Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).
The TMF includes all of the documentation that a sponsor must record to demonstrate that they have met their obligations for the conduct of a clinical trial.
The Code of Federal Regulations states in 21 CFR 312.50:
`Sponsors are responsible for… ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND.`
The European Directive 2005/28/EC states:
`Trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.`
ICH GCP, Section 8.1 describes “essential documents” as those that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced.
Consolidated guidance for the industry on Good Clinical Practice (GCP) in 1996 was published by the International Conference on Harmonization (ICH). The objective was to provide a unified standard for the United States, European Union, and Japan to facilitate the mutual acceptance of clinical data by the regulatory authorities in these global jurisdictions.
The ICH document provided guidance for companies in all ICH regions to establish trial master files that contain key documents that enable the evaluation of the conduct of a trial and the quality of data produced uniformly by all jurisdictions involved. In the US, there is no specific requirement from FDA for companies to prepare a trial master file, but if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.
Documents contained in the TMF must be available for inspection by the appropriate regulatory authorities at any time during and after a clinical trial. They must be submitted to support the request for product approval. This is true for pharmaceuticals, biologics, and medical devices.
The TMF includes all of the documentation that a sponsor must record to demonstrate that they have met their obligations for the conduct of a clinical trial.
The Code of Federal Regulations states in 21 CFR 312.50:
`Sponsors are responsible for… ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND.`
The European Directive 2005/28/EC states:
`Trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.`
ICH GCP, Section 8.1 describes “essential documents” as those that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced.
Consolidated guidance for the industry on Good Clinical Practice (GCP) in 1996 was published by the International Conference on Harmonization (ICH). The objective was to provide a unified standard for the United States, European Union, and Japan to facilitate the mutual acceptance of clinical data by the regulatory authorities in these global jurisdictions.
The ICH document provided guidance for companies in all ICH regions to establish trial master files that contain key documents that enable the evaluation of the conduct of a trial and the quality of data produced uniformly by all jurisdictions involved. In the US, there is no specific requirement from FDA for companies to prepare a trial master file, but if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.
Documents contained in the TMF must be available for inspection by the appropriate regulatory authorities at any time during and after a clinical trial. They must be submitted to support the request for product approval. This is true for pharmaceuticals, biologics, and medical devices.
Why you should Attend:
You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file. This webinar will also benefit those involved in the conduct of clinical trials, audit and inspection of clinical trial study data and records, and submission of filings to regulatory agencies that involve clinical trial data.Areas Covered in the Session:
- Learn what content is required for a TMF for a clinical trial
- Understand how the essential documents demonstrate the conduct of the regulated activities of the investigator and sponsor
- Learn how to establish and maintain a well-organized TMF, and provide quality assurance for the data included
- Understand the importance of developing an effective Standard Operating Procedure (SOP) to support TMF activities
- Learn the importance of developing a consistent system for locating TMF documents, and preparing them for study team use or regulatory inspection
- Learn about best practices and industry standards
- Q & A
Speaker
Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.Who Should Attend
Personnel in the following roles will benefit:- Information Technology (IT) Analysts
- IT Developers
- IT Support Staff
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders using Computer Systems regulated by FDA
- Regulatory Affairs Personnel
- Consultants in the Life Sciences and Tobacco Industrie
- Interns working at the companies listed above
- College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA), or any other discipline that involves adherence to FDA regulatory requirements
