Configuration/Setup

[NOTE: Contacts are created in the database prior to using the Payments and Trial Master File modules.  To create a contact, go to: Create a Contact.]

Throughout the course of a clinical trial, numerous documents are created that are required to be on file with the Sponsor, contract research organizations helping to manage the trial, and/or at the sites participating in the trial.  Some of these documents may be regulatory in nature and are required to be on file to comply with federal, state or other guidelines.  Others may not be regulatory in nature but are tracked during the course of a clinical trial.  

An example of these documents is shown below in Table 1 below.  [NOTE: This list is provided as a sample of documents that may be used during a clinical trial.  Study Sponsors will choose which documents are to be tracked.]

Table 1: Sample “Trial Master File” Documents