Arrangements having research and collection of outcomes
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
At follow-up, the participants would-be called of the lookup team. Notably, any new member which fell out of procedures will still be welcome to own look tests and you will follow-up.
Data management
According to approved analysis management package, data could be inserted on the RedCap with the a safe space on the the newest University servers. This choice lets full responsibility of data government, and fundamental tips can be found in set will be trouble occur. The details can be found about analysis administration package, which is obtained from the primary investigator up on request.
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
