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Regulatory authorities tend to abide by the maxim that 'If it isn't documented, it didn't happen'. Rigorous documentation of all aspects of a clinical trial is necessary to provide evidence of Good Clinical Practice (GCP) ...
Regulatory authorities tend to abide by the maxim that ‘If it isn’t documented, it didn’t happen’. Rigorous documentation of all aspects of a clinical trial is necessary to provide evidence of Good Clinical Practice (GCP) and compliance with regulatory requirements, as well as enabling effective management of the trial.
In this module we describe important examples of the documents designated by ICH GCP as essential to the conduct of a clinical trial.
| Credit Hours | NA |
|---|---|
| Method of Training | Online, asynchronous, self-paced eLearning |
| Average Learning Time | 30 minutes |
| Enrollment Period | 12 months |
| Accessibility | 24/7 access to all program materials |
| Demonstration | Four (4) free trial courses are available |
| Group/Employee Training | Request a quote |
| Final Assessment | Multiple choice; unlimited attempts |
| Digital Badge | Issued upon completion |
| Certificate | Encrypted PDF with validation QR barcode |
