3 Tips to Prepare for Your Clinical Site Monitoring Visit

It is of utmost importance to be prepared before accepting a clinical research associate (CRA) at your clinical site for monitoring.  The impression of a CRA can not only impact your on-going trial but it could impact future business as a clinical trial site.  Therefore, these visits are not to be taken lightly.  If the CRA visit is not the first, you should review the last monitoring visit follow-up letter and make sure you have either addressed or have a plan to address any unresolved issues that were indicated in the letter.  We also want to share some other tips with you to help ensure a successful and constructive CRA clinical trial monitoring visit.

Organize your team

Schedule the visit and subsequently ensure that your clinical team is available on the day of the clinical trial visit.  This includes:
  • The clinical trial coordinator who will greet and host the CRA

  • The principal investigator, as normally the CRA will likely spend about 30-60 minutes interviewing the PI.

  • Supporting staff

  • The pharmacist that they will need to complete and have available the pharmacist binder.

Free ebook download: Learn the 4-step process that simplifies the site  budgeting process.

 

Collate all data associated with the trial

Try to save yourself and the CRAs time by having all the clinical trial data collated and available on site and ready for review. These include:
  • Patient records

  • Completed documentation indicating procedures performed per the study protocol

  • Informed consent forms

  • Any supporting regulatory documentation

  • Information of the product being investigated including temperature, dispensing and accountability logs

Monitor clinical trial sites physical space

The overall ‘look and feel’, as interpreted by the CRA, is often overlooked but it will affect their perspectives on the of the clinical trial site capabilities.  So be sure to have the space look clean and organized. Here are some other items to consider.
  • Check that the equipment used is calibrated and in good standing.

  • IP/source documents are in locked storage facilities

  • There are limited access areas

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