Agreements for review and line of effects
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
During the follow through, the participants might possibly be contacted from the research people. Notably, any participant which dropped of cures remain enjoy having search assessments and you may follow through.
Data management
Depending on the accepted data administration plan, study would be registered with the RedCap to your a secure room to the the fresh School host. This option lets full responsibility of data administration, and you can simple strategies come into place is always to difficulties arise. Most of the info are observed in the investigation government bundle, which is obtained from the primary investigator upon consult.
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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