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. 2024 Jun 20;58(5):953–964. doi: 10.1007/s43441-024-00663-0
1 Elapsed time for the site to complete the study specific feasibility assessment questionnaire
2 Elapsed time for c4c to complete the site form from when request sent by the Single Point of Contact
3 Elapsed time for signing the Confidentiality Disclosure Agreements between Sponsor/Single Point of Contact/National Hub/Site
4 Number of sites activated (opened) on time
5 Elapsed time from site selection to site activation
6 Elapsed time between protocol approval to first site activated
7 Elapsed time between contract signed and site activation
8 Elapsed time between contract submission and contract signing date by the site
9 Elapsed time between submission of a c4c reviewed protocol to the Independent Ethics Committee (IEC) and approval of the protocol by the IEC
10 Elapsed time between final review of protocol by c4c and National Competent Authority submission
11 Number of sites achieving agreed recruitment targets
12 Number of patients screened but failed to enrol
13 Elapsed time from site activation to last patient enrolled