The Sponsor: The Sponsor: Responsibilities in Medical - PowerPoint PPT Presentation

The Sponsor: The Sponsor: Responsibilities in Medical Responsibilities in Medical Device Clinical Trials Device Clinical Trials Presented by Catherine Parker, RN Presented by Catherine Parker, RN Consumer Safety Officer Consumer Safety Officer Division of Bioresearch Monitoring Division of Bioresearch Monitoring Office of Compliance Office of Compliance Center for Devices and Radiological Health Center for Devices and Radiological Health

Objectives Objectives Define “medical device research � Define “medical device research � sponsor.” sponsor.” � Identify the 10 sponsor responsibilities � Identify the 10 sponsor responsibilities discussed in the presentation. discussed in the presentation. � Contrast the role of monitoring with the � Contrast the role of monitoring with the role of a Data Monitoring Committee. role of a Data Monitoring Committee. Identify the six categories of records � Identify the six categories of records � sponsors may be required to maintain. sponsors may be required to maintain.

Presentation Topics Presentation Topics � Regulatory Definition of a Sponsor � Regulatory Definition of a Sponsor � Sponsor Responsibilities � Sponsor Responsibilities � Monitoring � Monitoring – Monitoring vs. Data Monitoring Committee – Monitoring vs. Data Monitoring Committee � Sponsor Records � Sponsor Records � Documentation � Documentation � Inspections � Inspections � Sponsor Reports � Sponsor Reports

A Sponsor I nitiates a A Sponsor I nitiates a Study Study 21 C.F.R. 812.3(n) 21 C.F.R. 812.3(n)

A Sponsor is a Person A Sponsor is a Person 21 C.F.R. 812.3(l) 21 C.F.R. 812.3(l)

General Sponsor General Sponsor Responsibilities Responsibilities 21 C.F.R. 812.40 21 C.F.R. 812.40 � Select qualified � Select qualified investigators investigators � Provide them with � Provide them with the information the information they need to they need to conduct the study conduct the study

General Sponsor General Sponsor Responsibilities Responsibilities 21 C.F.R. 812.40 21 C.F.R. 812.40 � Ensure proper monitoring � Ensure proper monitoring � Ensure IRB review and approval � Ensure IRB review and approval � Submit IDE application to FDA � Submit IDE application to FDA � Ensure IRB and FDA are informed of � Ensure IRB and FDA are informed of significant new information about an significant new information about an investigation investigation

Sponsor Responsibilities Sponsor Responsibilities 21 C.F.R. 812.43 21 C.F.R. 812.43 � Ship investigational � Ship investigational device(s) only to qualified device(s) only to qualified investigator(s) investigator(s) � Obtain signed investigator � Obtain signed investigator agreements and financial agreements and financial disclosure from all disclosure from all investigators investigators � Select qualified monitors � Select qualified monitors

Monitor Monitor 21 C.F.R. 812.3(j) 21 C.F.R. 812.3(j) � An individual � An individual designated by a designated by a sponsor or CRO to sponsor or CRO to oversee the progress oversee the progress of an investigation of an investigation � It is a sponsor’s � It is a sponsor’s responsibility to select responsibility to select monitors that are monitors that are qualified by training qualified by training 21 C.F.R. 812.43(d) 21 C.F.R. 812.43(d) and experience and experience

Monitoring Monitoring 21 C.F.R. 812.3(j) 21 C.F.R. 812.3(j) � The act of overseeing the progress of � The act of overseeing the progress of an investigation. an investigation. � Used to assure the protection of human � Used to assure the protection of human subjects and data integrity subjects and data integrity � Ongoing continuous process � Ongoing continuous process � The task of monitoring can be delegated � The task of monitoring can be delegated but, it is ultimately the sponsor’s but, it is ultimately the sponsor’s responsibility responsibility

Monitors Review Monitors Review � IRB approvals � IRB approvals � Informed Consent Documents � Informed Consent Documents � Source documents � Source documents � Case Report Forms (CRF) � Case Report Forms (CRF)

