Avoiding Headaches in IRB and EC Submissions and Approvals

Avoiding Headaches in IRB and EC Submissions and Approvals

By Rob Laurens on Thu, Mar 7, 2013

Robert Laurens Web resized 600Delays in your IRB or EC submission and review process can not only cause severe headaches for your clinical team members, they can wreak havoc on your patient recruitment campaign’s critical path. Or perhaps better said, an efficient IRB / EC submission management process can mean the difference between maximizing the return on your recruitment investment and your campaign being too little, too late to significantly affect your enrollment completion date.
Here are five basic tips that will help ensure your regulatory body submissions of patient recruitment materials are easy, exacting, and expedited: 

 

 

  1. Make sure the appropriate people know about your upcoming submission.
    Make sure the entity – most typically your CRO – and the individual who will be submitting your recruitment materials, are well aware ahead of time that you will be making a submission. Too often, sponsors overlook the fact that the submission of patient recruitment materials wasn’t anticipated by the CRO – especially in rescue situations. Making the submitter aware well ahead of time will help ensure proper time and attention is paid to facilitating a timely submission and review response. 

  2. Nail down your submission schedule well ahead of time.
    Obtain each IRB / EC review schedule so you can target a specific submission date and know when to expect approvals. Without it, you can’t plot your campaign rollout – or ensure the submissions happen on time.

  3. The point at which you’re ready for IRB / EC submission is not the time to take comments and feedback.
    Make sure anyone who has the power to delay the submission process is well aware that your materials have been reviewed and approved not only by your clinical team, but also by your company’s legal and regulatory departments. Too often, those facilitating submissions believe you want them to assess the content and messaging of your materials. While valuable suggestions are appreciated, there’s a time and a place to take feedback – during the development stage, before you go to your legal team. Work in your submitters’ review of the materials – and give them a specific deadline by which to provide their comments

  4. Have your IRB / EC track any changes or questions they may have.
    Most IRBs and ECs work via electronic documents nowadays. Ask them to provide comments directly on the materials, so that you can be sure of the edits or questions they may have, and the context in which they occur. This can save valuable time in turning around re-submissions.

  5. Go digital.
    Excel trackers are out of date the moment something changes with your submissions. Instead, use an Internet-based electronic patient recruitment management system to manage your submission tracking. These systems allow all submission information to be available to interested study community members the moment the information is updated. Tracking everything online eliminates confusion or lost detail that is inherent in the Excel approach. It also allows you to easily monitor and track actual submission progress vs. your original submission schedule (i.e., will increase the likelihood that submissions will be made, and approvals reported, on time). Learn more about patient recruitment management systems, such as BBK’s TrialCentralNet. 

There are other tips and techniques that can help maximize timeframes – from using expedited reviews to creating a user-friendly packet design that not only makes things easy on the reviewers, but also on your designers and copywriters when it comes time to layout your translated materials. But these core tenets are the essentials for properly managing and expediting your patient recruitment IRB and EC submissions and approvals. Without them, your clinical teams will be reaching for the aspirin – and possibly asking for an enrollment extension.
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Topics: BBK Worldwide, Patient Recruitment, Cultural Adaptation, Patient Advocacy