Colleagues
I would be grateful for feedback on your experience in conducting clinical audit post introduction of General Data Protection Regulations. Has ethical approval become more complex? Are junior colleagues/trainees dissuaded due to the extra regulations and paperwork? How has this applied to studies involving retrospective chart review with collection of anonymized data?
Are there any useful published guidance on this matter?
many thanks for your feedback.
I suggested and updated our organisations QMS after the introduction of GDPR and this worked. I gave training on implementing the changes which we made and this made it very clear and easy for junior colleagues and trainees to apply.
Since this we were only audited by one of our big Pharma clients. We also updated our study specific SOPs for ongoing projects.
I don't think that there is much you can do retrospectively, unless you are looking to use that data again for new studies you willed to gain 'reconsent' or contact HRA concerning this.
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