Giuseppe Carissimo, Data Manager
What are the specificities of setting up image collection during clinical trials from a technological perspective?
The most important thing is to know in advance what type of files the operating sites will provide, as well as a rough estimate of how many files per patient they will upload. We use this information to set up sufficient storage on our EDC, EdClin, and provide a precise budget estimate to the client. We also need to know in advance if the files will be used as they are, or they will need to undergo any type of treatment (pseudonymization, anonymization, editing, conversion, compression, etc.), again for reasons of resource allocation and budgeting.
What type of images can be uploaded? In what format are they processed?
Our platform currently allows the upload of .DICOM, .PDF, .PNG, .JPEG, and .DOCX files, with the possibility to ultimately convert them all into .PDF format. Working with EdClin, there is no limitation in terms of file size: we tend to allocate a limited space on a server for the upload but have the possibility to upgrade the storage size at any moment. In fact, the main limiting factor during upload is usually the internet speed on the side of the operator uploading the file(s).
Is video upload possible?
Although the function has never been fully exploited, it is technically possible to upload video files, provided that no image treatment is required after the upload, since pseudonymization, anonymization, etc. for video are much more complex for evident technical reasons.
What differentiates the technological environment at ClinSearch in relation to Core Lab management?
The upload is performed directly on the EDC, which provides two main advantages. First, the whole process of upload, pseudonymization, and storage is fully centralized and makes the images virtually accessible from any computer connected to the Internet. Second, it is possible—if required, to link all the uploads to a variable/item/field/event of the CRF (for example, the final user will always know which of two scans was provided from baseline and which from a follow-up evaluation, thanks to the referencing of the images operated via the database). Lastly, it is crucial to point out that the technology we use depends on the outcomes of the risk analysis made by the ClinSearch DPO with the assistance of the operational and IS teams. I believe that makes the difference. It often happens that, after launching their studies, Clients ask us to amend the remote data system of their Core Lab to comply with data privacy regulations.
Petra Ulm, Global Regulatory Affairs Director & DPO
What are the specificities of setting up image collection during clinical trials from a regulatory perspective? Do you mean regarding clinical trial application to Authorities or in general?
There are no specific requirements pertaining to images in the GDPR. In other words, they are treated as any other personal data. Therefore, the highest security measures have to be applied and, as other patient data, images have to be pseudonymized by the hospitals before their upload to the eCRF. Our eCRF has the function to do the pseudonymization, which is a major advantage because not all EDCs do. We can also allocate resources to perform anonymization on site if required, which is an increasingly requested service by our clients.
What are the current regulations about DSMB/Core Lab member selection?
As a minimal requirement, the Member has to be an expert in the field and independent of the study team. That is to say, the Member cannot be an investigator or a co- investigator, to ensure no conflict of interest can arise. Aside from that, the Members’ number and required specialization is defined according to the complexity of the study design and analysis and the level of risk to human health posed by the product being studied.
Cecile Train, Sr Director Pharmaceutical & Medical Device Development
What is a common scenario of DSMB/Core Lab use by ClinSearch clients?
So far, our team has supported use of Core Lab primarily in neurovascular trials. Specifically, we have done a lot of work with ECG imaging with Zoll, one of our long-term clients. The total number of studies we have supported is around a dozen, with a similar number of ongoing requests from clients. Over the years, we have definitely observed an increase in DSMB/Core Lab use in both pharmaceutical and medical device trials.
What experience does the ClinSearch team have in DSMB/Core Lab set up and management? What dedicated processes & resources?
We have been involved in the initial stages of studies: in preparing recommendations for DSMB/Core Lab use and supporting sponsors in choosing committee members. In addition, our CRAs and Deputy Project Leaders have worked on anonymizing all patient materials, translating and proofreading source documents, and preparing the narrative of patients’ history of participating in the study, their images and SAEs. We have integrated SOPs governing the processes internally, continuously updated according to changing standards & practices.