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Sheep in a field with a sunset behind them ©

Trial Managers wear many hats and require lots of different skills. The data hat is central to the success of the trial.

Bad data = bad analysis = inconclusive result = poor trial...

A good trial manager knows this and can view the trial from a data perspective. They will know what data is critical, and they will keep an eye on it.

In NDORMS data management, is centralised, we don’t have a dedicated data manager for any of our trials. So, trial managers need to have a good understanding of their trial data. The best analogy, I have heard is that a trial manager is like a shepherd and each participant is one of your sheep. As the shepherd you need to know where your sheep are, and if one goes missing you need to look for it and bring it back into the fold. Some sheep may have wonky legs and so will need more care. Ref. DB. When help is needed to care for your sheep, the data management team, and supporting staff will assist and offer guidance.

10 Habits of a good  trial manager:

  1. The most important thing they do is communicate, regular Data Management meetings, are the chance to let us know what is happening and any challenges. Invite us to your TMG, and give a heads up if any meetings are concerning data changes.
  2. Keep track of participants, know their key follow-up dates, and anything unexpected like delayed operations.
  3. They are aware and mindful of their primary and secondary outcomes, and the timepoints when these occur.
  4. Understand the importance of reporting data status at TMG meetings, so that issues can be managed early e.g. if follow-up percentages are low, the whole team is aware, and it can be addressed as a group.
  5. Respect data management team advice, especially with respect to standard processes.
  6. Do not operate as an island, shutting out help to manage the data e.g. even if you have systems that you have used in previous trials, it is important that we use similar processes so that if you are no longer available other people can manage the data.
  7. Inform us about any changes in your trial that will affect the data, or systems that are used to collect it.
  8. Collaborate, come up with ideas, and embrace changes that make data management and collection easier for us, sites or participants.
  9. Understand that if it’s not in the data it didn’t happen e.g. deviations, withdrawals
  10. Love your data management and support team, not overtly, just the occasional bribe or a simple compliment.