The Clinical Study Report (CSR) Flashcards
(12 cards)
In which Module of the eCTD can you find CSR’s?
CSR’s are placed in Module 5 of the dossier.
Why are pivotal CSR’s important?
Pivotal CSR’s are so important provide the foundation of the dossier on which the clinical summaries, Clinical Overview and ultimately the label are built.
What is the minimum number of CSR’s contained in a clinical study?
Every clinical study has at least one CSR to present the results. During clinical development of the molecule, many CSR’s will be written.
Who is responsible for authoring, compiling and managing the process of creating a CSR?
The Medical Writer
What other functions that are involved in the process of creating the CSR?
- Biometrics Clinical Science Safety Science Clinical Operations Project Management Clinical Pharmacology Cluster Head of Biostatistics
What are two key components of the structure of a CSR?
Every CSR contains a title page and a synopsis.
How long can a CSR be?
It varies depending on the appendices included. It could be 10,000 pages.
What is the length of the typical Synopsis of a CSR?
Typically, the Synopsis part of a CSR should be limited to 2-3 pages but in reality it can often be 7-8 pages.
In which part of the CSR would we include patient narratives?
In the appendices of the CSR.
Who is involved in the process of building a content map?
The PDRD Author collaborates with the Biostatistician, Clinical Science and Clinical Safety.
Can literature references be included in a CSR?
Yes they can, but they should be kept to a minimum and do not include them in the submission.
Once the first draft of the CSR is available, how many review rounds does it have to go through?
Three review rounds.
Author team review
Cross-functional review
Final functional review
