Research Compliance

What training do I need?

What training do I need?

What training do I need and how do I get it? (eg HIPPA, CITI, Biohazards)                   

Good Clinical Practice (GCP) Training---Collaborative Institutional Training Initiative (CITI)

As of January 1, 2017, NIH expects investigators involved in NIH-supported clinical trials, and staff who design, oversee, manage or conduct clinical trials, to receive training in GCP. UMN accepts the CITI course on GCP training (the same host used for the UMN’s coursework on the Use of Human Subjects in Research). The CITI course is designed specifically for clinical researchers to have an understanding and knowledge of the federal regulations, International Council for Harmonisation (ICH) regulations, and Good Clinical Practice guidelines that apply to clinical research. All coursework completed using the UMN login procedures below will be automatically added to your UMN PeopleSoft training record. Questions can be directed to the IRB.  To complete the CITI course:

  • Go to https://www.citiprogram.org
  • In the box labeled “Log in through my institution”, clinic on “Log in via SSO”, and choose University of Minnesota from the resulting list.
  • From the menu of options, choose “Add a Course”.
  • The GCP course is listed under Question #3, check the GCP checkbox in that section.
  • Scroll to the bottom and click on “Submit”.

 

Health Insurance Portability & Accountability (HIPPA) training can be found at http://www.healthprivacy.umn.edu/training

 

The Biosafety Program offered through the Department of Environmental Health and Safety provides biohazard training. Their website is http://www.dehs.umn.edu/bio.htm.

How do I hire a coordinator?

How do I hire a coordinator?

It is highly recommended that research coordinator support is hired through the Department’s Clinical Research Services program. http://www.pediatrics.umn.edu/research/clinical-research-services . Contact Amanda Galster, gals0004@umn.edu, 612-625-4443.  She can help you identify the appropriate classification and salary, and can assist with on-boarding training.

Who can help me with IRB applications and what is ETHOS?

Who can help me with IRB applications and what is ETHOS?

The Department’s Clinical Research Services program. http://www.pediatrics.umn.edu/research/clinical-research-services.  Contact Amanda Galster, gals0004@umn.edu, 612-625-4443.

Ethical Oversight Submission System (ETHOS) is the new web-based platform for IRB submissions being launched spring 2017.  This program will streamline the application process and will replace the current applications and appendices. New protocol templates are also being released.

What are the rules for animals in research?

What are the rules for animals in research?

These can be found at http://www.research.umn.edu/iacuc/ .

What is OnCore and how do I use it for clinical research?

What is OnCore and how do I use it for clinical research?

OnCore, https://oncore.umn.edu/,  is now UMN’s official Clinical Trials Management System.  It has replaced TASCS, and offers additional new functionality.  It was purchased in 2013 with funds from the CTSA, and was rolled out across the AHC during 2014-2016.  Pediatrics began registering new studies in February 2015.  Study registration and routine updates are required for all human-subjects research. See the minimal requirements at http://www.ctsi.umn.edu/researcher-resources/clinical-trial-management-system/studies-enter-oncore.  Studies utilizing Fairview and/or UMP services must use the Calendar feature, and individual subjects and visits must be entered. OnCore does have electronic data capture capabilities, and for some studies may be preferable to REDCap. View a comparison of OnCore and REDCap at: https://docs.google.com/document/d/1J64695A3hT4xB_bD4JcmoVnhJkwxkQabddyXFyPYoRE/edit.

 

Currently there are some integrations between OnCore and the CTSI Portal and with Epic. An initial link to documents is being planned with the IRB’s new ETHOS system. Additional integrations are being planned that will help reduce coordinator burden and duplicative entry.

What is REDCap?

What is REDCap?

REDCap (Research Electronic Data Capture) is a secure, HIPAA compliant  web application designed to support data capture for research.  It allows users to build and manage online surveys and databases.  One of its biggest advantages is that it has been promoted by the NIH across all NIH-sponsored clinical centers, and thus it is ideal for multiple-site studies.  You can log into REDCap with your UMN X.500 account at https://redcap.ahc.umn.edu/ for help getting started and a variety of training tools. The UMN REDCap help page is found at https://sites.google.com/a/umn.edu/redcap-help/. View a comparison of OnCore and REDCap at: https://docs.google.com/document/d/1J64695A3hT4xB_bD4JcmoVnhJkwxkQabddyXFyPYoRE/edit.

