Study Initiation

Upon final approval, a letter will be sent to the primary Investigator detailing the support being offered.  Prior to initiating research, the Investigator will be required to ensure that all of the procedural items are completed and that the required documentation has been sent to Cyberonics.  Expediting these items is essential to a timely initiation of support for approved research collaborations.  These items include:

• Final proposal (addressing any questions/issues by the Clinical Review Committee)
• Fully executed Research Agreement
• Copy of IRB or IACUC approval
• Current institutional W-9 form
• Study initiation visit by MSL or Cyberonics representative

Be sure to check the Post-Marketing Study Document Checklist to ensure that you have completed all the necessary tasks.

For the purpose of tracking patient enrollment (according to the Research Agreement) please fax or email the enrollment log form to your designated Cyberonics clinical project manager on a quarterly basis. A template enrollment log, that you are encouraged use is available here.  You will be compensated as specified in the Research Agreement.

Reporting of any potential Adverse Device Effects, SAE’s or Device Related Failures should be reported utilizing the established system for all commercial VNS Therapy implants by contacting Clinical Technical Services at 281-228-7330.  For your convenience the Medical Device Reporting requirements as specified in 21 CFR 803.3.

Back to: Submission Process Flowchart