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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