Audit and Analysis

Quality Management in Clinical Research

The Quality Management in Clinical Research (QMCR) Department was created as an oversight mechanism for human research activities conducted at the University of Alberta.

 

In order to ensure QMCR has an arms’ length relationship with both ethics and research administration, it was decided, with the approval of the Board Audit Committee, that the unit be housed with Internal Audit Services.

 

While the endorsed mandate is broad, QMCR will initially direct its services towards clinical trials where the University of Alberta is considered the sponsor organization (i.e. Principal Investigator-Initiated trials). This initial focus is based on elements of risk associated with specific trials as well as resource constraints.

 

Mission

 

The mission of the Quality Management in Clinical Research unit is to ensure clinical research at the University of Alberta is conducted according to the highest scientific and ethical standards, complies with local, national, and international policies as well as governing statutes and regulations, and that internal quality systems are comprehensive, appropriate, and effective.

 

Values

 

Society places a trust in scholars and researchers to pursue knowledge in a manner that respects the values of beneficence, freedom from exploitation, honesty, fairness and justice.  These values will be characterized by a dedication to excellence demonstrated through:

 

Integrity

QMCR will work to establish trust and thus provide a basis for reliance upon its judgment.

 

Objectivity

QMCR will exhibit the highest level of professional objectivity in gathering,evaluating and communicating information about the activity or process being examined.

 

Confidentiality

QMCR will respect the value and ownership of information received and not disclose information  without appropriate authority unless there is a legal or professional obligation to do so.

 

Competency

QMCR will apply the knowledge, skills and experience needed in the performance of its quality management services.

 

Mandate

 

QMCR’s mandate is to take an integrated approach to assuring that the rights, safety and well-being of trial subjects are protected and that clinical data generated at the University of Alberta are credible.

 

The QMCR Department was created as an oversight mechanism for human research activities conducted at the University of Alberta.

 

In order to ensure QMCR has an arms’ length relationship with both ethics and research administration, it was decided, with the approval of the Board Audit Committee, that the unit be housed with Internal Audit Services.

 

While the endorsed mandate is broad, QMCR will initially direct its services towards clinical trials where the University of Alberta is considered the sponsor organization (i.e. Principal Investigator-Initiated trials). This initial focus is based on elements of risk associated with specific trials as well as resource constraints.

The QMCR Department was created as an oversight mechanism for human research activities conducted at the University of Alberta.

 

In order to ensure QMCR has an arms’ length relationship with both ethics and research administration, it was decided, with the approval of the Board Audit Committee, that the unit be housed with Internal Audit Services.

 

While the endorsed mandate is broad, QMCR will initially direct its services towards clinical trials where the University of Alberta is considered the sponsor organization (i.e. Principal Investigator-Initiated trials). This initial focus is based on elements of risk associated with specific trials as well as resource constraints.

The QMCR Department was created as an oversight mechanism for human research activities conducted at the University of Alberta.

 

In order to ensure QMCR has an arms’ length relationship with both ethics and research administration, it was decided, with the approval of the Board Audit Committee, that the unit be housed with Internal Audit Services.

 

While the endorsed mandate is broad, QMCR will initially direct its services towards clinical trials where the University of Alberta is considered the sponsor organization (i.e. Principal Investigator-Initiated trials). This initial focus is based on elements of risk associated with specific trials as well as resource constraints.