University of Minnesota IDE Sponsor or Sponsor-Investigator · University of Minnesota IDE Sponsor...

University of Minnesota IDE Sponsor or

Sponsor-Investigator

Registration Checklist and Self-Assessment

Provide Basic Information

☐ Principal Investigator (PI) basic information:Preferred First Name: ___________ Last Name: _________________U of M Internet ID: _______________Phone Number: ________________

Please attach the PI's Curriculum Vitae (CV). Attached:

☐ Yes ☐ No

☐ If the Principal Investigator is not also the Regulatory Sponsor, provide informationfor the University of Minnesota faculty Regulatory Sponsor.Preferred First Name: ___________ Last Name: _________________U of M Internet ID: _______________Phone Number: ________________Please attach the Sponsor's Curriculum Vitae (CV). Attached:

☐ Yes ☐ No

☐ Alternate contact (optional, if you prefer another person to be your main point ofcontact, such as a coordinator):Preferred First Name: ___________ Last Name: _________________U of M Internet ID: _______________Phone Number: ________________

University of Minnesota IDE Sponsor or Sponsor-Investigator Registration Checklist and Self-Assessment

Report Date

Provide Project Identifiers

☐ Current project descriptor – drug, device, biologic, tobacco, GRAS* or foodfor therapeutic use, medical device, combination product, IDE/IND exemption or determinationrequest, other situation involving FDA correspondence. Specify: ____________________

☐ Stage of the project – Sponsor's NSR IDE determination or existing FDA assigned numbers(examples - IDE, pre-IDE, email correspondence, transcript of telephonecorrespondence): ____________________________________

☐ Have you done other work with this product?☐ Yes, IRB Study Number(s): _____________________☐ None.

☐ Is the investigational product provided by (check all that apply):☐ Pharma or device manufacturer. If yes, name: ______________________☐ Another academic or non-profit organization. If yes, name: _____________☐ Manufactured at the University of Minnesota.

If yes, which facility: ________________If yes, do you plan to charge for the investigational product?: ______

☐ Does your study involve multiple sites?If yes, list sites: ___________________________________________

Provide Project and Sponsor Documentation

☐ 1. Submit all relevant FDA correspondence (if applicable) to the HRPP Central File.

☐ 2. Provide draft agreements with other study sites for multi-site investigations, ifapplicable. Provide manufacturing or Quality System descriptions.

☐ 3. Provide an agreement document delegating authority for Clinical and TranslationalScience Institute (CTSI) monitoring or another monitoring service accepted by CTSI.

☐ 4. Fill out the required Sponsor or Sponsor-Investigator worksheet below(complete the sections applicable to your research). You may include additionalinformation in the comments section. Please note Sponsor sections apply toSponsors and Sponsor-Investigators. The Investigator sections do not apply toSponsors who are not also Investigators.

Attestation:

Sponsor or sponsor-investigator certifies this document and attached self-assesment are complete and accurate to the best of their knowledge.Signature: _______________________ Date:_____________

*Generally Recognized as Safe by FDA


Report Date

Complete if you are a Sponsor. SPONSOR RESPONSIBILITIES – Significant Risk IDE (SR IDE) Regulations Corresponding Onsite Documents Response TRAINING Completed the UMN required reading for Sponsor-Investigators

Accessibility link: https://www.fda.gov/about-fda/about-website/internet-accessibility

MAINTAIN AN EFFECTIVE IDE (consult with University of MN and consider using their services for document preparation assistance, application review, and maintenance of an active IDE)

Protocol supplements are required for (21 CFR 812.35):

New protocol Changes to existing protocol (amendments) New investigator New study site Changes to investigational device

Original IDE application

FDA letter of approval

IDE supplements

Investigator agreements

Other correspondence with FDA (e.g. response to a clinical hold, general correspondence)

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed ☐ NA

Record of having read the regulations IDE Responsibilities:https://www.fda.gov/medical-devices/device-advice-investigational-device-exemption-ide/ide-responsibilities

☐ NA

☐ NA

☐ NA

☐ NA

☐ To be completed when applicable




☐ Completed

Date: ______

☐ NA



Report Date

Complete if you are a Sponsor. SPONSOR RESPONSIBILITIES – Significant Risk IDE Regulations Corresponding Onsite Documents Response

IDE safety reports (21 CFR 812.46(b)), 812.50(b)) Serious, related, unexpected or significant preclinical findings (written reports, e.g. MedWatch 3500A to FDA, and all participating investigators if applicable within 10 calendar days)

Follow-up information to a safety report (submitted as soon as available)

IDE safety reports Evidence of correspondence to other investigators

☐ Completed

☐ NA

☐ NA

Annual reports (21 CFR 812.150(b)) Before or on the anniversary date that the IDE went into effect

Annual report

Current investigator list Provide FDA, at 6-month intervals, a current list of names and addresses of all investigators participating in the study (21 CFR 812.150(b)(4))

Investigator list (every 6 months)

INFORMING INVESTIGATORS (21 CFR 812.45)

Provide all clinical investigators with instructions for use or clinician’s manual.

