I prepared document which may be helpful to applicants for clinical trials authorizations in the Czech Republic. The overview includes summaries of documentation required for CTAs, amendments, procedures description, information on Ethics submissions, references to applicable laws and guidelines and much more useful information. To view/download the document follow the link bellow.
Regulatory Requirements for Clinical Trials Conduct in the Czech Republic
2 comments:
This is very concise and detailed. Thank you! Will you generate this type of document for other countries?
Does this apply to studies involving medical devices also?
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