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Compliance In Focus
Posted by Stephani Hulec on Tue, Aug 20, 2013

Can Internal and External CRA's Work Together Efficiently?

How Can Internal and External CRA%27s Work Together EffectivelyAs a monitor working at a clinical research organization (CRO), we partner with sponsors who, many times, have their own internal clinical research associates (CRAs) involved with the same studies.  At the very least, each sponsor has a project manager for that trial.  Both the internal sponsor project manager and/or CRA and the external field CRA at the CRO want to work together to make monitoring the study as efficient and effective as possible.

However, this is sometimes easier said than done.  It seems as though the main hurdle between successfully working together is communication between the sponsor and monitor teams

Some issues noted in this article include:

  • Sponsors report that CRO personnel may not communicate “bad news” in a timely manner; therefore, sponsors become aware of issues too late in the process to effectively provide support and corrective action plans.
  • Sponsors may not always communicate their expectations of the CRO team up front, during the contract stages.  For example, how often will site visits be necessary, when data locks are anticipated, which SOPs the CRAs should follow, which of the sponsor’s tools the CRAs should use, etc.  If these are then communicated to the external CRAs at a later date, they may not be as willing or able to comply with the sponsor’s requirements.

In addition, both sponsors and CRAs have complaints that echo the issues above:

  • Sponsors may become frustrated, if they feel that they don’t have a firm understanding of what is going on with their study at the sites. This is caused by a lack of timely and accurate communicating from the external CRAs when problems are noted.
  • The field monitors experience the same lack of clarity from sponsors in outlining their expectations, roles, and responsibilities.
  • In addition, many times the internal project manager or CRA does not ask for input from the monitors; however, the sponsor may then micro-manage the monitors’ every move or may remain non-responsive for the most part- neither of which set the team up for success.

Improving communication between internal and external CRAs and, therefore, successful monitoring of the clinical trial, is necessary.  Some suggestions are noted here, here, and here as well:

  • Instead of CROs trying to work on issues noted at sites on their own, any problems should be communicated immediately to the sponsor CRA or project manager in order for everyone to be on the same page and work together towards the common goal (i.e. site compliance).  Any issues should be clearly documented in monitoring reports; in addition, monitors and sponsors should discuss site issues on a frequent basis, as needed, or at regularly scheduled meetings or phone calls.
  • Sponsors should be upfront and clear about their expectations.  The article above quotes “A true partnership…relies on open vendor input regarding trial plans, goals and endpoints, and any other relevant issues. To gather input, however, sponsors must maintain open lines of communication and a willingness to consider feedback, however unwelcome or uncomfortable it may seem at first.”
  • Expectations should be defined in any contracts between the sponsor and CRO, and should be outlined in a monitoring plan.  Discussion of the monitoring plan should occur between the internal and external CRAs at the start of a project, to clear up any confusing language as soon as possible.
  • Both internal and external CRAs should copy each other on any relevant communication with their sites.  Fostering this positive communication strategy builds trust amongst the team, which will only further enhance collaboration between both parties.
  • The sponsor CRA and the external CRA should be willing to support each other as needed throughout the course of the trial, by being available for discussions, questions, etc.
  • The internal CRA or project manager may be more responsible for noting data “trends” or study-wide issues; these would be much more difficult for an external CRA to determine, as they may only have a few sites for the particular study.
  • The external CRA should be responsible for being the “eyes and ears of the sponsor”.  This entails more than just reviewing subject data and regulatory binders; being on-site allows the CRA to communicate any “softer” information to the internal CRA, such as feelings for how the site communicates with each other, how they react to questions from the monitor, etc.

What other suggestions can be made to improve communication between internal and external CRAs?

Photo Credit: Trypode

Regulations Revelations

Topics: Internal CRA, External CRA, Clinical Research Organization, Sponsor

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