This course is suitable for those working with clinical trial documentation, whether in generating the documents, filing and document management or archiving.
Document management is critical to success of clinical trials and also key for transparency. This can be a complex process with documents created in a combination of paper and electronic formats. This course will provide delegates with the following:
Outline of the key documents required
Overview of Document management techniques
Practical advice for both electronic and paper archiving
Delivery of the course will consist of a combination of presentations by the trainer, group discussion and case studies. This course will also be supported by additional resources available through the PharmaSchool Learning Management Centre.
Why Do We Have To Have Essential Documents?
Where Do I Start?
Before The Trial
During the Trial
After the Trial
Filing: TMF and ISF
Version control – paper, electronic and scanned documents
Rationalisation of multiple copies
Dealing with the gaps
Finalising the documentation