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. 2024 Jun 20;58(5):953–964. doi: 10.1007/s43441-024-00663-0
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