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Since this situation could end up in court, having a complete record will be helpful.
A screening record will be kept to document criteria eliminating those deemed to be ineligible.
In addition, a record will be kept of all medication taken (corticoids, immunosuppressors, anticoagulants, etc).
A record will be kept of eligible patients who decline and reasons for declining.
In addition, a record will be kept of participation rates throughout the intervention and reasons for non-participation where possible.
A record will be kept of all coding discrepancies, and notes taken regarding the rationale for final coding.
A record will be kept of all articles excluded at this stage and the reason for their exclusion.
A record will be kept of practitioners who choose not to participate and where given, the reasons for their decisions.
Data records will be kept in a secure locked cupboard for a period of 30 years.
All paper records will be kept in locked filing cabinets, in a secure office at each of the investigation centres.
All records will be kept secure and confidential, and names will be kept confidential, regardless of the finding.
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