Quality Improvement Visits

Routine Quality Improvement Visits

What is the purpose of routine QI Visits?
How are studies selected for Routine QI Visits?
What happens during a Routine QI Visit?
What documentation is reviewed during a Routine QI Visit?
What does the “regulatory binder” include?
What are some common findings?
What happens after the Routine QI Visit?
Who has access to the QI Routine Visit Report?
What follow-up actions may be required by the REB?

 

Directed Quality Improvement Visits

What is the purpose of a Directed QI Visit?
Who authorizes a Directed QI Visit?
Who conducts the Directed QI Visit?
What to expect during a Directed QI Visit?
What happens after the Directed QI Visit?

 


Routine Quality Improvement Visits

What is the purpose of routine QI Visits?

They serve to ensure that the study is conducted as it was approved by the REB. They assess compliance with

  • The study protocol
  • Study-specific REB requirements
  • MUHC Regulatory Framework
  • McGill Institutional policies where applicable
  • Pertinent laws, regulations and guidelines for the protection of human research participants. Examples include:
    • The Tri-Council Policy Statement
    • The FRSQ Guide d’éthique de la recherché et d’intégrité scientifique
    • The U.S. “Common Rule” (Code of Federal Regulations Title 45 Part 46)
    • The Declaration of Helsinki

They are intended to be educational in nature because they can:

  • Provide positive feedback
  • Identify solutions where there is room for improvement
  • Present excellent opportunities to ask questions related to research ethics.
  • Offer support to all members of the research team

Routine QI Visits may focus on issues such as:

  • The ethics review process
  • Identification and recruitment of participants
  • The informed consent process
  • Participant eligibility
  • Protocol adherence
  • Safety reporting
  • Privacy and confidentiality
  • Ethical issues relating to a particular area of research, e.g. vulnerable populations, research involving tissues, human gametes and embryos

How are studies selected for Routine QI Visits?

  • On a not-for-cause basis. Study misconduct is not suspected.
  • Performed by a qualified MUHC statistician who is otherwise unaffiliated with the REO.
  • Randomly selected from the REBs’ databases on a monthly basis. These studies include:
    • Studies approved by the nine MUHC REBs and the McGill University Faculty of Medicine IRB. The number of visits per REB is proportional to the volume of research they review.
      • When studies reviewed by the McGill University Faculty of Medicine IRB are selected, the QI Visit will focus on study activities conducted at the MUHC.
    • If a principal investigator’s study is selected for a Routine QI Visit, the investigator’s other studies will not be selected for at least one year.

What happens during a Routine QI Visit?
On the day(s) of the visit, the QA coordinator will

  • Meet with the principal investigator and/or research team members actively involved in the study
  • Review the study documentation.
  • View the study facilities, where appropriate.
  • Discuss any ethical or regulatory issues with the study team.
  • Provide guidance on best practices in research ethics.

What documentation is reviewed during a Routine QI Visit?
Studies at the MUHC span a wide range of therapeutic areas, methodologies and patient populations. Each study is organized differently and different regulatory requirements may apply, so the documentation reviewed varies accordingly. The following documentation may be reviewed:

  • The regulatory binder
  • Signed informed consent forms
  • Logs sheets documenting that participants have met the inclusion criteria
  • Participants’ medical records (if they are MUHC patients)
  • Participants’ research records (or other documents where raw data is recorded, if applicable)
  • Completed questionnaires or other data provided by participants.
  • Case report forms (for clinical trials and occasionally other studies)
  • Electronic databases in which research data is stored.

What does the “regulatory binder” include?
Study teams involved in clinical trials will be familiar with the concept of a “regulatory binder” or “regulatory file.” It contains REB, Sponsor and Regulatory Authority correspondence and other important documents (e.g. safety reports). QI Visits will particularly focus on correspondence with the REB and documents submitted to it, as this stands as the record for the ethics review process.

All study teams are required to maintain the following documentation in a well-organized fashion:

  • All documents submitted to the REB, including:
    • The study protocol and any amendments
      • Accompanying documentation such as questionnaires, advertisements etc.
    • All versions of the consent form
    • Applications for initial review and continuing review
    • “Revision to an approved study” (Amendments)
    • Reports for
      • Change of study status
      • Adverse events
      • Protocol deviations
      • Study termination
    • Any applicable annexes and other forms.
  • All correspondence with the REB
    • Letters requesting clarifications of or changes to the study
    • Letters providing initial approval and continuing approval

What are some common findings?
Common findings may include:

  • Positive findings- (Ethically appropriate aspects of the study are highlighted)
  • Minor administrative violations. For example, ethical breaches regarding the:
    • Consent process
      • Dates are missing from Consent Forms
      • Consent forms are signed by non-designated person
    • Correspondence with the REB
      • Documents missing
      • Failure to notify the REB when the study is terminated

      Please note that if investigators are formally audited, minor protocol violations become substantive issues.

