What goes in a trial master file?

A trial master file contains essential documents for a clinical trial that may be subject to regulatory agency oversight. Those documents shall show whether the investigator and the sponsor have complied with the principles and guidelines of good clinical practice and with the applicable requirements.

What is a trial master file plan?

The Trial Master File refers to a repository of documents that collectively can be used by monitors, auditors, assessors and sponsors to demonstrate that a clinical trial has been conducted in compliance with Good Clinical Practice (GCP) and the approved protocol.

Where are trial master files kept?

The TMF should be held at the coordinating site (usually the Chief Investigator’s office or Coordinating Centre) and for multi-site trials, copies of relevant documents should be kept at each participating site in an Investigator Site File (ISF).

What does eTMF stand for?

An electronic master file or eTMF is a Trial Master File in electronic or digital format. It is a way of digitally capturing, managing, sharing and storing those essential documents and content from a clinical trial. To understand further, let’s first describe what a Trial Master File or TMF is.

What is a trial master file specialist?

Liaise with Regulatory, Quality, and other task area leads to reconcile TMF documents which have been received from various functional areas to ensure completeness and quality of files. Ensure compliance with ICH, U.S. federal regulations, and NIH policies and procedures.

What is the purpose of trial master file?

The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed.

What is the difference between TMF and ISF?

PAID MESSAGE – The Trial Master File (TMF) is held by the sponsor and represents the story of the study of the study. The Investigator Site File (ISF) is held by the site and represents the story of the study at the site.

How long must clinical trial records be kept?

2 years
An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication …

Who CRO file master?

A contract research organization master file (CROMF) is a document prepared by the contract research organization (CRO) containing specific and factual information about the CRO and the conduct of clinical studies as well as the analyses of samples and related operations (including clinical trials, clinical data …

Who is often delegated by the sponsor to maintain the TMF?

The TMF forms the basis for an inspection to confirm compliance with regulatory requirements (Directive 2005/28/EC Chapter 4, Article 16). The TMF is normally composed of a sponsor TMF, held by the sponsor organisation (or to whom this function is delegated), and an investigator site TMF, held by the investigator.

Why is eTMF important?

An eTMF gives you the ability to create or upload documents directly into the system. Once these documents are uploaded and stored, it’s important that users have the ability to search for them based on document metadata and content. This makes it easy to locate, retrieve and view specific documents.

What is the definition of a trial master file?

TMF definition. A trial master file contains essential documents for a clinical trial that may be subject to regulatory agency oversight. In the European Union (EU), TMFs have a different definition and set of requirements than in the US. The EU Commission’s Directive 2005/28/EC 63 Chapter 4 states ‘the trial master file shall consist …

When does a clinical trial master file need to be archived?

Article 58 requires that “the sponsor and investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial.”

When is a clinical trial not an applicable clinical trial?

If a clinical trial is not an applicable clinical trial (ACT) at study initiation because it is conducted entirely outside the United States, but the trial subsequently opens a U.S. site, am I required to register the trial?

What are the SOPs of a clinical trial?

Standard Operating Procedures for Clinical Trials (SOPs) 1 Clinic Flow policies & procedures. 2 Clinical research management plan. 3 Consent. 4 Protocol implementation. 5 Source documentation. 6 (more items)

Is the trial master file the Golden Rule?

The Trial Master File (TMF) is the foundation of every clini- cal trial, and a strong foundation is essential to the overall health and stability of any clinical trial. The Golden Rule in clinical research (which also applies to the TMF) is,

What does it mean when a jury trial get put on a Master?

When a jury trial is put on the Master Calendar, that court will assign it to a trial division for the trial to take place. A plea can be reached before the trial occurs. A plea can, technically, even occur during trial and upon its conclusion prior to a verdict.

What does master protocol mean in clinical trials?

The FDA guidance document describes such considerations in Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics. Master protocol is the general term that describes a trial design with multiple sub-studies which may have different objectives and evaluates one or more drugs or one or more diseases.

Why is the trial master file so important?

The Trial Master File (TMF) is one of the most important deliverables of a clinical trial because it is the basis for inspection. ICH GCP Release 2 states that Essential Documents are those documents that individually and collectively permit the evaluation and the conduct of a trial and the