|
Protocol Writing, CRF, reports,
publications, submissions |
|
Selection of Investigators, Set-up
of Study Sites |
|
Regulatory and Ethics Committee
Application |
|
Project Management |
|
Monitoring |
|
Continuous Status Updates: Patients,
Adverse Events |
|
Source Data Verification independent
of Local Language |
|
Quality Assurance |
|
Statistical Planning, Evaluation and
Medical Report |
|
Post Marketing Surveillance/Post
Authorization Safety Studies |
|
Countries in which ECRON is
operating |
|
What's new? |
|
ICH-GCP (step 5), Chapter 5.18.4.
ff: monitoring |
|
list of external links |