Clinical Study Report (CSR), Protocol (CSP), and Synopsis (CSPS) Templates – 10% off

Description

This is a complete package that includes the 3 essential document templates that are needed to design and report a clinical study:

• Clinical Study Report (CSR)
• Clinical Study Protocol (CSP)
• Clinical Study Protocol Synopsis (CSPS)

The Clinical Study Report (CSR) Template is specifically designed to be used in conjunction with the Clinical Study Protocol (CSP) Template.

The structure and sections as well as their order and content follow the International Council for Harmonisation (ICH) E3 guidelines for CSRs, as recommended by the Food and Drug Administration (FDA). As such, this CSR Template is the foundation for an “integrated” full report of any study with a therapeutic, prophylactic, or diagnostic agent (i.e., drug or treatment) conducted in patients or healthy volunteers.

The Clinical Study Protocol (CSP) Template is specifically designed to be used in conjunction with the Clinical Study Protocol Synopsis (CSPS) Template, and intended for straightforward transfer of information to the associated Clinical Study Report (CSR) Template.

Although each clinical study is unique in its design, the sections of this CSP Template include all the fundamental components of a study design, per the International Council for Harmonisation (ICH) guidelines. Moreover, the structure and sections as well as their order and content follow the ICH E3 guidelines for CSRs, conforming to the and Food and Drug Administration (FDA) requirements for proper study conduct. This enables content of the finalized CSP to be directly copied into the equivalent sections of the associated CSR Template, with only minor modifications to the tense as instructed throughout.

The Clinical Study Protocol Synopsis (CSPS) Template is specifically designed for straightforward copy-and-paste transfer into the associated Clinical Study Protocol (CSP) Template.