Email FAQs #2

Q: Whose responsibility is it to archive email messages? How do we make sure nothing gets forgotten?

A: As with many of these issues, best practice can be found by reference to approaches commonly adopted in a traditional, hard-copy environment. Prior to the common use of email, it was the study monitor’s responsibility to ensure that any trial-related communications – typically letters and memoranda – were filed in the trial master file. It was the responsibility of other recipients to check the distribution list on the document to ensure that the monitor was included. If he/she was included, all other copies were handled as “for information only”. If the monitor was not included on the distribution list and the communication was clearly trial-related, it was the recipient’s responsibility to ensure the document was filed in the trial master file. The same process should be followed for emails.

To facilitate processing, a de-personalised (or generic) email account for each study can be created. Then the sender (or in some cases, the recipients) should ensure that the corresponding study email account was included on the email distribution list.

For example: tmf_project_123@acme-pharma.com

Q: What kinds of policies, procedures and training are required for trial-related email use?

A: 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 place?

A: Develop standard naming conventions to identify email. Using standard terminology in the subject field of emails can significantly improve email filing, archiving and retrieval and will facilitate the use of automated tools (such as rules and auto-archiving routines) for email management.

Just as metadata – such as study number, country, investigator site – were included on the subject line of traditional, hard-copy letters, the same process should be for emails. Such systems should be documented and included in standard training courses for clinical staff.

Q: I copy all my emails onto CD for the archive. Is this acceptable?

A: .In some circumstances, CDs or DVDs may be a suitable archive medium provided all processes related to the archiving of emails, transfer of emails to other system and/or other media such as CD or DVD are documented in standard operating procedures. Such processes should be developed in conjunction with users, records management and IT personnel to ensure records are retrievable throughout their retention period.

It should be noted however that there is still some debate regarding the lifespan of CDs and DVDs. Whilst some accelerated ageing studies suggest a lifespan in excess of 70 years, others suggest a much shorter lifespan. In addition, the maintenance of back-up copies and regular integrity checking of the data is more onerous than for other electronic storage media. For these reasons, CDs and DVDs are not the first choice for archival storage though they may be suitable as a shorter-term solution for small organisations.

Clinical staff should not independently archive emails onto CD without prior consultation with the records manager/archivist and IT staff.

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