Contacting subjects after they have completed a study
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A CRO is instructing their CRA to ask site staff to contact patients after they have completed a study to clarify unclear diary card data. The patients have not consented to being contacted after the end of the study but the CRO is insisting. What guideline/regulation can be shown to the CRO to convince them that this is not acceptable. Thanks for any advice.
I don't know of anything which stops clinical investigator sites from contacting subjects about visits they have already made unless the consent form is incredibly restrictive and says they can't. Contact about visits and tests tgey have already done is part of the study they consented to, it is different if they were asked for more visits or tests which they had not consented to. ... How restrictive is your consent!!! Your ethics committee might also be able le to help
Thanks Colin. I took your advice and contacted the REC who then referred it to the HRA queries line. Their response was "Whether it was acceptable to re-contact patients would depend on whether consent was provided for further follow up contact within the study, this would need to be assessed by the study sponsor as to what was detailed in the original PIS and Protocol."