Axiom Remote Protocol Management

RPM-Logo

Axiom’s Remote Protocol Management (RPM) program provides professional and cost effective, outsourced research compliance to institutions of all sizes. Our goal is simple: to provide efficient and high quality reviews of IRB applications. In doing so, we can please investigators with quick turn around times and make your IRB run smooth and efficiently, while maintaining the highest standards of protection of human subjects.

 

A Trusted and Knowledgeable Partner.

With a staff of experienced research compliance Review Specialists, we have the knowledge and best practices to support our clients with impeccable service levels and responsiveness.

  • Entirely U.S. based compliance support services
  • Rapid determination reduces wait times and improves researcher satisfaction
  • Low costs per review
  • Rapid routing based on client policies and procedures
  • Multi-level support for increased efficiency
  • Quality review to monitor Review Specialist accuracy and engagement

When researchers work within an efficient, effective and supportive compliance program your institution wins with happy researchers, full regulatory compliance, and rapid award-to-payment for grants.

 

Working Together to Understand how RPM can Benefit Your Institution. The first thing we do is meet with the you to understand your review processes and set out a division of labor between Axiom RPM and your research compliance staff and IRB chair. We review your policies, practices and culture to understand what is important to your IRB. We will make recommendations to streamline the workflow, but all policies and procedures are determined by you – the client. We develop a checklist based on your practices for our reviewers to follow in reviewing each new protocol or protocol report.

Once we have established a division of labor between Axiom RPM and the client IRB, we provide to the client the CV/Resume of professional Review Specialist(s) assigned to them. We never add a reviewer without your explicit approval.

What kinds of services do the RPM Review Specialists provide? Our professional staff can manage the pre-review process to ensure new submissions are complete prior to review by your IRB or prior to assigned review by the client IRB members. Review Specialists can handle all administrative aspects including:

  • assignment of reviewers
  • management of the meeting agenda and minutes
  • correspondence with the investigators including
    • revisions,
    • approval notifications and
    • follow up on all pending items including requests for revisions that are past due, delinquent continuing reviews, and administrative terminations.

Can RPMs reviewers do approvals? Yes. Our Review Specialists are experienced research compliance professionals and can handle Exemption determinations as well as Expedited approvals, including expedited approvals of continuing reviews and amendments. In order for our reviewers to do Expedited approvals, you must add our reviewers to your IRB membership as backup/alternate members (and update your FWA if you have one).

How is Axiom RPM different from a commercial IRB? Axiom RPM provides reviewer services to existing IRBs. Our reviewers work for your IRB. Your IRB retains control over the reviewer process and maintains ultimate responsibility for the protection of human subjects at your institution.

All Data is Entered and Tracked in Axiom’s Mentor IRB Software Platform. The Mentor system is an online platform for research compliance review and reporting. With Mentor, there is no physical infrastructure on your site, so there are no hardware or software upgrades for your IT staff to manage.  We host Mentor in Amazon Web Services, the largest and most secure cloud computing environment in the world. We manage security, data backup, disaster recovery and all upgrades of the Mentor system.

Your investigators enter submissions in Mentor using the intuitive, responsive interface. The submission is then sent to your Axiom RPM Review Specialist. Each of our Review Specialists has worked with the Mentor system and knows its processes and procedures. They are power users so they know how to leverage all of its features to improve performance.   The Review Specialist then does a pre-review using the client checklist to confirm compliance with institutional policies as well as federal regulations. The reviewer will forward required revisions back to the investigator and then periodically follow up with investigators who have not responded to requested revisions within a specified period of time.

Based on the client polices, your Review Specialist will generate the agenda for each IRB meeting with the appropriate items on the agenda for full board review. They can also construct a special agenda to report out all exemption determinations and expedited approvals.

Our Review Specialists: Over the years of providing Axiom’s Mentor software we have come to know some excellent research compliance staff, individuals who understand the regulations, have a great work ethic, care about research and know how to communicate with investigators. They have worked with students, faculty, nurses, physicians and research staff and know-how to the get the job done.

Do we have a single point of contact with Axiom Education’s RPM? Yes, your Review Specialist is your single point of contact.   Additionally, you will be have access to Curtis Naser, Ph.D. Curt manages the RPM staff. The client or Review Specialist can forward any concerns or issues that arise to Curt, who will in turn work with the IRB Chair or other staff member to resolve the issue. We use the Mentor protocol messaging system to handle all protocol related correspondence so that there is an audit trail of all decisions and discussions. And your IRB Chair and IRB support staff have full access to the Mentor IRB system so you can monitor activity on any protocol at anytime.

Do Axiom RPM reviewers attend our IRB meetings? Not in person unless specific arrangements have been made in advance. They can attend by conference call.

How is Axiom RPM different from a commercial IRB? Axiom RPM provides reviewer services to existing IRBs. Our reviewers work for your IRB. Your IRB retains control over the reviewer process and maintains ultimate responsibility for the protection of human subjects at your institution.

What is the cost for the Remote Protocol Management Services?

We provide a RPM-Logo(Text-Only)straightforward pricing program.  The chart below outlines our basic pricing model.  Costs may vary depending upon the specific tasks you assign to our reviewers and there may be different specifications you set that will alter pricing. Contact us so that we can determine the best program for your institution.

Service Price/Item
Exemption Determinations $30
   With consent form revisions $50
Expedited Approval $250
Continuing Review Approval $30
Expedited Amendment Approval $30
Full Board Pre-Review $250
Expedited Pre-Review (without Approval) $200

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