Table 3.
Resources to support clinical trial registration and results reporting
| QUESTION (number of participants who viewed question) | No. | Percentage |
|---|---|---|
| Does the organization have an electronic system for managing trial registration or results reporting? (N = 366)a | ||
| Yesb | 68 | 19% |
| No | 272 | 74% |
| Don’t know | 26 | 7% |
| Which functions do staff who support registration and results reporting perform (N = 342)c | ||
| Group training (e.g., classroom style) | 61 | 18% |
| Individual training | 151 | 44% |
| Enter data for principal investigators (PIs) | 174 | 51% |
| Maintain an educational website | 57 | 17% |
| Notify PIs about problems or sanctions | 241 | 70% |
| Assistance with analysis | 58 | 17% |
| Respond to questions | 241 | 70% |
| Review problem records | 262 | 77% |
| Other | 28 | 8% |
| Don’t know | 22 | 6% |
| Skipped (did not answer) | 0 | 0% |
| What is the highest qualification of any staff member? (N = 315)d | ||
| High school | 11 | 3% |
| Bachelors | 68 | 22% |
| Masters | 123 | 39% |
| Higher degreed | 109 | 35% |
| Skipped (did not answer) | 4 | 1% |
| Does the organization monitor compliance with results reporting requirements? (N = 116) | ||
| Yes | 99 | 85% |
| No | 10 | 9% |
| Don’t know | 7 | 6% |
| Skipped (did not answer) | 0 | 0% |
| Who monitors compliance with results reporting requirements? (N = 99)c,f | ||
| PRS administrator | 85 | 86% |
| Institutional review board (IRB)g | 11 | 11% |
| Other | 20 | 20% |
| Don’t know | 0 | 0% |
| Skipped (did not answer) | 0 | 0% |
| Number of full-time equivalent (FTE) staff (N = 287)h | Median = 0.08 | IQR = 0.02 to 0.25 |
aAn answer to this question was required for an account to be included in the analysis; accounts that did not see or skipped this question were excluded from all analyses
bOf the 68 accounts that use an electronic management system (“computer software”), 2 (3%) use an application programming interface (API) to communicate with ClinicalTrials.gov
cBecause participants could “check all that apply,” the sum of all categories exceeds the number of participants who responded (i.e., some participants selected multiple responses)
dThe number of possible responses (i.e., the denominator) includes the accounts with a relevant policy that viewed this question. The number of accounts that viewed each question is less than the total number of accounts in the study because (1) participants did not see all questions because of skip logic, and (2) some participants discontinued the survey before viewing all questions
eHigher degrees include JD (N = 21, 7%), PhD (N = 69, 22%), and MD (N = 32, 10%); 13 accounts selected 2 higher degrees (8 both PhD and JD, 5 both PhD and MD)
fThe number of possible responses was limited to the accounts that reported monitoring compliance with their results reporting policy
gOf the 11 accounts reporting that IRBs monitor trial registration, 4 indicated that the IRB requires registration for approval for some (N = 3) or all trials (N = 1)
hResults are the median and interquartile range. We also calculated mean = 0.3, standard deviation = 0.6