What kinds of policies, procedures and training are required for trial-related email use?
It is common practice for clinical staff to attend training courses on a variety of GCP-related topics throughout their clinical careers. Good record-keeping is critical to achieving GCP compliance, so we recommended that such training programmes include all relevant aspects of record-keeping, including the proper use of electronic mail. All staff must be made aware that any email message has the potential to be an official company record and could be the subject of an inspection and/or litigation discovery. Formal rules and procedures should address the naming of emails; what email should and should not be used for; best filing practices; email archiving. These rules and procedures should be documented in an official company policy and taught to employees in mandatory training sessions. Internal audits and inspections should include an assessment of compliance with email policy. Q: How do we make sure an email gets filed properly in the appropriate trial master file and in the right p
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