4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
MICYRN - Maternal Infant Child and Youth Research Network |
|
| Documented adherence to GCP guideline | Yes | MICYRN has established a Clinical Trial consortium (see website), a group made of scientific and operational leads of Clinical trial unit or clinical research unit based at each MICYRN institution member. Every CTU or CRU has developed its own SOP. MICYRN, an ARO and a Sponsor, also has its own SOP securely stored on its sharepoint server. Those SOP are not publicly available but available in case of audit or inspection. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | MICYRN staff (directors, project managers, monitors, quality assurance lead) has got TCPS2 (Tri-Council Policy Statement: Ethical conduct for Research Involving Humans) certification, renewed on a regular basis. MICYRN provide an ethics submission and review consultation service to investigators or sponsors looking for help and advices for pediatric consent/assent development and ethics application submission to Ethics committee. MICYRN a partner of CHEER: The Canadian Collaboration for Child Health: Efficiency and Excellence in the Ethics Review of Research (cheerchildhealth.ca) |
| Documented adherence to ethical considerations | Yes | all Research Ethics Board based at each of the MICYRN institution members and reviewing pediatric application have at least one pediatric expert member. Some MICYRN institution members, standing alone as a Pediatric academic hospital and research centre, have their own REB dedicated to review pediatric studies. Examples: BC Children Hospital in Vancouver, SickKids Hospital in Toronto, Children Hospital of Eastern Ontario in Ottawa, Sainte Justine Hospital in Montreal. |
| Availability of Standard Operating Procedures (SOP) | Yes | MICYRN, as an ARO and a sponsor, has developed it own set of SOP, stored on its sharepoint and available for audit and inspection purpose. MICYRN shares its SOP with its institution members. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | MICYRN, as a sponsor and an ARO, has developed capacities to monitor regulated trials. MICYRN has hired one full time monitor and has contracted with several monitors spread across the country to monitor trials conducted at its institution members. MICYRN has its own quality assurance lead. |
| Capacity to monitor performance of collaborating centres | Yes | RareKids-CAN is co-funding Clinical trial Navigators, embedded in the CTU of each of the MICYRN institution members. One of the role of the CTN is to coordinate data collection locally to support quality improvement and performance metric initiatives to capture study start up timelines, and other measures of success such as the total number of rare disease clinical trials taking place and the total number of investigators involved in pediatric rare disease clinical trials. |
| Quality control and quality assurance, raceability and data safety | Yes | Funded by RareKids-CAN, MICYRN has hired a Quality Assurance Lead. This individual is currently reviewing, updating, and completing our set of SOP. MICYRN SOP are not publicly available. |