Services Provided

Clinical Trial Application (CTA) Administration

All PI-initiated trials requiring a clinical trial application to Health Canada must seek the assistance of QMCR's Clinical Trial Application administrator. The administrator will guide you through the CTA process and review your application prior to obtaining Dean, Chair and Senior Executive Officer signatures

Risk Assessment

QMCR will send all PI-initiated trial protocols requiring a clinical trial application to Health Canada for review by the PI as well as independent reviewers. The resultant score will serve as the basis for determining the degree of trial monitoring that will be provided, risk based audit selection as well as data safety monitoring requirements. QMCR will provide guidance for data safety monitoring plans and board set up (DSMP/DSMB) for high risk trials. Management

QMCR provides support for all PI-initiated trails. The administrator will set up accounts for investigators under University of Alberta sponsorship. Investigators will be able to register trials and enter all required information. Completed records will be reviewed and approved by QMCR before being publicly released. QMCR ensures that all records are kept up to date and issues are resolved in a timely manner.

Quality Improvement (QI)

Providing leadership in research quality and implementing initiatives that promote research excellence (e.g. promoting awareness of University policies and procedures, as well as national and international regulations, guidance to PIs, Faculties, Departments etc through seminars, workshops or one-on-one consultation). QMCR will serve as a resource regarding adherence to regulatory and ethical requirements as well as the conduct of good clinical practices.

Quality Control (QC)

Monitoring Principal Investigator-initiated studies being conducted at the University, Alberta Health Services and Covenant Health (selection methods considered include volunteer basis, random or risk-based selection). QMCR will also provide, although to a lesser extent, oversight to industry-driven trials that have their own monitors.

Quality Assurance (QA)

For-cause auditing of any human research, as well as random/risk-based selection of studies to evaluate performance of quality improvement and quality control mechanisms. We will also assess and advise the Health Research Ethics Board (Panels A and B) and NACTRC, on their policies and performance.