Inform investigators of new observations discovered by or reported to the sponsor on the investigational product.

Instructions for use or clinician’s manual

For multi-site studies:

Documentation that all sites have received the instructions or clinician’s manual

Documentation of communication with investigators regarding new observations and adverse events

☐ Completed

☐ Completed


☐ NA

☐ Completed

☐ Completed

☐ NA

☐ NA








Report Date

Regulations Corresponding Onsite Documents Response

SELECT QUALIFIED INVESTIGATORS AND MONITORS (21 CFR 812.43; 812.140(b)(3))

Select PIs qualified by training and experience

Signed Investigator Agreement

Current Investigator CV and license

IRB approval

For Multi-site studies (applies to training and shipping investigational product):

Investigator information is required for each site

PI CV is provided to FDA

Financial disclosure from such as FDA form 3455 for PI and Co-Investigators listed on 1572/Investigator Agreement

For Monitoring of Study University of MN Monitoring Services Other (specify):

Ship investigational product only to those investigators participating in the trial

Keep accurate records of financial disclosure according to 21 CFR 54

Select monitors qualified by training and experience

Complete if you are a Sponsor. SPONSOR RESPONSIBILITIES – Significant Risk IDE

CV and training experience of monitor

Ensure monitor is trained on protocol

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed


☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA











Report Date

Complete if you are a Sponsor. SPONSOR RESPONSIBILITIES – Significant Risk IDE Regulations Corresponding Onsite Documents Response ENSURE ONGOING MONITORING (21 CFR 812.46)

Ensure proper monitoring Documentation of safety monitoring plan

Who will be reviewing safety data: Sponsor (or Sponsor-Investigator)

DSMB

Medical monitor

Other (specify):

Reports/meeting minutes from DSMB and/or medical monitor

Documentation of data monitoring plan

Research team has been trained on data collection sheets and/or CRFs

Correspondence with monitor

Documentation of monitoring

Timely notifications to all investigators, IRB and FDA if investigation discontinued.

Ensure PI compliance or discontinue shipments of investigational device

Review and evaluate device safety and effectiveness

Discontinue investigation within 5 working days when unreasonable and significant risks to subject are identified.

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed


☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA












Report Date

Complete if you are a Sponsor-Investigator. INVESTIGATOR RESPONSIBILITIES – Significant Risk IDE (SR IDE) Regulations Corresponding Onsite Documents Response Assure IRB review and approval and prompt reporting according to IRB guidelines (21 CFR 812.110, 812.150(a))

Initial IRB approval

Scheduled continuing review

Amendments describing any study changes

Adverse event reports according to IRBMED guidance or study specific plan

Unanticipated problems

Protocol deviations reported to the IRB

Instructions for use or clinician’s manual

Other IRB correspondence Maintain adequate and accurate case histories on each subject’s participation in the trial (21 CFR 812.140(a)(3))

Signed and dated consent forms for all subjects

Supporting data (source documents)

Case report forms (CRFs)

Subject eligibility documentation

Progress notes

Concomitant medications recorded

Obtain informed consent in accordance with provisions in 21 CFR50

Approved consent form document that includes all required elements

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed









☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA









Report Date

Complete if you are a Sponsor-Investigator. INVESTIGATOR RESPONSIBILITIES – SR IDE Regulations Corresponding Onsite Documents Response Supervise the conduct of the clinical investigation (21 CFR 812.100) ensuring:

Appropriate delegation of tasks Adequate training to protocol Adequate supervision

Delegation log

Staff training log

Minutes from research team meetings to review trial progress, AEs, protocol changes

Notes from meetings with study monitor

Written procedures for internal review of data

Protect the rights, safety and welfare of study subjects (21 CFR 812.100)

Adhere to protocol

Provide reasonable medical care for AEs

Inform subject when medical care is needed for conditions unrelated to research

Investigator is available to subjects during conduct of study

Appropriate delegation to co-investigators if PI is not available

Investigator is responsible for providing sponsor with reports (21 CFR 812.150(a))

Progress reports Safety reports Deviations from investigational plan Final reports Financial disclosure reports

Investigator has provided sponsor with pertinent correspondence (enrollment numbers, adverse events, financial information, and any changes in financial information).

