Data collection and management
All relevant information related to the reliability and validity of the outcome measures are provided under assessments <12>. All interviewers, assessors and raters are extensively trained in the relevant assessment procedures, and reliability is checked continuously. All data are collected in a secure online system, which assures privacy protection and data integrity, as described in the data management plan (see below).
Plans to promote participant retention and complete follow up
From the follow up, the players was called by the look group. Notably, people new member exactly who decrease off cures will always be greeting having search tests and you can follow up.
Data management
With respect to the accepted data administration bundle, research would be entered to your RedCap toward a safe space with the the fresh new School host. This choice lets complete accountability of information administration, and you will important measures are in place is to difficulties arise. The details are found on the studies administration bundle, and that’s obtained from the primary detective through to demand.
Confidentiality
Data safety is guaranteed by the system’s security check and no formal data monitoring committee is requested. Participants’ personal information will be stored at a separate, locked, location at the Department of Psychiatry. No personal information will be revealed before, during or after the trial (except in the case of audit by the competent Ethics Committee; plans to give access to the protocol, participant level-data and statistical code are described in the data management plan; see <31c>).
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use
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