Trial Master File
Pharmaceuticals are currently considered the most highly regulated industry worldwide. The pharmaceutical regulatory bodies ensure compliance in various legal and regulatory aspects of a drug. Every country has its own regulatory authority which is responsible for enforcing the rules and regulations and for issuing the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing and labeling of pharmaceutical products. There are some documents that are common to every aspect of the trial in every country. The TMF structure takes this into account and categorizes the documents accordingly.
For each new clinical trial workspace, the system automatically creates a Quick Launch Bar section titled “Trial Master File”. The Trial Master File (TMF) contains the following libraries where the related documents will be stored after they are added to the trial:
Trial File
The Trial File contains the trial or study-level documents, major and minor versions, related to the clinical trial associated with the workspace. These documents are standard and required for every country and site.
Country File
Since every country has its own agency to control health care products, it follows that each country would have very unique guidelines for the pharmaceutical field, therefore, the documentation requirements vary from country to country.
The Country File contains a folder for each planned country. The country folders are added when the workspace is created and are based upon the countries selected when the new clinical trial is added to the hub. Each folder contains the country-level documents for that country that are related to the clinical trial associated with the workspace. The documents are major and minor versions.
Site File
An Investigational Site, or a site, is one location that is participating in the trial. The sites may contain common documents that must be completed for each site. For example, a curriculum vitae (CV) for the study coordinator would be personal to the study coordinator in each site and a requirement for that document would be added to each site.
The Site File contains a folder for each trial site included in the study. Each folder contains the site-level documents related to the clinical trial associated with the workspace. It contains major and minor version documents.