Several of the federal clinical trial reform efforts announced for 2017, reported on most recently in the Dec. 16, 2016, issue of the CCTS Digest, have gone into effect. This includes the ClinicalTrial.gov requirements to register and report results, which applies to all NIH funded or partially funded studies initiated on or after Jan. 18, 2017.
CCTS has developed several new resources to help raise awareness about the requirements and the to empower investigators with the tools and expertise to successfully meet the regulatory expectations and avoid potential penalties. Additional guidance and support with regulatory requirements (both federal and UAB) are available on request by emailing us at
CCTS Solutions
- Our new video, “ClinicalTrials.gov: New Clinical Trials Policies,” has a serious title and message for clinical trialists and their teams, but delivers it with humor and brevity (and a catchy tune!). Our hope is the video will go viral, helping raise awareness of the requirements to register clinical trials and report their results. Please watch and like and share with others!
- The new Clinical Translation landing page reviews the federal policies taking effect in 2017 and provides a list of websites, checklists, trainings, videos, and articles for investigators to learn more, including how to use the Protocol Registration and Results System, the database for entering clinical trial results on clinicaltrials.gov.
- CCTS has added a special consultation clinic to its First Wednesday Drop-in Clinics line up, which will provide investigators with the opportunity to talk to one of our Clinical Research Support Program (CRSP) specialists about meeting the new clinicaltrials.gov requirements. A second clinic will take place in conjunction with the Biostatistics clinic on the third Wed. of the month. Both clinics take place at PCAMS from 11:30am-1pm. No appointment is necessary.
- Two additional upcoming trainings will provide overviews of the new requirements. The CCTS Lunch and Learn will take place on February 21 from 11:45am-1pm in Spain Auditorium. The CCTS Research Seminar on March 16 from noon-1pm at PCAMS. Visit our Events page for more information about these and other CCTS learning opportunities.