Once a protocol has been finalized, next steps include:
- The methodological centre and Company sign a Research Agreement.
- The EXCITE Safety Advisory Committee provides feedback on possible safety considerations.
- The company/manufacturer obtains an Investigational Testing Authorization from Health Canada, if required.
- The methodological centre performs study start-up activities and participating sites can begin recruiting patients.
Company will receive monthly evaluation status reports from the date the evaluation begins. As well, Company, Methodological Centre and EXCITE participate in quarterly meetings to review evaluation progress and discuss any other items relevant to the parties.
To maintain the credibility and objectivity of the study, clinical data will not be disclosed until the final report is issued.
The methodological centre prepares the final report, which includes a statistical analysis of the data and related conclusions, and submits it to the company. If the data is supportive, the EXCITE Management Board makes a decision regarding recommendations to the Ministry of Health and Long-Term Care for adoption (this does not preclude MOHLTC soliciting other inputs as per their decision making requirements). The decision will be communicated to the Ministry only after the technology has obtained licensing approval from Health Canada, which is the responsibility of the health technology company (as per regulations).
TIMING: The evaluation process takes 18 to 36 months, depending on the technology and study design.