 

What is Quartzy and how do I use it to order laboratory items?

What is Quartzy and how do I use it to order laboratory items?

Quartzy is a free online lab management platform that can be used to manage a lab’s inventory and track order requests.  It is found at https://www.quartzy.com/ .

What is the process for ordering equipment (bidding justifications)?

What is the process for ordering equipment (bidding justifications)?

Equipment that is $10,000 or more must go through a justification procedure that may include a competitive bidding process. Purchasing procedures are described here http://purchasing.umn.edu/purchasing-methods-procedures.html and at http://policy.umn.edu/finance/purchasing-appa.

What do I need to know about patent applications?

What do I need to know about patent applications?

The Office of Technology Commercialization (OTC) works with faculty on every piece of new intellectual property created at the University of Minnesota. The OTC should be contacted through http://www.research.umn.edu/techcomm/inventor-contact.html if the following has occurred:

  • Your research has resulted in a new discovery
  • You plan to publish or present your discovery
  • Your research has federal funding or is industry sponsored and may have resulted in intellectual property
  • You want to send research tools or materials to another institution
  • A company has contacted you and wants to learn more about your research
  • You want to start a company based on your technology

The OTC is available to explain the details of a technology disclosure within UMN. All inventions need to be disclosed to the University through OTC at http://www.research.umn.edu/techcomm/report.html. Once this form is filled out, OTC will help the inventor through the next stages of investigating and protecting the invention, including patent protection.

 

Before an invention has been disclosed to the University and discussed with OTC, it should be considered confidential and should not be shared through publications or presentations without a non-disclosure agreement (NDA). More information about the disclosure and patent process at UMN is at http://www.research.umn.edu/techcomm/inventor-faqs.html.  If the technology is a pediatric health technology or medical device, The Pediatric Device Innovation Consortium (www.thepdic.org) is happy to assist the inventor in understanding the next steps towards commercialization. Grants are also available to inventors working on pediatric medical devices through the PDIC.

How do I schedule a conference call?

How do I schedule a conference call?

Conference Call From Any University Phone Including Your Office

For any conference call requiring people from three or more locations to be involved in the call, a digital conferencing bridge is required. Please work with your administrative support to set up a West Communications (formerly Intercall) account. This can be set up through OIT at https://it.umn.edu/reservationless-plus-conferencing-sign.

  • To use your West Communications account:

­   Dial phone number provided by West Communications

­   Enter account number, then press #

­   Press * when prompted to identify yourself as the leader

­   Then enter your leader PIN followed by #

­   This leader PIN should not be shared

­   Press 1 to start your conference call

  • To Join a West Communications account call:

­   Dial phone number provided

­   When prompted, enter provided account number followed by #

 

Wilf Family Center Conference Room Conference Call

To schedule a conference call in one of the Wilf conference rooms:

­   If you have an account, select Log In option under the “My Account” tab, and log in using your username and password

­   If you do not have an account, select Create an Account option under the “My Account” tab           

  • Once logged in, select Request a Space option under the “Reservations” tab

­   You will need to Date, Time, Attendance, and Set Up Type (conference room or auditorium)

­   Then click on the “Find Space” icon

­   The system will display all available rooms. Any space left white, is available for that room on that day

­   Click on the green and white icon  to request a space

­   Review and agree to the terms and conditions and then select continue

­   You will then need to provide contact information and details regarding the meeting

­   Indicate on this page any A/V needs you have for your meeting

­   Note that this is only a request for the space, you will receive a confirmation email upon completion

  • Note that reservations need to be made 10 business days in advance

 

If you are the host and have scheduled a Wilf conference room:

  • An A/V technician will be in the room at the start of your meeting to assist with any technical needs
  • An up-to-date guidebook is available in each room to assist with any issues
  • The preferred conferencing system is Acano. It is free and set up by the Fairview A/V technician.
  • There are no traditional phone systems in the rooms, microphones are placed throughout room and dialing is performed via keypad.