N/A, Single center study

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA














Report Date

Complete if you are a Sponsor. DEVICE ACCOUNTABILITY – SR IDE Regulations Corresponding Onsite Documents Response

Sponsor is responsible for record of device disposition (21 CFR 812.43(b), 812.140(b)(2))

Receipt: Device received from industry. Device accountability log includes:

Receipt date

Quantity

Lot #

Return/disposition

Method of disposal

Device manufactured on-site

Shipment: Single center study – no device shipment Device shipped to multiple sites. Device accountability log includes:

Date

Destination

Who shipped

Quantity

Lot #

Return/disposition

Maintain adequate record of receipt and shipment of investigational device

Assure return of all unused investigational devices from individual investigators participating in the trial or authorize alternative disposition of unused product.

Maintain written records of any disposition of devices.

Method of disposal

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA
















Report Date

Complete if you are a Sponsor-Investigator. DEVICE ACCOUNTABILITY – SR IDE Regulations Corresponding Onsite Documents Response Investigator is required to maintain adequate records of the disposition of the device (21 CFR 812.140(a)(2))

Device dispensing record includes: Date

Lot #

Quantity

ID of subject administered

Disposition/record of return

ID of person dispensing

Return of device: Count

Reason

Investigator is responsible to ensure control of investigational device (21 CFR 812.110(c))

Device will be administered only to those subjects enrolled in the clinical study and under investigator or designee’s supervision.

Enrollment / randomization log

Delegation of responsibility log

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA











Report Date


RECORD RETENTION – SR IDE


Sponsor and Investigator requirement for inspection of investigator’s records and reports:

Upon request, permit University, FDA officer and/or other governmental officials to access copy and verify any records or reports made by the investigator to ensure that the study is conducted in a safe and proper manner.

When contacted by the FDA to schedule an inspection (or the FDA has arrived without advance notice), the PI or a member of the research team is expected to immediately contact the following offices: HRPP and IRB of Record.

Records on file

Complete if you are a Sponsor or a Sponsor-Investigator. IDE Regulatory Inspections

☐ Completed ☐ NA ☐ To be completed when applicable


Purpose: This form is for researchers to use to conduct a self-assessment of their IRB approved Non-Significant Risk (NSR) IDE Device study. NSR IDE Device studies fall into the category of an abbreviated Investigational Device Exemption (IDE) set forth in CFR 812.2 (b). The purpose of this self-assessment is to help researchers assess whether they’re meeting their regulatory obligations and institutional guidance. The form is in two parts. Part One is intended to be completed at the time of study initiation, after initial IRB approval and receipt of the device. Part Two should be completed at the time of the first scheduled continuing review.

If you have any questions or concerns regarding compliance with NSR IDE device regulations, contact [email protected]

PART ONE

Device Labeling

1a. FDA requires device labels (or container labels for devices that cannot be labeled) to state: “CAUTION - Investigational Device, limited by Federal law to investigational use”. Is the device labeled as such? (§812.5)

☐ YES ☐ NO ☐ N/A

1b. FDA requires labels to include the name of the manufacturer. (§812.5) Does the label meet this requirement?

1c. FDA states labels cannot contain any statement that the device is safe or effective for the purpose it is being investigated. (§812.5) Does the label meet this requirement?

☐ NO ☐ N/A☐ YES

Monitoring

2a. FDA requires monitoring of non-significant risk device studies to ensure ongoing subject safety, data integrity, and compliance with the protocol. Do you have such a monitoring plan? (§812.43, §812.46)

☐ NO ☐ If NO, please explain☐ YES

Report Date

☐ YES ☐ NO ☐ N/A

Complete if you are a Sponsor of an NSR IDE (Abbreviated IDE)

Report Date


Verification subject signed and dated currently approved consent form

Adherence to inclusion/exclusion criteria

2b. If Yes, which of the following FDA recommended components have you included as part of the plan?

Training

3. Have all co-investigators and key study personnel been trained to the protocol and delegated tasks?

☐ NO

☐ If NO, please explain

Note: It is recommended that training logs or study team meeting minutes be on file to meet this requirement.

Case Report Forms/Study Documentation

4. Have you created study documentation, such as case report forms (CRFs), that accurately reflect the approvedstudy and have a place for the signature and date of the person(s) obtaining the information?

☐ YES

Records and Storage

☐ NO ☐ If NO, please explain

5. In general, it is recommended to maintain records of the shipping and receipt of each device (quantity, date

of receipt, name of person receiving). Are these records being maintained?

