Majority of the clinical trials require images to be performed and often sent to external vendor. These imaging requirements vary between different clinical trials and information about specifications should be available before the start of the study. It is important imaging requirements to be communicated with radiology team as early as possible to assure that they can commit to the study and perform all images as per protocol. Once radiology team has confirmed they can do the images the set up can commence.
Some hospitals are lucky to have radiology coordinator who is looking after clinical trials and is a main point of contact. Usually the radiology coordinators are familiar with set up requirements for clinical trials and they can support smooth study start. However, not all hospitals have radiology coordinators and often radiology set up is done by clinical trial coordinator who is not necessary familiar with all specifications (especially if the person is not experienced).
What is required for radiology set up?
- Radiology team has to be provided with detailed information about imaging and confirm that they will be able to perform the assessments.
- You need to identify (from the protocol or imaging manual) if the clinical trial will use external vendor to archive and analyze imaging data.
- If external vendor is involved you will need to discuss acceptable options for data transfer with Sponsor and your radiology team. Some hospitals prefer electronic data transfer, while others – sending images on CDs or DVDs.
- In case of external vendor, you will probably need to submit so called “site qualification image”. This image should be blinded and should not be performed on a patient. The idea of qualification images is external vendor to assure that the hospital equipment meets the required standards to participate in the study. For some clinical trials each radiologist involved in the study has to submit qualification image, while others require only 1 image. External vendors normally provide all required information and supplies to perform qualification image. Once the site has qualified the radiology team can start performing radiology assessments.
Sending images electronically or hard copies could have its advantages and disadvantages.
Electronic data transfer: Almost all hospitals use PACS (Picture Archival Communication System), which allow storage and transfer of digital radiology images. The very same method is used to transfer data electronically to external vendor although you may need some extra software provided by the external vendor. The biggest advantages of electronic data transfer is that it is quicker to obtain the images and send them to the vendor. Also electronic images are available to be re-sent if required. Some of the disadvantages are: poor Internet connection in the hospital could make image transfer very slow or almost impossible. Another issue is that often electronic data transfer is not an option if the study require live images or videos, which could be very big size and extremely hard to upload.
Hard copies data transfer: This is another method when radiology team provides images on CDs or DVDs. Then the study coordinator has to arrange these images to be couriered to the external vendor. One of the advantages of this method is that you can send big files, which will be difficult to transfer electronically. However, there are some disadvantages too: often it takes longer to obtain the images from radiology team because they have to burn the CDs or DVDs; sometimes images are lost in transit to the external vendor or external vendor is not able to open the archive so they have to be re-sent.
You can learn more about imaging requirements: Managing DICOM images: Tips and tricks for the radiologist
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 8 Dec 2015