 

Acano audio/video conferencing instructions:

  • A/V technician will provide the reservation contact with login and passcode instructions.
  • A/V technician will set up call from room
  • Guests calling in:

­   Using google chrome, log into https://join.fairview.org (or use provided meeting-specific URL)

­   Enter passcode at prompt

  • If you have any connection issues, call Acano at 855-465-3409

What is the difference between monitoring and an audit? What do I do if I am audited?

Monitoring

Monitoring

Monitoring is the act of overseeing the progress of a trial, and ensuring that it is being conducted in accordance with the protocol, applicable SOPs, and regulations and policies. The purpose is to:

  • Ensure the rights and well-being of human subjects are protected
  • Ensure the reported trial data are accurate, complete, and verifiable from source documents
  • Ensure compliance with the protocol, regulations, etc.

Monitors are appointed by the sponsor, should be appropriately trained, and have the needed knowledge to monitor the trial adequately.  Monitoring is a continuous quality control process throughout the lifespan of the study. Monitoring may happen in person on-site, or may be conducted remotely on-line.

 

Responsibilities of a study monitor typically include:

  • Verifying investigator’s qualifications, expertise, resources, and availability throughout the study
  • Ensure adequate availability, storage, dispensing, and return of investigational products
  • Ensure appropriate distribution of investigational product to eligible subjects, as specified in the protocol
  • Ensure protocol compliance and maintenance of essential documents by the investigator and delegated staff
  • Verify study tasks are not delegated inappropriately
  • Informing sponsor of deviations and violations
  • Provide written reports to the investigator and the sponsor

 

Investigator responsibilities for study monitoring:

  • Ensure sufficient accommodations  for the monitor to work
  • Provide sufficient information to the monitor
  • Be available to meet in person to discuss findings
  • Be responsive and proactive
  • Submit written reports to UMN IRB

Auditing

Auditing

Auditing is an independent examination of study related activities and documents. The purpose is to evaluate study conduct and compliance with the protocol, SOPs, regulations, etc.  Audits may be part of a routine quality assurance plan, or may be a for-cause investigation of suspected noncompliance. Auditors are independent of the study sponsor or research team. Auditors may be internal or external to the researcher’s institution. 

  • Examples of UMN internal audits: routine IRB Post-Approval Reviews (PAR), for-cause investigations, etc.
  • Examples of external audits include: routine or for-cause audits by funding sources, FDA inspections of high-enrolling sites, FDA for-cause investigations, OHRP investigations, etc.

Investigator responsibilities during an audit:

  • Ensure sufficient accommodations to review study documents and meet with study team
  • Be present and responsive, attend opening and closing meetings
  • Encourage all study team members, including sub-investigators, to attend closing meeting

Investigator responsibilities after an audit:

  • Receive the audit report
  • Submit the audit report to the IRB
  • Prepare formal response (which may need to include a corrective action plan)
  • Develop prevention/corrective action plan (as needed)

If you are notified of an FDA (or other federal) audit:

  • Politely work with the auditor to schedule a reasonable date and time
  • Notify your Division Head, the Department Head, and the Associate Head for Research
  • Notify the IRB at 612-626-5654 or irb@umn.edu
  • Notify the study sponsor
  • If the study involves an investigational drug or device, notify the IND/IDE Director at medreg@umn.edu
  • Make sure your study files are in order – get help if needed.
  • Assign a staff member to accompany the auditor at all times.
  • Assign a scribe to document all conversations and documents shared.

Most Common Deficiencies:

  • Failure to follow the investigational plan/protocol
  • Protocol deviations
  • Inadequate case histories, failure to retain records

­   discrepancies between source records and study data

­   lack of supporting raw data

  • Inadequate accountability of the investigational product
  • Inadequate subject protection

­   informed consent issues

­   failure to report adverse events

Most Significant Clinical Investigator Violations (Significant because place subjects at risk, violates regulations, and may result in warning letters or disqualification):

  • Enrolling ineligible subjects
  • Enrollment exceeding protocol or IRB limit
  • Failure to conduct required evaluations/safety assessments
  • Violation of a Clinical Hold (for example, some protocols have built in clinical holds after a certain number of subjects are enrolled to review safety data before proceeding, or sometimes studies are placed on hold if safety issues arise---no new patients may be enrolled until the hold is released)
  • Submission of false information to sponsor
  • Use of drug/device before submission of IND/IDE