Q&A with Timea Peter, Clinical Project Manager, genae Germany
Q: Are sites involved in the submission process?
A: We have routinely incorporated the involvement of investigators into the review of Informed Consent Forms into our workflow. Typically, they are provided prior to submission and they are actively encouraged to comment on the content.
The early involvement into the review process ensures that the investigators feel comfortable with the content and feel comfortable to discuss the content of the Informed Consent Forms later on with their patients. This way, changes later after the SIV can be avoided.
Discover our other Q&A videos:
• Which medical devices fall under the new EU MDR scope?
• Which country should I go to for my clinical trial?
• By when do I need to update the Clinical Evaluation Report (CER)?
• Are there any aspects that should be considered during the site selection process which affect the submission?
• How will the new EU General Data Protection Regulation (GDPR) affect my clinical trial?
• Why is it important for manufacturers to focus on the health economics of their device?
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