Data collection for Tracking Parkinson's closed on 31 December 2022. All sites should begin the process of site close-out.
In accordance with our study protocol, the coordinating centre in Glasgow will be digitally archiving the Clinical Research Files (CRF folders) for all sites.
Sites are responsible for archiving their PI Site Files according to local procedures.
If your site has any serum samples stored in local freezers, please arrange to send these to the study biobank at Cardiff University.
Email a copy of the Serum Sample Coversheet to the Cardiff team, who will then arrange a courier to collect samples.
Glasgow is archiving only CRF folders, not PI site files.
CRF folders should not ever contain any identifiable information but please check each one and remove any patient-identifiable information and place it in your PI Site File or dispose of it appropriately.
Glasgow will provide shipping boxes if required. You do not need to remove paperwork from the folders, they should be shipped inside the plastic pockets and within the correct 3-ring binder.
After you have removed any identifiable information from the CRF folders you can pack them into boxes. You can normally fit 6-10 folders in each box.
Complete a Contents Sheet for each box, email a copy to Glasgow and place the original into the relevant box. Complete a shipping Master Sheet and email it to Glasgow.
We will arrange a courier to collect the boxes and send you labels.
Please tape the boxes up very securely and affix the courier labels to each box.
Move the boxes to the agreed collection point.
Scanned CRFs will be archived by Sponsor with the CI Site File.
If your site requires a copy of the scanned CRFs for your PI Site File, we can send these to you via secure file drop-off.
If your Trust will not allow central digital archiving of CRFs, you must return a Protocol Deviation form before finalising close-out.
After you have prepared your PI Site File for Archiving, complete an Archiving Certificate and return it to Glasgow.
Once you have returned your archiving certificate, study close-out is complete and you can archive your PI Site file for at least 15 years, per study protocol.
For all your work on Tracking Parkinson's over the last twelve years.
Print 