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From the Office for Clinical Research (OCR)
Important Changes to ClinicalTrials.gov
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| Clinicaltrials.gov Protocol Registration System Changes in US Public Law 110-85 (FDAAA) | |||
| What is the U.S. Public Law 110-85 (FDAAA)? | |||
| The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) was passed on September 27, 2007. The law requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. | |||
| What are the changes? | |||
| Previously:
Designated staff was able to update, edit and release protocol records in Clinicaltrials.gov. |
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| Current:
As of August 18, 2011, ClinicalTrials.gov now requires all PIs of investigator-initiated protocols registered to clinicaltrials.gov to establish an account and be listed as the Responsible Party. Designated staff may continue to update and edit protocol records; however, sponsor-investigators deemed as the “Responsible Party” are now responsible to review the final protocol record and release it into the system. |
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| Who is the Responsible Party and who do these changes in Clinicaltrials.gov apply to? | |||
| Responsible Party includes:
Sponsor-Investigators: the individual who both initiates and conducts the study (PIs of PI- Initiated trials). AND Principal Investigators: the individual who serves as the principal investigator and is designated as responsible party by a sponsor, grantee, contractor, or awardee, as long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements for the submission of clinical trial information. |
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| Who do these changes NOT apply to? | |||
| These changes do not apply to PIs of Industry-Sponsored trials or Site PIs of a larger study (where another PI at another institution is the Sponsor-PI). | |||
| How do these changes affect Emory Investigators? | |||
| The Responsible Party (all Sponsor-Investigator or Principal Investigator as define above) must be a registered user of Clinicaltrials.gov. Per policy changes, the Responsible Party is now required to review and release all updates.
Note: Protocol records should be updated every 6 months and final results should be entered within 1 year of the conclusion of the trial if the protocol qualifies per U.S. Public Law 110-85 FDAAA requirements. |
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| What if I don’t have a user name and password for ClinicalTrials.gov? | |
The Office for Clinical Research is available to assist in the following:
For assistance please send an email to: ocr@emory.edu. |
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| Where can additional information be obtained pertaining to these changes? | |
| PRS and U.S. Public Law 110-85: http://prsinfo.clinicaltrials.gov/fdaaa.html
PRS Information: http://prsinfo.clinicaltrials.gov/ |
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| SiteMinder is being replaced with Emory Research Management System (ERMS) for Study Visit Tracking!
ERMS Visit Tracking (EVT) will be a huge improvement to the efficiency of your process, by significantly increasing billing reconciliation and assisting the Office for Clinical Research with invoicing your clinical research studies. Implementation of ERMS Visit Tracking is Monday, November 14, 2011. More information coming soon!!!! |
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| Upcoming Courses and Events | ||
| If you are Clinical Research Coordinator, Department Administrator, Clinical Research Nurses, Study Coordinator, or Principal Investigator, we encourage you to sign up for a course/event below.
Please note course dates, locations & times are subject to change. |
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| Course(s)/Event(s): | Date(s): | Location and Time: |
| How to Conduct Clinical Research At Emory: The Basics (2 day class) | November 4 & 11, 2011
December 2 & 9, 2011 |
1599 Clifton Road, 1st Floor, Room 1D
8:00am – 1:00pm |
| Basic Life Support for Emory University Research Staff
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November 9, 2011 – Full
December 14, 2011 |
SOM Simulation Lab, Ground Floor, Room B27
8:30am – 12:00pm |
| Emory Research Management System (ERMS)
*Includes content on the new ERMS Visit Tracking |
November 18, 2011
December 16, 2011 |
1599 Clifton Road, 1st Floor, Room 1.380
10:30am – 12:00pm |
| For more information or to register for a course/event, please visit our website:
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