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The following wording is suggested for study protocols and ethics applications:

Data Management

Data will be collected using the web-based REDCap system, stored on a secure password protected server at the coordinating centre. REDCap is HIPAA compliant and includes unique user identification, access level control and tracking logs. Data instruments or electronic case record forms (eCRFs) will contain appropriate range and logic checks to identify data entry errors. Single data entry will be performed but a data monitor will review each eCRF form completeness, raise data queries as required, and lock the form once all queries have been resolved. Data Access Groups will be used restrict access of data at each site to local investigators, co-ordinators and data entry personnel. Only the members of the central coordinating team will have access to full study data, including the investigators, and research staff appointed by the principle investigator. REDCap data will be backed up on a secure password protected server at the coordinating site, accessible only to investigators, server administrator, and project and data managers.

Confidentiality

The REDCap system will be stored on a secure password protected server at the coordinating centre. Access will be via the web, controlled by unique user ID and password, access level control, and with full electronic tracking log. eCRFs will Extracted data files will contain only de-identified data, with the exception of infant DOB and EDD, as these are necessary for analysis. Study presentations and publications will contain only summary data and individual participant data will not be reported. The study steering group or investigators, will be responsible for data access. Identifiable data will not be released to any third party.

At the completion of the study, all electronic data will be permanently digitally archived and accessible only to the principle investigators. Remaining hard copy records will be stored in a locked cabinet in a secure office, and will be accessible only to the principle investigators. Records will be retained for a minimum of 10 years after the age of majority. If a data sharing option is mandated by the publisher, only de-identified data will be released and its use will be strictly controlled by a data sharing agreement through the Maternal & Perinatal Central Coordinating Research Hub.

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