11.2
Source Data
Source data refers to where data are first recorded, and from which participants’ study data are obtained. Source documents include, but are not limited to, hospital records (from which medical history and previous and concurrent medication may be summarised), clinical and office charts, laboratory and pharmacy records, diaries, radiographs, correspondence and audio recordings. Study data will be collected into a CDMA, in which entries will be considered source data if the CDMA is the site of the original recording (e.g. there is no other written or electronic record of data). It is the intention of the Sponsor to capture as much study related data as possible (including informed consent) using e-source, through direct data capture into a REDCap-based CDMA. REDCap is a secure, HIPAA (United States Health Insurance Portability and Accountability Act 1996) compliant webbased application designed to support data capture for research studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages, including de-identified data sets; and 4) procedures for importing data from external sources.52,53 Where it is not possible for source data to be captured via direct data capture, investigators will transcribe the data from the source into the CDMA.
11.3
Electronic Case Report Form (eCRF) Data
An eCRF (an application held in REDCap) will hold data that is required for analysis. Specified data held in the CDMA will be pulled through to the eCRF. During the process of the data pull, the data from the CDMA will be rendered non-identifiable, with each participant identified by a unique study ID within the eCRF.
11.4
Access to Data
Direct access to source and study data will be granted to authorised representatives from the Sponsor, and the regulatory/ethics authorities to permit trial-related monitoring, audits and inspections. Investigators will have continuous access to the source data they have entered into the CDMA. The investigator and site retain ownership of the data they have entered. The Sponsor will have access only to data held within the eCRF, with the exception of the delegated study monitor(s), who will have access to source data held in the CDMA, for the purpose of enabling trial-related monitoring. Sponsor REDCap Administrators may technically access the CDMA data, as their access is unrestricted. Administrators will not access the CDMA except where specifically required to do so. The system audit trail will record Administrator access to CDMA data and this will be checked as part of Sponsor monitoring activity to ensure compliance.
11.5
Record keeping
Data contained within the CDMA and eCRF will be held on Sponsor controlled secure servers, hosted by Amazon Web Services, located in Sydney, Australia. Summarised trial related data (not containing any particpant identifiable data) may also be held on Sponsor controlled secure servers in NZ, and Sydney or Melbourne, Australia. The following records will be stored/ archived for 10 years after the youngest child in the study turns 16 years old or 15 years after the completion of the trial, whichever is longer:44
Source and essential documents Study data held within the eCRF Essential documents held in the Trial Master File (TMF)
Investigators may continue to access data held within the CDMA after database lock/ data archive has occured. The data will be read-only to prevent unauthorised changes. Access requests will be facilitated by the Sponsor, including access in the case of a regulatory audit.
CONFIDENTIAL
Protocol: Children’s Anti-Inflammatory Reliever
Version 4.1 (04/02/2022)
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