2k Clinical Consulting, Inc.

Steps on Implementing a Clinical QMS

By Afifa F. – 2K Clinical Consulting, Inc. 

 There is a popular saying in quality management that if you do not have the process written down, then it probably didn’t happen. Just like any other business, Clinical trials must have a management system as well. This needs to be well-conceived  as well as systemized.  

 What is a QMS in Clinical Setup? 

QMS are standardized procedures with guidelines. These particular guidelines are the backbone for all procedures to be carried out. A clinical quality management system (CQMS) is meant to keep track of all the records, activities, tasks, processes, important events, interactions, inspections, and training that must be administered and controlled during the study’s lifespan.. 

 What are the Benefits of QMS in a Clinical Trial? 

The Clinical Quality Management System program provides improved patient safety by enhancing quality, ensuring data security, reducing clinical trial bottlenecks, and bringing products to the market faster. 

 QMS Implementation Steps 

The following steps must be covered to effectively implement Clinical QMS: 

  1.  Mapping and Defining Your Process  – The production of process maps will compel the associated clinical trial members to visualize and define its processes. They will determine the connection pattern of those operations to be carried out during the process. Process maps are essential for determining who is responsible. Lastly, they help to clarify the flow of the clinical trials execution. 
  2.  Defining the Clinical Trials Quality Policy – Objectives are required in all quality management systems. Each employee must recognize the impact they have on quality. Your quality policy influences your quality objectives. It’s quantifiable and implemented across all the project team members involved in the clinical trials process.    The goal could be in the form of key success criteria. This aids an organization in stressing the path to its mission’s fulfilment. These performance-based indicators provide a metric for determining whether or not the organization is meeting its goals. 
  3. Developing Scale to Track Critical Success Factor – Scales and measurements keep track of progress once important success criteria are defined. This can be accomplished using a data reporting technique that collects specified information. Leaders should be informed of the information that has been processed. The purpose of the method is to improve the customer satisfaction index score. There must be a goal and a metric for determining whether or not that objective has been met. 
  4. Defining Defects for Each ProcessNon-conformances occur as a result of a flaw in the product or a flaw in the process. It is necessary to measure and repair any problem that occurs. This can be done by determining what has to be done to fix the problem.
  5. Documenting and Keeping RecordsQMS includes keeping record of information in the form of documents. The golden tip is to start from a less hefty documentation and move onto the more important ones. 
  6. Defining the Process QualityInternal audits, management reviews, corrective and preventive action processes, and communication channels are all part of your quality assurance approach. 
  7. Understanding the Trainings to be IncludedEveryone must demonstrate competence in the job. Training is simply the beginning and can take place on the job, in a classroom, or virtually. Internal auditor competency and CAPA training are two significant training areas. 
  8. Using the QMSUsing the QMS ensures that the highest quality product is produced. The procedure entails gathering non-conformances and their records, auditing data in accordance with the corrective and prevention plan and reviewing data in accordance with the Failure Mode Effective Analysis (FMEA) to be prepared for any concerns.
  9. Measuring, Monitoring and Implementation of Plans to Improve Output – Using a quality management system entails gathering data and analyzing it to see if it is fit for purpose and can produce the desired results. You will have to keep track of objectives and define new metrics for performance. You must have a keen eye for details by recognizing trends, patterns, and correlation. After identifying trends, you and your team must prepare for arranging new objectives, plan prospects that will help you reach these new goals and must keep the mindset of “maintaining the quality”.  

 Key Takeaway 

In order to provide quality data and a clinical trial that is inspection-ready, a clinical QMS must be implemented. By doing so, you will be able to obtain and retain accreditation, which will be necessary both locally and internationally. 

Planning for TMF Success

Tackling the Trial Master File (TMF) can seem daunting at times. With so many moving parts and documents, it can get more difficult to manage as a clinical trial continually progresses. However, the TMF is essential as it tells inspectors the story of a study from beginning to end.  

Keeping the TMF up-to-date is crucial due to this very fact, but teams often struggle with getting it audit-ready due to disorganization and inconsistencies. Common challenges with TMFs (paper and electronic) are: 

  • Storing documents in several locations, making them difficult to access during an inspection.  
  • Limited collaboration between sponsors and CROs especially if there are different filing processes, systems, or incompatible software.  
  • Metrics can help provide key insight into organizational performance measures but  are also another source of frustration in TMF management because of the need to be updated regularly  

These challenges can be addressed with setting up a plan, specifically, a TMF plan which could help streamline processes.  

What is a TMF Plan? 

The TMF Plan details every aspect of TMF management. It sets boundaries and specifies who is responsible for specific TMF sections. It could contain a TMF Master List or TMF Table of Contents (TOC) that outlines procedures such as deadlines for each document, study reports, or specific milestones unique to each organization.  

