| Trial lifecycle and network activity domains | I-ACT | c4c | MICYRN |
|---|---|---|---|
| Indicative indicators of research capacity/capability | Elapsed time for c4c to complete site form from when request sent by the Single Point of Contact |
Number of child health investigators participating in interventional clinical trials in Canada Number of regulated child health, interventional clinical trials conducted in Canada |
|
| Site identification/feasibility indicators |
Elapsed time for the site to complete the study specific feasibility assessment questionnaire Elapsed time for signing the Confidentiality Disclosure Agreements between Sponsor/Single Point of Contact/National Hub/Site |
||
| Trial Start up indicators |
Time from receipt of budget to final budget approval Time from receipt of contract to final contract approval Time from first ancillary protocol review to final ancillary protocol review Time from submission of initial IRB application to final IRB approval Time from receipt of study start-up packet to site initiation visit |
Elapsed time between contract submission and contract signing date by the site Elapsed time between submission of a c4c reviewed protocol to the Independent Ethics Committee (IEC) and approval of the protocol by the IEC Elapsed time between final review of protocol by c4c and National Competent Authority submission Elapsed time between protocol approval to first site activated Elapsed time from site selection to site activation Elapsed time between contract signed and site activation Number of sites activated (opened) on time |
Study start up time |
| Recruitment/Enrolment indicators |
Time from receipt of study start-up packet from first patient consented Time from site initiation visit to first patient consented Accrual ratio Time to fully enrol patients in a study Percentage of targeted enrolment goal met Percentage of patients completing study |
Number of patients screened but failed to enrol Elapsed time from site activation to last patient enrolled Number of sites achieving agreed recruitment targets |
Time from site initiation to first patient enrolled Percentage of targeted participants enrolled |