I researched on the TNBC trial posting to clinical
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Posted On: 01/30/2019 2:13:39 AM
I researched on the TNBC trial posting to clinicaltrials.gov and found it must be submitted at least 21 days after first patient is injected. Also some of the recent TNBC trials started a year or more after FDA approval and posting to clinicaltrials.gov, even some studies with the current PI cydy is using, who is considered THE expert with TNBC. If the trial starts in Q1, it will be a incredible remarkable feat, though there will some ‘realist’ will be complaining that it should have been sooner.
https://clinicaltrials.gov/ct2/manage-recs/fdaaa
And
https://clinicaltrials.gov/ct2/manage-recs/faq#after
Can I register a study after it has started, has closed to recruitment, or has been completed?
Yes, you can register a study on ClinicalTrials.gov at any time. Please note that, in general, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant.
To comply with FDAAA 801, must I submit information to ClinicalTrials.gov, or can I use another registry or results database?
You must use ClinicalTrials.gov to fulfill the requirements of FDAAA 801 (PDF). FDAAA 801 requires Responsible Parties to submit clinical trial information to the Director of the National Institutes of Health (NIH) for inclusion in the registry and results database established via ClinicalTrials.gov.
Who Is Responsible for Registering Trials and Submitting Results?
The responsible party for an applicable clinical trial (ACT) must register the trial and submit results information. The responsible party is defined as:
The sponsor of the clinical trial, as defined in 21 CFR 50.3; or
The principal investigator (PI) of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the PI 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
https://clinicaltrials.gov/ct2/manage-recs/fdaaa
And
https://clinicaltrials.gov/ct2/manage-recs/faq#after
Can I register a study after it has started, has closed to recruitment, or has been completed?
Yes, you can register a study on ClinicalTrials.gov at any time. Please note that, in general, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant.
To comply with FDAAA 801, must I submit information to ClinicalTrials.gov, or can I use another registry or results database?
You must use ClinicalTrials.gov to fulfill the requirements of FDAAA 801 (PDF). FDAAA 801 requires Responsible Parties to submit clinical trial information to the Director of the National Institutes of Health (NIH) for inclusion in the registry and results database established via ClinicalTrials.gov.
Who Is Responsible for Registering Trials and Submitting Results?
The responsible party for an applicable clinical trial (ACT) must register the trial and submit results information. The responsible party is defined as:
The sponsor of the clinical trial, as defined in 21 CFR 50.3; or
The principal investigator (PI) of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the PI 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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