The TMF Master List could also reference the Standard Operating Procedures, which describes each TMF document. Other types of information you might expect to see in this plan include TMF review frequency.  

What is the purpose of the TMF Plan? 

Transparency is key to building a high-quality TMF. The TMF Plan provides all information, data, and processes relevant to TMF management. This results in a complete TMF come inspection time and sets expectations for all parties involved. It is meant to keep sponsors, CROs, vendors, and other TMF stakeholders in the loop on everything from how documents are filed to the location of the TMF.  

What is the format of the TMF Plan? 

Having a TMF Plan is not required, but it helps keep everyone on the same page. It is especially important if the sponsor and CRO are both adding content and maintaining the TMF. Each organization will have its own approach as to how TMF management will work, and it generally helps to have TMF Plans that address the following TMF points:  

  • Official location 
  • Management procedure documents 
  • Breakdown of tasks & responsibilities 
  • Content filing processes 
  • Training and access management 
  • Structure  
  • How to add content  
  • TMF activity documents  
  • Formal archive plan 

The above will largely vary based on your organization’s needs, but it is a solid starting point in formulating your new TMF plan.  


Some of the biggest obstacles in a clinical trial are putting together an audit-ready TMF and having the metrics to back it up. You can avoid any of the unnecessary stress of inspections by having everything laid out from the start.  

Having a TMF Plan in place gives your team and other stakeholders a micro and macro view of the TMF management process, from content procedures to specific deadlines when TMF deliverables are due. As a result, the TMF plan keeps everyone on track throughout the clinical trial and sets everyone on the right path for future successful inspections.  

TMF Building Blocks to Inspection Readiness Success

An often-overlooked aspect of a clinical research study is the Trial Master File (TMF). As the backbone of every trial, the TMF houses all of the documentation describing all study activity in compliance with Good Clinical Practice (GCP) guidelines and approved protocols. With all of the moving parts involved in and outside of the TMF, it can be a constant challenge for all parties to keep up with. This is why it is so crucial to establish a foundation for success from the very beginning of a study.  

This article will discuss the building blocks of the Trial Master File in regards to how you and your team can set up, organize and manage an inspection-ready TMF.

How should you organize the Trial Master File?

Although there are TMF resources available such as the TMF Reference Model from Drug Information Association (DIA) and the general list of Essential Documents outlined in section 8 of the ICH E6 GCP guideline, it can be easy to lose track of documents without the proper TMF structures in place for your clinical trial. Overall, the TMF should be set up and divided into the following sections:  

  • Global/Core Files – This section contains documents used on a global scale. Trial-related, clinical or internal team reports, and clinical documents and templates are included here.
  • Country Files – This section contains country-specific documents. You can find documents from regulatory authorities and Ethics Committees, investigational product details, and country-specific documents and templates.
  • Local/Site Files – This section contains documents relevant to the sites participating in the study. There is usually documentation on Subject Information, site correspondence, monitoring, local laboratories, Institutional Review Boards/Ethics Committees, and site-specific investigational products or devices.

How do you manage the Trial Master File?

Management of the TMF can make or break a clinical trial. Without noting down study activity, we cannot prove that it even happened at all. While updating the TMF is not always the priority day-to-day, implementing measures and processes will help prevent any incomplete documentation or failed inspections in the future. Below are some strategies you can keep in mind for maintaining the TMF.

  • Training

First and foremost, everyone needs to be on the same page. From individual team members at a site to the CRO, each person and organization should understand the importance of maintaining the TMF and the procedures needed to do so. Make sure that the processes they are trained on follow the teams’ natural workflow if possible.

  • Clear Expectations

Even with the best training, sometimes we can go astray from protocol. The best way to keep everyone accountable is to have clearly defined roles, responsibilities, and expectations. Not only does everyone know what their part is in maintaining the TMF, but it also allows stakeholders to have an idea of how the study is progressing.

  • Self-Checks

Maintenance is not always enough when it comes to getting the TMF inspection ready. The team should also be conducting regular Quality Checks (QCs) of the TMF to ensure that it is up-to-date with all of the right documentation. Although time-consuming, it can make you more confident come inspection time.  

  • Bottom-line: Document Everything

At the end of the day, all of the effort put into managing trials will be in vain if it is not documented in the TMF. It’s not a matter of if you did the work, but rather, how you did it. Showing auditors a clear picture of the clinical trial with the documentation to back it up will make inspections easier for everyone.


By simplifying the organization and management of the TMF, you are also taking your team to the next level of enhancing your current TMF processes resulting in having a successful inspection from any regulatory authority.