Study Documents for Researchers
Describe the application process to access the data.
At the trial’s conclusion, de-identified datasets will be prepared for use by other researchers. Data from both the main REDCap database and the MAC App database will be made available. Data sets for dissemination will be hosted on the publicly accessible CAM:IDE Data Access Portal and the link to the portal can be cited in publications, correspondence, or links can be displayed on other websites. The data will continue to be held on University of Cambridge infrastructure.
State the data transfer process
The Portal provides a straightforward, semi-automated application process. A landing page gives an overview of the project with download links for the protocol and other documents. From here a list of available data are displayed with a description of each individual data set. Those applying to access the data select the datasets required and are directed to a ‘light touch’ application form which asks:
- Name
- Institution
- Brief description of planned analyses (150Â words)Â Â this is configured for each project so Attend Team will need to advise
Applicant will be asked to read and agree to the Terms and Conditions before submitting. Submitting the form triggers an automated email to the designated reviewers (this can be 1 or more people and they system can be set to approve if a threshold of reviewers are happy eg. 4/6) . The reviewers log into the portal and will be able to view the list of requested data sets and application form. They are presented with ‘Approve’ or ‘Reject’ options and a comments box. Once approved, the system sends an automated email to inform the applicant who may now login to the download area of the Portal and see download links for the requested datasets. These links are time limited and expire after 30 days.Â
Clarify whether participant consent for future secondary use of data has been or will be obtained.
 The Consent Form contains a clause to cover the sharing of data with other researchers, as described in the Participant Information Sheet:
- I agree that my de-identified research data from this study will be kept in the long-term, may be combined with data from other studies to answer new research questions, may be shared with other researchers or may be made ‘Open’ (shared with other investigators or the general public) without new consent being sought from me. The details, results and implications of these other studies are unknown.