Only 19 percent of organizations use computer software to monitor compliance with Final Rule
FRIDAY, May 4, 2018 (HealthDay News) — Many organizations are not meeting the trial registration and results reporting requirements clarified by “The Final Rule,” which had a compliance date of April 18, 2017, according to a study published online May 1 in BMC Medicine.
Evan Mayo-Wilson, D.Phil., from the Johns Hopkins University Bloomberg School of Public Health in Baltimore, and colleagues surveyed Protocol Registration and Results System (PRS) accounts classified by ClinicalTrials.gov as a University/Organization. One PRS administrator completed the survey for each organization account.
The researchers found that in August 2016, there were 47,701 records for 783 eligible organization accounts. A total of 366 participating organizations (47 percent) included 85 percent of the records. Clinical and Translational Science Award holders, cancer centers, and large organizations were more likely to participate compared with other organizations. Forty-three and 35 percent of accounts had a registration or results reporting policy. Of those with policies, 11 and 35 percent reported that trials must be registered before granting of institutional review board approval or before beginning enrollment, respectively. Nineteen percent of organizations used computer software to monitor compliance; an investigator was penalized for non-compliance by one organization. The median number of full-time-equivalent staff was 0.08 among the 78 percent of accounts reporting that they allocate staff to fulfill ClinicalTrials.gov registration and reporting requirements.
“Most organizations appear to be unprepared to meet the new requirements,” the authors write.
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