Every Email is an Essential Document…or perhaps not

every email is an essential document

Wait, you said I shouldn’t file every email?

Please, no, for the love of all that is Holy, don’t file every email. I currently manage 15 sites and as a general rule, only about 1 in 10 emails I generate end up in the correspondence tab. This is because I do a lot of back-and-forth emailing with my sites. I never file the first email, just the final thread with the conversation trail included, assuming it is worth filing.

Do not file every email

Items that are worth filing reference clarifications, demonstrate training and oversight, address GCP issues, discuss protocol deviations, and document conversations involving the Medical Monitor. I have trained all my coordinators on this and when I go to monitor the correspondence tab is nice, slim, tidy, relevant, and useful.

Emails that probably do not need to be filed:

  • “Happy Birthday to your administrative assistant!”
  • “Ordering pizza, do you prefer veg or meat?”
  • “Have a nice weekend!”
  • If I am sending my site PK tubes and I email them tracking information, then they write back to say they received the tubes, then I look in the lab database and see that indeed, they did complete the required PK draws, this conversation really does not need to be filed.
About The Author

The Lead CRA

Nadia started The Lead CRA blog in 2007. She is now lead author for ClinOps Toolkit. Nadia is currently working as a Clinical Program Manager at a small specialty pharmaceutical company in the San Francisco Bay Area. You can reach Nadia via email at [email protected] anytime.

2 Comments

  • Matthew

    September 20, 2012

    Here’s a question… I’ve raised this issue at work (I am a CRA for a pharma/IVD mfr) when it’s time to update our SOPs. I’ve been told that the regs/guidance (CFR and ICH) do not say “relevant” communication. I am struggling to find evidence to support my claim that the Master Files | Correspondence Folder need only “relevant” correspondences. Anyone have a suggestion for a CRA who’s drowing in “Hi, have a great week” emails? (We have to print, sign, and date each one, scan one for the computer file, and then file the original in a mahoooosive filing cabinet!!!)

  • PRT

    June 24, 2011

    Best advice ever!!

    I can’t believe some of my colleague file every one of their emails with their sites.

    For me, that would be a nightmare to reconcile at the end of the trial.

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