NEWSLETTER

WINTER 2017

New Regulations and NIH Policy:  ClinicalTrials.gov Registration and Results Reporting
 

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In September 2016, HHS released a Final Rule implementing the 2007 FDAAA statutory requirement for “Applicable Clinical Trials” (generally FDA-regulated drug, biologic, and device studies) to register and report results on ClinicalTrials.gov.  The regulations are largely the same as what had been required previously under FDAAA.  However, at the same time, NIH released a new policy stating that all NIH-funded Clinical Trials (including biomedical and behavioral intervention studies) must also register and report results on ClinicalTrials.gov. This is a significant expansion of the requirements.

The Research Compliance Committee recently approved a revised policy and procedure that complies  with the updated requirements. See NWRC.RIM.06, Clinical Trial Registration and Reporting, on the Research Compliance Policies web page.

If you are the Responsible Party for a clinical trial, you must ensure compliance with these requirements.  In general, the Responsible Party is:

  • The prime awardee investigator for an NIH-funded study
  • The sponsor or sponsor-investigator for an FDA-regulated study

The above policy and procedure provides information on what studies must comply, what must be submitted to ClinicalTrials.gov, and how to access the site.

Deadlines for Submission of Information to ClinicalTrials.gov

Registration:  Within 21 days of enrolling the first participant.

Results:  Within one year of the Primary Completion Date.  The Primary Completion Date is defined as “the date that the final subject was examined or received an intervention for the purpose of collecting the data for the primary outcome measure.”

Effective Date and Timelines for Compliance

The Effective Date for both the Final Rule and the NIH Policy is January 18, 2017.  For studies currently in progress at that time, follow the chart below.

Type of Study

Registration

Results Reporting

Applicable Clinical Trial (generally FDA-regulated drug, biologic, or device studies)

All studies must be in compliance by April 18, 2017.

Submit results if the Primary Completion Date is on or after January 18, 2017.

NIH-Funded Clinical Trial (including biomedical or behavioral interventions)

Applies only to proposals received by NIH on or after January 18, 2017.

Applies only to proposals received by NIH on or after January 18, 2017.

The Research Compliance team will monitor compliance with the above requirements in the course of our routine Quality Improvement-Monitoring visits going forward. Please don’t hesitate to contact us with questions at CHR_ResCompTeam.

 

Refresher Training for Human Subjects Protection
 

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KPNW began using CITI in 2014 to provide human subjects protection training. The training is valid for three years. KPNW researchers and study staff who completed one or both of CITI's two basic human subjects protection courses (Biomedical and Social-Behavioral-Educational) in 2014 will need to renew training certification this summer and fall by completing a refresher course.

Required modules for the refresher course  cover the same topics as the basic course. The good news is that the refresher modules are shorter than the basic ones. Each refresher module has a link to the corresponding module from the basic course for easy reference if you need to review a topic. CITI sends an email reminder and automatically adds refresher courses to a user’s course list 90 days before current training expires.

You can check your current training status and previously completed coursework by logging into CITI. You can also check training details by logging into the eIRB system and clicking on your name in the upper right corner of the home page. Select KP Training Details from the Select View drop-down menu to view course names, completion dates, and expiration dates. CITI training information is updated in the eIRB nightly.

TIP: Your name and email address must match exactly in the two accounts for CITI training details to be exported into your eIRB account. If CITI training details do not appear in your eIRB account, check your name and email address in both accounts and update information as needed to make the two accounts match. Training details should appear in your eIRB account after the nightly update.

For more information about training requirements for KPNW researchers, see the Training & Education page on the Research Compliance website.

Contact CHR_ResCompTeam@kpchr.org if you have any questions about CITI training.

 

Quality Improvement Monitoring Program Update
 

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We are in Year 3 of the Quality Improvement - Monitoring program and wanted to give you an update of how things are going and were we are headed.

Accomplishments

We have completed 36 visits to date.

We streamlined monitoring communications and forms for data-only studies, which has helped reduce the burden and confusion for researchers.

The assessment forms are now in REDCap, as is all completed monitoring visit information. This allows us to run reports and get a better picture of the program.

We also created a survey in REDCap and sent it to researchers and PMs at the end of last year. We have received 15 responses. We will send the survey out a couple of times a year and will use the information collected to track trends and improve the program.

Time Spent by Researchers

The average time spend by researchers for monitoring of data-only studies was 60 minutes for prep and 28 minutes for meetings. For all other studies the prep time average was 112 minutes, pre-meetings averaged 24 minutes, and meetings averaged 48 minutes.

Findings                                     

The most significant finding has been initial review questionnaire (IRQ) inconsistencies. This has been greatly reduced since the rollout of the new eIRB.

Future Plans                                                     

We propose revising the assessment form to include:

  • Consent and authorization elements
  • Internal inconsistencies
  • IRB and Investigator reliance agreements tracking
  • ClincialTrials.gov registration

We will develop a mechanism for tracking completion of follow-up activities for both researchers and compliance.

Thank you to all of the researchers and research staff who have participated in monitoring. 

 

IRB Tips and New Information

 

Announcements

Your Feedback Requested!

Help the Research Compliance team by completing an anonymous survey about your experience with the Research Compliance Department's customer service. We appreciate your input!

Click here to access the survey.

NIH Requirement for Single IRB Review – NEW EFFECTIVE DATE

As reported in our Summer 2016 newsletter, NIH has released a policy to require single IRB review for many multi-site studies receiving NIH funding. The effective date of this policy has been moved from May 2017 to September 25, 2017. This will affect proposals submitted on or after the September date. Read more details here.

Final Changes to the Common Rule

On January 19, 2017, the US Department of Health and Human Services published a revision to the regulations that govern federally funded human subjects research (45 CFR 46 Subpart A). This regulation is also known as the “Common Rule.”.= This is the first revision since 1991. The effective date to begin these changes is January 20, 2018. More information will follow, but you can find a good overview of these changes here.

Tips

Graphics Versions of Consent Forms

When a study includes a graphic consent form, the Microsoft Word version of the document should be uploaded on the “Consent Forms and Recruitment Materials” page in the eIRB so the IRB can review and approve the text. Final versions of graphic consent forms should be uploaded on the “Supporting Documents” page and clearly labeled as the graphics version. Finally, when the study team submits the modification to add the finalized graphic version of the form to the project, it must verify under the summary of the modification (item #4 on the “Modification Information” page) that it has compared the approved Word version of the document with the graphic version and that they both are consistent.

Before You Share De-Identified or Aggregate Data Sets

Aggregate data sets may often be released without a compliance review, but you should always check your data set against the Rules on Sharing Aggregate Data and follow the Aggregate Data Transfer Flowchart when sending aggregate data sets outside the region. These resources are also available on our Sharing Data web page.