22nd Dec 2014, 08:17 PM
Medical Images Requirements
As the Sponsor, we have received notification from the Medical Imaging Service Provider that they have completed the final data transfer for our study. The Medical Imaging Service Provider has contacted us (Sponsor) regarding our needs for data archival. The Medical Imaging Service Provider can either archive the study images, data and materials, or they can send it all to us (Sponsor) for archiving. Is this data considered "source documents" and as the Sponsor can we accept it? Where could I find some guidelines/guidance documents on the subject?
1st Nov 2016, 04:33 PM
Hi did you ever get a satisfactory answer for this query?
2nd Nov 2016, 09:44 AM
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.
11th Jan 2017, 03:46 AM
I will download this WC500095754.pdf
Wow It has 13 Page