Less common findings include:

  • Serious administrative or human subject protection protocol violations. For example:
    • Study tasks are delegated to unqualified individuals
    • Research procedures are initiated before informed consent is obtained.

What happens after the Routine QI Visit?

  • The principal investigator and the REB will receive a QI Report [.pdf] (a hard copy and an electronic version) containing the findings, applicable regulations and recommendations resulting from the visit.
    • The findings are usually known to the study team as they were raised during the on-site visit.
  • The principal investigator is invited to submit comments to the REB regarding the report
    • These comments, if any, are to be added to the electronic version and submitted to the REB of Record and the Quality Assurance Coordinator. The deadline for submission for the next REB meeting is included in the cover letter sent to the investigator.
  • The study team will be invited to complete a brief questionnaire [.pdf] about the QI Visit. The information gathered helps to improve the QA program on an ongoing basis and to ensure that it is meeting its educational objectives.
  • The REB will review the report including the investigator’s comments, if any, at its next meeting. The REB may:
    • Endorse the QA coordinator’s recommendations. Please note that the REB must endorse the recommendations before they become binding.
    • Propose different solutions to the issues identified.

Who has access to the Random QI Routine Visit Report?

  • QI Routine Visit reports are not to be shared with research sponsors and/or any of their representatives. MUHC policy requires that investigators keep QI Visit Reports confidential and separate from the study documentation and records. **
  • QI Routine Visits are educational in nature and therefore, the report should be shown to members of the study team.
  • The investigator may also wish to discuss the findings and recommendations with MUHC colleagues who are conducting similar studies

What follow-up actions may be required by the REB?

The REB may require that:

  • No further action be taken
  • The study team attend educational sessions on applicable topics
  • The QA coordinator conduct a follow up site visit to ensure that research activities are conducted in compliance with REB requirements
  • The QA staff examine specific issues in greater depth

Routine Chart

 

Directed Quality Improvement Visits

 

What is the purpose of a Directed QI Visit?

  • To verify a justifiable allegation, a reasonable suspicion of misconduct or serious deficiency in the ethical conduct of a study
    • They are conducted on a “for-cause” basis

Who authorizes a Directed QI Visit?

  • Two officials or agencies responsible for research oversight, such as:
    • The chair of the REB of Record
    • The REB of Record by resolution of the full board
    • The Director of the Research Ethics Office
    • The Associate Director of Clinical Research of the RI-MUHC
    • The Scientific Director of the RI-MUHC
    • The Director of Professional Services of the MUHC
    • The Director of the Montreal Neurological Institute (for MNI-related studies or staff)
    • An Ombudsman of the MUHC
    • A Medical Examiner of the MUHC
    • The Dean of the Faculty of Medicine of McGill University (for studies involving Faculty of Medicine staff)
    • The CEO of the MUHC
    • The Board of Directors of the RI-MUHC
    • The Board of Directors of the MUHC

Who conducts the Directed QI Visit?

  • The Quality Assurance and Education Officer has the responsibility to conduct Directed QI Visits
  • Depending on the specific nature of the allegation or suspicion of misconduct or the area or type of study, a professional with relevant expertise may be consulted and/or the QA coordinator may provide assistance

What to expect during a Directed QI Visit?

  • This process consists of
    • A meeting with the principal investigator as well as other members of the study team, as required
    • A review of the regulatory binder (see above), the correspondence file and other pertinent documents at the research site.

What happens after the Directed QI Visit?

  • The Final report, which includes the findings, applicable regulations and recommendations, will be submitted to the REB committee. Please note that this committee must endorse any recommendations before they become binding.
  • The principal investigator will receive the report (hard copy and electronic) without the recommendations. He or she is invited to comment on them prior to the REB review.
    • These comments, if any, are to be added to the electronic version and submitted to the REB of Record and the linda [dot] furlini [at] muhc [dot] mcgill [dot] ca (Quality Assurance and Education Officer). The deadline for submission for the next REB meeting is included in the cover letter sent to the investigator.
  • The REB will review the report including the investigator’s comments, if any, at its next meeting. The REB may
    • Endorse the Quality Assurance and Education Officer’s recommendations.
    • Propose different solutions to the issues identified
    • May require that the Quality Assurance and Education Officer follow up with the Investigator and study team members to ensure that research activities are conducted in compliance with REB requirements

Directed Chart [.pdf]

**Where serious violations of ethical guidelines or regulations have been discovered either during a Routine of Directed QI Visit, they will be reported to the REB of record. The REB will review and assess the QI Visit findings and determine appropriate action. The REB and the MUHC are obliged by law to report serious cases of ethical or scientific misconduct to the appropriate authorities. Click to view the MUHC Regulatory Framework [.pdf].

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