PBRN and practice representatives are essential members of the research project team, and involving them in all aspects of a clinical trial is important.

The PBRN central research project team members offer critical feedback and advice on how best to work with the member practices.

PBRN research project personnel vary depending on the particular PBRN and the specific clinical trial.

Responsibilities for PBRN research project personnel also differ for each trial, so clarifying who is responsible for which activities before the trial starts is important.

For most studies, a PBRN research project manager works closely with the academic research project team during all phases of trial implementation.

In some studies an on-site practice liaison/research project coordinator helps to facilitate implementation of the trial within a practice.

For a trial to run smoothly, creating a manual of protocol procedures that clearly outlines all trial procedures and provides simple, clear presentations of the work and workflow in the practice setting is imperative. Storing this manual in a secure manner that is accessible to all research team members is critical (see Table 5).

Developing a data-sharing agreement that addresses issues such as data ownership before the commencement of a trial is important. The data-sharing agreement should address how patient confidentiality will be maintained, including what information will be de-identified and how this will be accomplished.

Each trial should also use a regulatory binder to manage important documents. This binder contains the most recent version of the protocol, informed consent document, IRB approval letters, training documents of study personnel, a site personnel delegation log, and other study correspondence.

Ensuring quality requires detailed documentation of trial progress and maintenance of organized trial files.

A clinical trial quality management plan can help to make sure that all issues that affect trial quality are being appropriately addressed. Regular review of this plan is important.

Regular communication between the academic research project team, the PBRN on-site research project team, and the participating practices is key to keeping all team members engaged in the trial.

Offering opportunities for training and professional development is another strategy for keeping PBRN on-site research project team members engaged.

Understanding all the steps necessary for closing out a trial and clarifying who will be responsible for which steps is important.