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How do I register for clinical trials?
Check to see whether your organization already has a PRS organization account. Apply for a PRS account. See how to apply for an account on ClinicalTrials.gov. Logon to PRS on the PRS Login Page. Enter the required and optional data elements. Preview, inspect, and submit the record.
How do I register for a clinical trial?
Check to see whether your organization already has a PRS organization account. Apply for a PRS account. See how to apply for an account on ClinicalTrials.gov. Logon to PRS on the PRS Login Page. Enter the required and optional data elements. Preview, inspect, and submit the record.
Why are clinical trials registered?
Clinical trial registration is the practice of documenting clinical trials before they are performed in a clinical trial registry to combat publication bias and selective reporting. Registration of clinical trials is required in some countries and is increasingly being standardized.
What trials must be registered on ClinicalTrials gov?
Which Trials Must Be Registered on ClinicalTrials.gov? Registration is required for studies that meet the definition of an “applicable clinical trial” (ACT) and either were initiated after September 27, 2007, or initiated on or before that date and were still ongoing as of December 26, 2007.
What is a registration trial FDA?
A trial that is branded “registration” means that it. Is planned to move forward for review by the. FDA as either a new agent, or to expand the. Labeling for new indications.
What is an applicable clinical trial?
Applicable Clinical Trial (ACT) is the term used in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FD AAA) (PL 110-85) to designate the scope of trials that may be subject to the registration and reporting requirements in FD AAA.
Is this an applicable clinical trial under Data?
No. A clinical investigation of a drug can be an Applicable Drug Clinical Trial under FD AAA 801 even if it does not require an IND, and a clinical investigation of a device can be an Applicable Device Clinical Trial whether an IDE is required.
What is the FDA's role in clinical trials?
What is FDA's role in approving new drugs and medical treatments? FDA makes sure medical treatments are safe and effective for people to use. FDA staff meet with researchers and perform inspections of clinical trial study sites to protect the rights of patients and to verify the quality and integrity of the data.
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