Medical Images Requirements

[superpiran]

Hi did you ever get a satisfactory answer for this query?
Thanks

[MHRA Moderator]

If you wish to receive an MHRA response to this query then the expected way to achieve this is to email the MHRA Clinical Trial Helpline. In this case, without full knowledge of the trial, it would appear that the data the service provider holds is likely to be source data, i.e. if it is not certified copies of images that are at the investigator sites and there may be data/meta data/information as a result of any analysis performed by the vendor which would also be source data. This data should not be provided to the sponsor. Further information see the EMA reflection paper.

http://www.ema.europa.eu/docs/en_GB/...C500095754.pdf

[lehoangrose]

I will download this WC500095754.pdf

Wow It has 13 Page

Thank you