☐ YES ☐ NO ☐ If NO, please explain

6. In general, it is recommended to provide secure storage for all devices in order to maintain propercontrol of the device(s). Is the device(s) stored in a secure location?

☐ NO ☐ If NO, please explain☐ YES

Additional Resources

FDA Webpage IDE Responsibilities https://www.fda.gov/medical-devices/device-advice-investigational-device-exemption-ide/ide-responsibilities

For questions related to this checklist contact HRPP at ([email protected]) or call IRB (612) 626-5654


☐ YES ☐ NO

☐ If NO, please explain☐ YES

Verification that protocol is being followed

Review of accuracy and completeness of data

Other:

Review of documentation, management and reporting of adverse events to the IRB

☐ If NO, please explain☐ YES ☐ NO





☐

☐

☐

☐

☐

☐

PART TWO

Monitoring (please note that documentation of monitoring is required and should be uploaded with your SCR) 1. Are there completed monitoring reports or other documentation that the monitoring plan is being followed?

☐ YES ☐ NO ☐ If NO, please explain

Records and Storage

2. In general, it is recommended to maintain complete records of the disposition of each device (quantity, date of disposal/ return, name of person

disposing of the device). Are these records being maintained?☐ YES ☐ NO ☐ If NO please explain

Adverse Events and Recalls

3a. Were there any unexpected, serious adverse events related/possibly related to the study device? (§812.150(b)(1)) ☐ YES ☐ NO

3b. If Yes, were they submitted to both the FDA and IRB within 10 business days of notification of the event?

☐ YES ☐ NO

(For questions on how to submit adverse events to the FDA, contact the Division of Industry and Consumer Education (DICE) within FDA Medical Devices at contact DICE at FDA).

For questions related to this checklist contact [email protected]

University of Minnesota Registration Checklist and Self-Assessment

IDE Sponsor or Sponsor-Investigator

Report Date

Report Date


IDE Sponsor or Sponsor-Investigator University of Minnesota Registration Checklist and Self-Assessment

Current Good Manufacturing Practice will be applied according to the FDA guidance.

Significant Risk (SR) and NonSignificant Risk (NSR) IDEs -Complete if you perform Device Manufacturing at a UMN facility

Sponsor is responsible for device manufacturing controls

Design Control Guidance For Medical Device Manufacturers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers


Significant Risk (SR) and Non-Significant Risk (NSR) IDEs - Complete if this is a Multi-Site ResearchRegulations Corresponding Onsite Documents Response

A multi-site study is defined as a study in which the UMN investigator is conducting research at a site(s) not affiliated with the Organization. Examples include public elementary schools, nursing homes, independent health care facilities, private practices, etc. The following information must be provided in the IRB application for studies for which the UMN IRB will serve as the IRB of record for conduct at one or more non-UMN sites:

Confirmation that the Coordinating Center PI has contact information for all centers;

A plan for review of each center’s IRB approval documents and consent forms;

Confirmation that each participating center has on file an FWA with OHRP (if the research is federally funded)

A method for assuring that all centers have the most current version of the protocol and that amendments to the protocol will be communicated to all centers

A plan for collection and management of data from all centers

A process for reporting and evaluating protocol events anddeviations from participating centers.

Report Date

☐ Understood ☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed







Sponsor is responsible for complying with Prohibition of promotion and other practices

Prohibition of promotion and other practices: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=812.7 Application and Administrative Action:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=812.20

☐ NA☐ Understood

University of Minnesota Registration Checklist and Self-Assessment

Comments

Significant Risk (SR) and Non-Significant Risk (NSR) IDEs - Complete if this is a Multi-Site ResearchRegulations Corresponding Onsite Documents Response

A multi-site study is defined as a study in which the UMN investigator is conducting research at a site(s) not affiliated with the Organization. Examples include public elementary schools, nursing homes, independent health care facilities, private practices, etc. The following information must be provided in the IRB application for studies for which the UMN IRB will serve as the IRB of record for conduct at one or more non-UMN sites:

Name and address of the site

Name of the contact at the site

Contact information (phone and email)

Whether the site provided permission to conduct the research at that site

Whether the site has an IRB

Whether the site’s IRB has approved the research

Whether the site is an international site, and if so, whether it has an FWA (for federally funded studies)

E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1

Report Date

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ NA

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed

☐ Completed









IDE Sponsor or Sponsor-Investigator

University of Minnesota IDE Sponsor or Sponsor-Investigator · University of Minnesota IDE Sponsor...

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