits are frequently feared and seen as a disturbance to regular workdays, but an internal audit is quite the opposite. 

Internal audits are a beneficial management tool that should be seen as a learning opportunity, especially for any company that wants to improve quality management systems. The immediate internal benefit is a streamlined process, but the overall objective might be to determine if the company is ready for an external audit to garner or maintain an industry GCP standard.

To implement GCP Audit readiness, ensure personnel understands the protocol and the scientific details of the trial. Successful internal audits are the first step in maintaining a strong quality management system. There are many benefits to internal audits that help in the short term, while also being beneficial for long term goals of continued regulatory compliance, external certifications, and customer-required objectives. Prioritizing internal audits on a regular basis will show employees, clients, and other interested parties that your organization is committed to quality. Successfully conducting internal audits will lead to a more efficient and effective organization that is better prepared to meet the demands of future audits and regulatory standards.