Table 1.
Criterion | SRCs | ||||
---|---|---|---|---|---|
Baseline n = 30* |
Intervention n = 29 |
Net change |
|||
n | % | n | % | % | |
Review content | |||||
Review for scientific quality | 26 | 86.7 | 29 | 100.0 | 13.3 |
Review for local operational feasibility | 25 | 83.3 | 24 | 82.8 | −0.5 |
Locally reviewed protocols | 26 | 86.7 | 29 | 100.0 | 13.3 |
Centrally reviewed protocols | 25 | 83.3 | 24 | 82.8 | −0.5 |
Protocol eligibility | |||||
All protocols are eligible for SRC review or exemption criteria are limited to recommended types of protocols | 23 | 76.7 | 26 | 89.7 | 13.0 |
Protocols that fit criteria for exemption can still be reviewed (includes SRCs that do not exempt protocols) | 25 | 83.3 | 28 | 96.6 | 13.3 |
Institutional Review Board (IRB) and/or institutional officials may forward to the SRC any protocol at any time | 21 | 70.0 | 26 | 89.7 | 19.7 |
Reviewers per protocol | |||||
At least one medical review | 26 | 86.7 | 29 | 100.0 | 3.0 |
Statistician not also acting as a medical reviewer | 4 | 13.3 | 15 | 53.6** | 40.3 |
Content experts as needed | 24 | 80.0 | 28 | 96.6 | 16.6 |
Reviewer qualifications | |||||
Have requisite expertise | 25 | 83.3 | 29 | 100.0 | 16.7 |
Not on research team | 22 | 73.3 | 27 | 93.1 | 19.8 |
No conflict of interest | 21 | 70.0 | 25 | 86.2 | 16.2 |
Is available to perform review in timely manner | 25 | 83.3 | 28 | 96.6 | 13.3 |
Is willing to undertake the task | 25 | 83.3 | 28 | 96.6 | 13.3 |
Related institutional policies | |||||
Coordination of the SRC with the IRB | 25 | 83.3 | 28 | 96.6 | 13.3 |
IRB has access to SRC review | 24 | 80.0 | 27 | 93.1 | 13.1 |
Four sites without an SRC at baseline are included in the denominator as one SRC per site; each of these sites established a single SRC process at intervention.
Data are missing for one SRC. The denominator for this proportion is 28 instead of 29.