Contract table of contents

ARTICLE H.15. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN CLINICALTRIALS.GOV

The Food and Drug Administration Amendments Act of 2007 (FDAAA) at:  http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf , Title VIII, expands the National Institutes of Health's (NIH's) clinical trials registry and results database known as ClinicalTrials.gov and imposes new requirements that apply to specified "applicable clinical trials," including those supported in whole or in part by NIH funds. FDAAA requires:

• 
  the registration of certain "applicable clinical trials" (see Definitions at: http://grants.nih.gov/ClinicalTrials_fdaaa/definitions.htm ) in ClinicalTrials.gov no later than 21 days after the first subject is enrolled; and
  
• 
  the reporting of summary results information (including adverse events) no later than 1 year after the completion date (See Definitions at link above) for registered applicable clinical trials involving drugs that are approved under section 505 of the Food, Drug and Cosmetic Act (FDCA) or licensed under section 351 of the PHS Act, biologics, or of devices that are cleared under section 510k of FDCA.  
  

In addition, the Contractor shall notify the Contracting Officer's Representative (COR), with the trial registration number (NCT number), once the registration is accomplished.  This notification may be included in the Technical Progress Report covering the period in which registration occurred, or as a stand alone notification.

The [Contractor is the Sponsor, therefore/Government is the Sponsor and delegates the Contractor's Principal Investigator as/Government is the Sponsor, therefore]  the "Responsible Party" for the purposes of compliance with FDAAA which includes registration (and results reporting, if required) of applicable clinical trial(s) performed under this contract in the Government database, ClinicalTrials.gov ( http://www.ClinicalTrials.gov ).

Additional information is available at: http://prsinfo.clinicaltrials.gov .
 

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****(USE BELOW IN EACH CONTRACT PARTICIPATING IN A  MULTI-CENTER "APPLICABLE CLINICAL TRIAL," EXCEPT DO NOT USE IF THE CONTRACTOR IS DESIGNATED AS THE "RESPONSIBLE PARTY."  Note :  The Contractor that is designated as the "Responsible Party" will use the previous Article, above . ADDITIONAL INFORMATION TO COMPLETE THIS ITEM: Second paragraph:  Insert the Name of the Individual (and Contractor) designated as the "Responsible Party" of the Multi-Center Trial. Note:   The Contracting Officer should consult with the Project Officer/Contracting Officer's Representative (COR) to assist in making this determination .)****

ARTICLE H.16. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS CLINICALTRIALS.GOV

The Food and Drug Administration Amendments Act of 2007 (FDAAA), at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf , Title VIII, expands National Institutes of Health's (NIH's) clinical trials registry and results database known as ClinicalTrials.gov and imposes new requirements that apply to specified "applicable clinical trials," including those supported in whole or in part by NIH funds. FDAAA requires: 

• 
  the registration of certain "applicable clinical trials" (see Definitions http://grants.nih.gov/ClinicalTrials_fdaaa/definitions.htm ) in ClinicalTrials.gov no later than 21 days after the first subject is enrolled; and
  
• 
  the reporting of summary results information (including adverse events) no later than 1 year after the completion date (See Definitions at link above) for registered applicable clinical trials involving drugs that are approved under section 505 of the Food, Drug and Cosmetic Act (FDCA) or licensed under section 351 of the PHS Act, biologics, or of devices that are cleared under section 510k of FDCA.
   
  

                                                                                 is the "Responsible Party" for the purposes of compliance with FDAAA which includes registration (and results reporting, if required) of the applicable clinical trial(s) performed under this contract in the Government database, ClinicalTrials.gov ( http://www.ClinicalTrials.gov ). 

The contractor shall provide the "Responsible Party" with all essential data for timely compliance with ClinicalTrials.gov reporting requirements.

Additional information is available at: http://prsinfo.clinicaltrials.gov .
 

240

****(USE BELOW IN SOLICITATIONS AND CONTRACTS FOR HIV ANTIRETROVIRAL TREATMENT TRIALS THAT WILL TAKE PLACE IN WHOLE OR IN PART IN DEVELOPING COUNTRIES - DEFINED AS THE LOW- AND MIDDLE-INCOME ECONOMIES, USING WORLD BANK CLASSIFICATIONS - AND THE OFFEROR PLANNED TO DEVELOP SOURCES TO PROVIDE TREATMENT OF TRIAL PARTICIPANTS AFTER THEIR COMPLETION OF THE TRIAL.)****

ARTICLE H.17. HIV ANTIRETROVIRAL TREATMENT TRIALS

The Contractor shall work with the host countries' authorities and other stakeholders in accordance with the approved plan to develop sources to provide HIV antiretroviral treatment to participants of the trials contracted for under this contract after the participants' completion of the trial.

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****(USE BELOW, WHEN HUMAN MATERIALS WILL BE ACQUIRED AND/OR GENERATED UNDER THE CONTRACT.)****