Requirements after Approval
After notification of approval of your research application, there are several requirements that the Principal Investigator and/or Institution must complete before funding and/or device delivery can be initiated.
AMS requirements include, but are not limited to:
- IRB/Ethics Committee approval as evidenced by an approval letter to the Principal Investigator
- Fully executed ISR agreement
- Final study protocol*
*AMS reserves the right to reconsider its decision for support if the final protocol is significantly different from the protocol submitted with the application.
Study Management Considerations and Requirements
American Medical Systems, Inc. recognizes and supports the vital role medical research plays in generating valuable scientific and clinical information that leads to innovative treatments, improved health care delivery, improved clinical care, and other advances that benefit patients specifically. AMS encourages you and your institution to add your study to the FDA’s ClinicalTrials.gov database or the trial registry in your country.
Regulatory and Ethical Obligations
As the sponsor of the study, the investigator and/or institution must ensure that the study is conducted in accordance with all applicable local, regional, and national laws and regulatory requirements. The Principal Investigator must assume all regulatory responsibilities including, but not limited to, IRB/EC approvals, regulatory approvals, and any and all reporting obligations to the regulatory authorities.
Safety Reporting Requirements
AMS has an ethical and legal responsibility to ensure the safety of patients. The Principal Investigator and Institution are solely responsible for any and all safety reporting and regulatory obligations associated with the conduct of the study as well as for designing and executing an appropriate plan for the oversight of patient safety during the study.
Study Status Updates
AMS requests status updates at least quarterly. Updates are expected to include information on status of study milestones which may include enrollment status (if applicable), study completion, projected publication dates, and any changes to the protocol. If there is any amendment to the original protocol after the research has begun, AMS requires notification.
At the close of the study, the Principal Investigator responsible for the study will be required to report the final study results in accordance with the ISR agreement.
AMS is offering institutions and physicians the opportunity to add to the body of evidence through their independent research. A wide collection of independent clinical research improves the integrity and thoroughness of the evidence. It also provides opportunities for physicians to research in new geographies, employ novel study designs, and to explore new solutions.
AMS supports the Principal Investigator in publishing the results of the study, whether or not the results are favorable to AMS products. The Principal Investigator is expected to comply with the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, www.icmje.org, established by the International Committee of Medical Journal Editors.
Financial Disclosure by AMS
In order to comply with government regulations and in the interest of transparency relating to its financial relationships with investigators and study sites, AMS will publicly disclose the funding associated with an ISR Agreement. For more information please click on the following link which will take you to the Physician Payment Sunshine Provisions.