Site Tips for Better Monitor Visits

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05 September, 2019 By Victoria Salas

Prior to the Monitor’s arrival:

  1. Let the monitor know what your monitoring hours are (how early they can get there and when monitor hours close). You may also want to have a copy of your monitor hours posted in the monitor room so they remember to wrap-up in time.

  2. Plan for smooth EMR access. If possible, ask the monitor to complete any applicable documents or training beforehand.

  3. Have all the data entered into the Case Report Form.

  4. If you have a private monitor room: set-up the monitor room in the morning before the monitor arrives. Layout the regulatory binder, source and have the monitor visit log ready for signature upon arrival.

  5. Make sure the monitor room/area has an outlet.

  6. Ensure all regulatory documents are filed accordingly. You should have all IRB approved documents easily accessible. Including: IRB approvals for all versions of the ICF document, protocol, IB (if applicable), advertisements, initial approvals and continuing reviews. Licensed study staff should always have current medical licenses filed. All study staff should have protocol and current GCP training documented and filed.

  7. All study logs should be complete and up to date. That goes for enrollment logs, IP and device accountability logs, adverse event logs, training logs and delegation logs.

  8. If a study participant experienced an AE or SAE ensure all related documents are filed accordingly and easily accessible.

  9. Print out a notice that lists which wi-fi network to use along with the password so the monitor doesn’t need to hunt down the study coordinator for this.

  10. Applicable study staff (such as the PI, CRC and/or Regulatory Associate) should arrange some one-on-one time with the study monitor during their visit.

  11. Address as many queries as possible to decrease the number of open action items after the visit.

When the monitor arrives:

  1. Include a quick tour if it is the monitor’s first visit. Point out where the bathroom is and where the breakroom or cafeteria is located. Note if you have a refrigerator that you allow monitors to store their lunch in.
  2. Let the monitor know the best way to reach the study coordinator or regulatory associate during the visit in case something comes up. Should he/she call your desk or send you an email?

You may also consider adding these items to your monitor space:

  1. Kleenex

  2. Welcome binder that lists some local restaurants in the area. As many monitors are constantly travelling they will appreciate some local recommendations. Your welcome binder can also include your wi-fi network information and monitor hours if you don’t want to post them on a wall

  3. A Survey Box – This can be something that management uses to stay in touch with how the monitor visits are going. Just a simple survey that asks how their visit went on a scale from 1 to 10, if they have any suggestions or maybe an option to note if they would like someone from management to contact them.

Finally, don’t forget to ask your study monitor if there are any studies in the pipeline that may be a good fit for your site! If you’ve put your best foot forward he or she will be happy to recommend your site for future studies.

Written by

Victoria Salas