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Table 3 Resources to support clinical trial registration and results reporting

From: Clinical trial registration and reporting: a survey of academic organizations in the United States

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
  1. 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
  2. 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
  3. 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)
  4. 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
  5. 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)
  6. fThe number of possible responses was limited to the accounts that reported monitoring compliance with their results reporting policy
  7. 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)
  8. hResults are the median and interquartile range. We also calculated mean = 0.3, standard deviation = 0.6