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Study Requirements


Investigator Sponsored Study Requirements

What is an Investigator Sponsored Study (ISS)?

Please note that an investigator sponsored study means that you and your institution (where applicable) are responsible for fulfilling the obligations of both a study sponsor and an investigator. While Davol Inc. will provide financial support for the study according to a defined contract, you are the sponsor of the study.

What does it mean to be the sponsor of a study?

As the sponsor of the study, you are responsible for overseeing the entire conduct of the study and day to day operations which include: securing adequate resources available to conduct the study, authoring protocol and consent forms, IRB approval, managing study related documentation, data collection, data analysis, regulatory reporting, and publication.

As the sponsor of the study, the investigator must ensure that the study is conducted in accordance with the terms and conditions of the ISS contract, provisions of the relevant device regulations and all applicable local and regulatory requirements. The Sponsor- Investigator is legally responsible for compliance with regulatory and contractual requirements, including, but not limited to, obtaining IRB/EC and, regulatory (where applicable) approvals, and any and all reporting obligations to local Regulatory Authorities.

The Sponsor-Investigator will comply with recognized ethical standards concerning publications and authorship, including the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, www.icmje.org, established by the International Committee of Medical Journal Editors (ICMJE).

To learn more about your responsibilities as a sponsor, there is information available online at the following public websites:

Good Clinical Practice:
http://www.fda.gov/ohrms/dockets/ac/04/briefing/4028B1_08_GFI-ICH%20E6.pdf

Code of Federal Regulations 21:
http://www.fda.gov/medicaldevices/deviceregulationandguidance/databases/ucm135680.htm

ICH Guidance Documents:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122049.htm

What are my obligations if my research proposal involves studying a device for an indication or a specific patient population that is not approved within the current product label (i.e., off-label?)

It is important to be aware that a submission involving a device or study population that is not consistent with current device labeling indications (i.e. off-label use of marketed devices) will require an Investigational Device Exemption application (IDE) to the U.S. Food and Drug Administration (FDA) or local regulatory equivalent and approval by the agency prior to initiating the study. Please visit www.fda.gov for further information on this process.

If my research proposal is approved, what else do I need to do before I can begin the study?

Prior to commencement of an approved study, BARD requires 1.) a completed clinical study agreement (contract) and 2.) proof of Institutional Review Board (IRB) or Ethics Committee (EC) approval.

Davol will send you an initial draft of the clinical study agreement once approval is granted for your research proposal. The clinical study agreement or contract will include specific milestones for payment and will require submission of invoices with sufficient information to allow Davol to determine that milestones have been met.

Davol encourages you and your institution to add your study to the FDA's ClinicalTrials.gov database (www.clinicaltrials.gov) or a trial registry website in your country. Please note that this may be a prerequisite for publishing in select journals. The ICMJE requires study registration prior to first subject enrollment.

What are my responsibilities to the company during the conduct of the study? 

During the conduct of the study, any protocol amendments should be submitted along with IRB/EC approval.

BARD also requires regular updates (every 3-6 months) regarding enrollment and publication plans. Any planned publications must be sent to BARD as specified in the ISS contract.

In addition, if the device under study is a marketed device, The Sponsor-Investigator must report any device mechanical failures, malfunctions and defects and/or device-related adverse events to our field assurance team either by phone, fax, or email:

Telephone Number: 1-800-556-6756

FA Department Fax: 1-401-825-8754

Field Assurance Department
e-mail: Davol.FieldAssurance@crbard.com

Telephone: 1-800-556-6756

Sarah Hardy – Ext 8422
e-mail: Sarah.Hardy@crbard.com