Monitoring I nvestigations Monitoring I nvestigations 21 C.F.R. 812.46 21 C.F.R. 812.46 � Secure investigator compliance � Secure investigator compliance � Conduct an evaluation of any � Conduct an evaluation of any unanticipated adverse device effects unanticipated adverse device effects � Obtain FDA and IRB approval before � Obtain FDA and IRB approval before resuming a terminated study resuming a terminated study

Monitoring vs. DMC Monitoring vs. DMC Data Monitoring Committee (DMC) Sometimes referred to as a Data and Safety Monitoring Board � Monitoring is a different process then � Monitoring is a different process then oversight by a Data Monitoring oversight by a Data Monitoring Committee Committee

Data Monitoring Committee Data Monitoring Committee � A group that reviews data from a trial � A group that reviews data from a trial � They advise the sponsor regarding the � They advise the sponsor regarding the continuing safety of trial subjects continuing safety of trial subjects � Evaluate data for continuing validity and � Evaluate data for continuing validity and scientific merit scientific merit

Sponsor Records Sponsor Records 21 C.F.R. 812.140(b) 21 C.F.R. 812.140(b) � All correspondence � All correspondence with another sponsor, with another sponsor, monitor, CI, IRB, and monitor, CI, IRB, and FDA FDA � Shipment and � Shipment and disposition of the disposition of the device device

Sponsor Records Sponsor Records 21 C.F.R. 812.140(b) 21 C.F.R. 812.140(b) � Shipment � Shipment – Name and address of – Name and address of consignee consignee – Type and quantity of device – Type and quantity of device – Date of shipment – Date of shipment – Batch number or code – Batch number or code � Disposition � Disposition – Batch number or code – Batch number or code – Reasons for – Reasons for – Method of disposal – Method of disposal

Sponsor Records Sponsor Records 21 C.F.R. 812.140(b) 21 C.F.R. 812.140(b) � Signed investigator � Signed investigator agreements & agreements & financial disclosure financial disclosure information information � Non-significant risk � Non-significant risk device records device records 21 C.F.R. 812.140(b)(4) 21 C.F.R. 812.140(b)(4)

Sponsor Records Sponsor Records 21 C.F.R. 812.140 21 C.F.R. 812.140 � Adverse device effects � Adverse device effects and complaints and complaints � Other records required � Other records required by FDA by FDA

Sponsor Records Sponsor Records 21 C.F.R. 812.140 21 C.F.R. 812.140 � Retention period is 2 � Retention period is 2 years after years after –end of the study –end of the study –pre-market approval –pre-market approval application application � Custody can be � Custody can be transferred transferred

Documentation Documentation If it is not documented, it never If it is not documented, it never happened. happened.

I nspections I nspections 21 C.F.R. 812.145 21 C.F.R. 812.145 � Permit access to FDA � Permit access to FDA � Permit inspection and copying of � Permit inspection and copying of documents documents

Sponsor Required Reports Sponsor Required Reports 21 C.F.R. 812.150(b) 21 C.F.R. 812.150(b) � Unanticipated � Unanticipated Adverse Device Adverse Device Effects (UADE) Effects (UADE) � Withdrawal of IRB � Withdrawal of IRB approval approval � Withdrawal of � Withdrawal of FDA approval FDA approval

Sponsor Required Reports Sponsor Required Reports 21 C.F.R. 812.150(b) 21 C.F.R. 812.150(b) � Investigator list � Investigator list � Annual progress � Annual progress report report � Recall and device � Recall and device disposition disposition � Final report � Final report

Sponsor Required Reports Sponsor Required Reports 21 C.F.R. 812.150(b) 21 C.F.R. 812.150(b) � Use of device � Use of device without informed without informed consent consent � Significant risk � Significant risk determination determination � Other reports � Other reports

Summary Summary � A sponsor initiates the investigation � A sponsor initiates the investigation � Sponsor responsibilities are designed to: � Sponsor responsibilities are designed to: – Protect human subjects – Protect human subjects – Promote the collection of quality data – Promote the collection of quality data

Summary Summary � A sponsor initiates the investigation � A sponsor initiates the investigation � Sponsor responsibilities are designed to: � Sponsor responsibilities are designed to: – Protect human subjects – Protect human subjects – Promote the collection of quality data – Promote the collection of quality data