What is primary completion?
What is primary completion?
Primary completion date. The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.
What does enrolling by invitation mean?
Glossary: Enrolling by Invitation A clinical study that selects its participants from a population, or group of people, decided on in advance by the researchers.
When should I update my ClinicalTrials government?
Responsible Parties should update their records within 30 days of a change to any of the following: Recruitment Status and Overall Recruitment Status data elements on ClinicalTrials.gov. Completion Date (See Primary Completion Date data element on ClinicalTrials.gov)
Who needs to register ClinicalTrials?
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.
Do you have to register clinical trials?
Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) requires responsible parties to register clinical trials and submit summary results to ClinicalTrials.gov. The law applies to certain clinical trials of drug, biological, and device products and has been in effect since September 27, 2007.
What is the meaning of date of completion?
Date of Completion means the date of final completion of the project in all respect. Date of Completion or “completed” means the date that a communications service provider offers or facilitates broadband service delivered at or above 25 megabits per second of download speed and 3 megabits per second of upload speed in a targeted service area.
What is the estimated primary completion date?
The “estimated primary completion date” is the date that the researchers think will be the primary completion date for the study. The primary completion date is the term used on ClinicalTrials.gov for “completion date” defined in Section 801 of the Food and Drug Administration Amendments Act of 2007.
What is the date of completion for broadband?
Date of Completion or “ completed ” means the date that a communications service provider offers or facilitates broadband service delivered at or above 25 megabits per second of download speed and 3 megabits per second of upload speed in a targeted service area. Sample 1 Sample 2 Sample 3
What is the deadline for submission of results information?
The clinical trial results information submission deadlines for ACTs that fall within the scope of 42 CFR 11.42 are set out in 42 CFR 11.44. The standard submission deadline for results information is no later than 1 year after the study’s primary completion date.
